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Conference on Drug Pricing Inject New Statistics Into Debate, Few New Insights (Part 2 of 2)

Posted on November 9, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The first part of this article described the upward pressures on costs and some of the philosophical debates over remedies. This section continues the discussion with several different angles on costs.

Universal access and innovation

It’s easy to call health care a human right. But consider an analogy: housing could also be considered a human right, yet no one has the right to a twenty-room mansion. Modern drug and genetic research are creating the equivalents of many twenty-room mansions, and taking up residence means the difference between life and death for someone, or perhaps between a long productive life and one of pain and deformity.

Universal access, often through a single-payer system, is in widespread use in every developed country except the United States. Both universal access and single payer are credited with keeping down the costs of health care, including drugs. It makes sense to link single-payer with lower drug costs, because of the basic rules of economics: size gives a buyer clout, as we can see in the ways Walmart lords it over their suppliers (documented in a 2006 book, The Wal-Mart Effect, by Charles Fishman). At the conference, Sean Dickson from the Pew Charitable Trusts gave what he called an “economics 101 course” of health care and how the industry diverges from an ideal market. (He did not come out in favor of single-payer, though.)

How much fat can be cut from pharma? My guess is a lot. As we saw in the previous section, profits from pharmaceuticals tower above profits in most industries. But we don’t have to stop by simply shaving payments to shareholders, or even management compensation. I know from attending extravagent health care conferences that there’s a lot of free cash floating around the health care industry in general, although it’s unevenly distributed. (Many hospitals, nursing homes, and other institutions are struggling to maintain adequate staffing.) In industries possessing such easy money, it does trickle down somewhat. Gaudino pointed out ruefully that health care is one of the few fields left that can give ordinary people a middle-class income, something we don’t want to lose even as employment continues to rise in that space. But easy money also leads to bloat, and this is almost certainly true throughout health care, including pharma.

Even so, projections of the cost of universal access are dizzyingly high, placing pressure on the historic universal access model in Massachusetts and forcing Vermont to give up single-payer. The pressures that could be applied to the health care field by the US government would certainly outweigh the negligible impact that Vermont–with its population of a mere 600,000–could exert. But it’s unlikely that the easy wins falling out of single-payer (squeezing drug companies, eliminating the administrative overhead of handling health insurance) could make up for the staggering costs of adding whole new swaths of a high-need, difficult population to government rolls.

What we need to lower health costs is an overhaul of the way health care systems conceive of patients, taking them from conception to the grave and revamping to treat chronic conditions. T.R. Reid, in his book The Healing of America, says that universal access must come first and that all the rest will gradually follow. I would like to have at least a strong concept throughout the health care system of what the new paradigm will be, before we adopt single-payer. And in theory, adopting that paradigm will fix our cost problems without the wrenching and contentious move to single-payer.

What non-profits can teach us

So how do we recompense manufacturers while getting drugs to low-income people who need them? Some interesting insights did turn up here at the conference, through a panel titled From Development to Delivery Globally. All three speakers operate outside the normal market. One is a representative of Gilead Sciences (mentioned earlier), whereas the other two represent leading non-profits in international health care, Partners in Health and the Bill & Melinda Gates Foundation. Nevertheless, their successes teach us something about how to bend the cost curve in traditional markets.

Flood said that Gilead Sciences made an early commitment to get its AIDS drug to all who needed it, without regard to profit. At first it manufactured the drug and distributed it in sub-Saharan Africa at cost. That failed partly because the cost was still out of reach for most patients, but also because the distribution pipeline was inadequate: logistics and government support were lacking.

So Gilead took a new tack: it licensed the drug to Indian manufacturers who not only could produce it at a very low cost (while maintaining quality), but understood the sub-Saharan areas and had infrastructure there for distributing the drug. This proved highly successful. I’m betting we’ll find more drugs manufactured in India over time.

Hannah Kettler of the Gates Foundation described how they set 50 cents as an affordble price for a meningitis vaccination, then went on to obtain that price in a sustainable manner. The key was to hook up potential buyers and manufacturers in advance. The buyers guaranteed a certain number of bulk purchases if the manufacturers could achieve the desired price. And armed with a huge guaranteed market, the manufacturers scaled up production so as to reduce costs and meet the price goal.

The Gates model looks valuable for a number of drugs: guarantee an advance market and start out manufacturing at a large scale to reduce costs. This will not help with orphan diseases, of course.

More generally, in my opinion, developed countries have to define their incentive to provide aid of any kind–medicine, education, microloans, or whatever. Is it enough of an incentive to empower women and keep population growth under control? To avoid social conflicts that turn into civil wars? To avoid mass emigration and refugee crises? What are solutions worth to us?

The contributions of artificial intelligence

Aside from brief mentions of advanced analytics by Gaudino and Taylor, the promise of computer technology came up mainly in the final panel of the conference, where Petrie-Flom research fellow Sara Gerke offered some examples of massive costs savings that AI has created at various points in the drug development chain. These tend to be isolated success stories, but illustrate a trend that could relieve pressure on prices.

I have reported on the use of AI in drug development in other articles over the years. This section consolidates what I’ve seen: although AI can potentially help at any point in an industry’s business, it seems particularly fertile in two parts of drug development.

The first area is the initial discovery of compounds. Traditional research can be supercharged by analyses of patient genes, simulations of molecule behaviors, and other ways of extracting needles from haystacks.

The second area is the conduct of the clinical trial. Here, techniques being tried by drug companies are variants of what clinicians are doing to engage and monitor patients. For instance, clinical subjects can wear devices with minimal disruption to their lives, and report vital signs back to researchers on an ongoing basis instead of having to come into the researcher’s office. AI can also find suitable subjects, increasing the potential pool. Analytics may reveal early whether a clinical trial is not working, allowing the company to save money by shutting it down early, and avoiding harm to subjects.

Of course, we all look forward to some marvelous breakthrough–the penicillin of the 21st century–that will suddenly open up miracle treatments at low cost for a myriad of illnesses. Current research is pushing this medical eschaton further and further off into the unforeseeable future. We are learning that the genome and human molecules interact in ways that are much more complex than we thought, that a lot is dependent on the larger biome, and that diseases are also cleverer than we thought and able to work around many of our attacks.

Analytics will certainly accelerate medical discoveries. In doing so, it could drastically reduce the costs of drug discovery, and therefore reduce risk and ultimately prices. But stunning new drugs for rare diseases could also vastly increase prices.

Baby steps

I’ll end with a few suggestions made by conference participants to create a more competitive market or reduce prices. Outside of explicit price setting (on which participants were deeply split), the proposals looked like small contributions to a situation that requires something big and bold.

  • Price transparency came up several times.
  • Grogan would like Congress to re-examine reimbursement for Medicare Part D (especially the donut hole and catastrophic coverage) to give both PBMs and vendors incentives to lower costs.
  • Gaudino said that Australia does a much better job than the US of collecting data on the outcomes of using drugs, which they can use to determine whether to approve the drugs. The U.S. payment system is more privatized and fragmented, making it impossible to collect the necessary data.
  • Caljouw praises the efforts of the Massachusetts Health Policy Commission, which has no power to set costs but meets with providers and asks them to reconsider the factors that lead to jacked-up prices.
  • Caljouw also mentioned laws requiring price transparency from PBMs.
  • Several participants suggested reversing the decision that allowed companies to air advertisements directly to consumers. (I’m afraid that if all the misleading drug ads disappeared from the air, a bunch of television networks would go out of business.)
  • Taylor cited pressure by Wall Street on drug companies to maximize prices without regard for the social impacts–an intense kind of pressure felt by no other industry except fossil fuels–and called for the extension of socially responsible investment to drug companies.

I’d like to suggest, in conclusion, that we may be focusing too much on manufacturers, who are taking enormous risks to cure difficult diseases. A University of Southern California study found that 41% of the price is absorbed by intermediaries: wholesalers, pharmacies, PBMs, and insurers. Whether through single-payer or through other changes to the health care system, we can do a lot without constricting innovators.

Conference on Drug Pricing Injects New Statistics Into Debate, Few New Insights (Part 1 of 2)

Posted on November 8, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The price of medications has become a leading social issue, distorting economies around the world and providing easy talking points to politicians of all parties (not that they know how to solve the problem). Last week I attended a conference on the topic at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

On one level, the increasing role that drugs play in health care is salutary. Wouldn’t you rather swallow a pill than go in for surgery, with the attendant risks of anesthesia, postoperative pain opiates, and exposure to the increasingly scary bacteria that lurk in hospitals? Wouldn’t you rather put up with a few (usually) minor side effects of medication than the protracted recovery and discomfort of invasive operations? And even when priced in the tens of thousands, drugs are usually cheaper than the therapies they replace.

But drug costs are also deeply disrupting society. They are more and more dominant in the health care costs that take up nearly a fifth of the total output of the U.S., and the outsized demands that medications put on both private and public pocketbooks lead to drug pricing being a rare bipartisan issue.

Michael Caljouw from Blue Cross Blue Shield of Massachusetts pointed out at the conference that in Massachusetts, health care has skyrocketed from 20% to 45% of entire state budget in 20 years, and similar trends are found in other states. He says that an expensive new drug can “blow through” budgets set a year in advance. Bach cited statistics showing the prices for cancer drugs are rising exponentially, while the drugs get only slightly more effective over time.

Drug costs also eat into the limited savings of the elderly, dragging many into bankruptcy or poverty. As reported at the conference by Peter Bach of the Memorial Sloan Kettering Cancer Center, high costs drive away many patients who would benefit from the medications, thus leading to worse health care conditions down the line.

Similar problems can be seen internationally as well.

Petrie-Flom drew together a stellar roster of speakers and panelists for its one-day conference. However, when one shakes out all the statistics and recommendations, the experts turn out to lack answers. Their suggestions look like tinkering around the edges, just as the federal government did over the past year with new rules such as citing prices in drug ads and tweaking the Medicare Part D reimbursement formulas. Thus, I will not tediously cover all the discussions at the conference. I will instead raise some key issues while tapping into these discussions for fodder.

The loudest statement at the conference was the silence of the pharma industry. Representatives of everyone you could imagine with skin in this game appeared on the podium–insurers, clinicians, pharmacy benefit managers, the finance industry, regulators, patent activists, think tanks, and of course lawyers–with one glaring exception: drug manufacturers. I’m sure these companies were invited. But the only biopharmaceutical firm to show up was Gilead Sciences, and the talk given by Amy Flood, senior vice president of public affairs, was not about normal drug development but about the company’s commendable efforts to disseminate an HIV drug through sub-Sahara Afica. Given the intense political, social, and geographic contention over AIDS, her inspiring story had little in the way of models and lessons to offer mainstream drug development. I will cover it later in the section ‘What non-profits can teach us.”

Failure by the vast bulk of the pharma industry to take up the sterling opportunity represented by this conference to present their point of view, to me, comes across as an admission of guilt. Why can’t they face questions from an educated public?

The oncoming sucker punch

A couple days before the conference, Stat published a heart-warming human interest story about a six-year old being treated successfully for a debilitating rare condition, Batten disease. Rather than giving in to genetic fate, the parents pulled together funding and doctors from around the country, pushed the experimental treatment through an extremely fast-track FDA approval, and saw positive results within a year.

The tears tend to dry from one’s eyes–or to flow for different reasons–when one reads the means used to achieve this miracle. The child’s mother is a marketing professional who raised nearly three million dollars through crowdfunding. An article in the November/December issue of MIT Tech Review describes six other families who raised money for personalized genetic treatments. Another article in the same issue–which is devoted to big data and genetic research in medicine–discusses personalized vaccines against cancers, while a third lays out the expenses of in vitro genetic testing. This is not a course of action open to poor, marginalized, uneducated people. Nor is such money likely to turn up for every orphan disease suffered somewhere in the world.

I hope that this six-year-old recovers. And I hope the three-million-dollar research produces advances in gene science that redound to the benefit of other sufferers. But we must all consider how much society can spend on the way to an envisioned utopia where cures are available to all for previously untreatable conditions. As conference speakers pointed out, genetic treatments assume an “N of 1” where each patient gets a unique regimen. This doesn’t scale at all, and certainly doesn’t fit the hoary old pharmaceutical paradigm of giving a monopoly over a treatment for a decade or so in exchange for low-cost generic imitations for all eternity afterward.

Yet government needs to keep funding biotech research, and creating a positive regulatory environment when venture capitalists and other investors will fund the research. Joe Grogan of the Office of Management and Budget, keynoting at the conference, claimed that Germany used to have the pre-eminent biotech industry and let it shrivel up through poor policies. In the same way, biotech could leave the United States for some other country that proves welcoming, probably China.

Dueling models

Some panelists enthusiastically promoted what they openly and officially called Willingness To Pay (WTP) or “what the market will bear” pricing, but which I call “stick it to ’em” pricing. Others called for the price controls that are found in almost every developed country outside the U.S. Various schemes being promoted under the umbrella of “value-based pricing” were generally rejected, probably because they would allow the companies to inflate their prices. However, Jami Taylor of Stanton Park Capital suggested that modern data collection and analytics could support micropricing, matching payment to the outcome for each patient.

Interestingly, nobody believed that drug prices should reflect the costs of producing them. But everybody understood that drug producers must be adequately reimbursed. That is why people from many different perspectives came out in opposition to “charity” and “compassionate” discounts or rebates offered by many pharma companies, sometimes reaching 10% of their total expenditures. In a typical sequence of events, a company enjoying a breakthrough for a serious condition announces some enormous price in the tens or hundreds of thousands of dollars. After public outcry (or to ward off such outcry) they start awarding deep discounts or rebates.

Why are discounts and rebates poor policy? First, they bind the recipients to dependence on the company. This is why, according to Annette Gaudino of the Treatment Action Group, Médecins Sans Frontières rejected a donation from a manufacture of a vaccine.

More subtly, high list prices set a bar for future prices. They allow the companies to jack up prices for brand-name drugs by double digits each year (as shown in a chart by Surya Singh of CVS Health) and to introduce new drugs at inflated prices–only to take off the edge through more discounts and rebates.

Grogan would like Europeans to pay higher prices, following the common perception that US consumers are subsidizing the rest of the world. But other speakers contended that Europeans offer fair compensation that can keep drug companies sustainable. A recent administration proposal to force manufacturers to match foreign drug prices seems to take the same attitude.

Aaron Kesselheim of Harvard Medical School participated in a study that demonstrated the robustness of European price controls in a clever manner. He and colleagues simply examined which drugs were withdrawn from the German market by manufacturers who didn’t want to undergo their rigorous price-setting regime, run by the Institute for Quality and Efficiency in Health Care (IQWiG). The 20% of drugs that were withdrawn were those demonstrated to be ineffective or to be no better than lower-priced alternatives.

Gaudino also tried to slay the opponents of price controls with an onslaught of statistics. She cited a JAMA study finding that bringing a cancer drug to market costs well under one million dollars, less than half of the billions often cited. The non-profit Drugs for Neglected Diseases initiative (DNDi) can produce a new medicine for a total cost of just 110 to 170 million dollars. And the average profit for pharma companies has stayed level at around 20% for decades, far above most industries.

With all these endorsements for price controls, the shadow of possible negative effects on innovation hover over them. In the next part of this article, I’ll examine technical advances that might lower costs.

Nurses and Patient Loads: The Solution Lies in Process Change, Not Maximums

Posted on November 1, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

Shortages of clinical staff plague communities around the world. Even my state of Massachusetts, a medical Mecca, has a shocking dearth of professionals in mental health. Health care reformers understand that shortages much be addressed through a careful and deep investigation into the hospital and clinic processes and practices. Streamlining processes through data analytics and the deft application of new technologies for monitoring and recording information will probably help.

Nurses probably experience the crunch of patient loads more than other staff. Unfortunately, some of them try to force a quick fix on their institutions through mandatory maximums. They ignore process, ignore holistic systems thinking, and ignore the potential of technology. Massachusetts is facing just such an ill-planned effort right now in a ballot question that would fix arbitrary patient loads. The public is being asked to regulate an area that can’t possibly understand. (The inscrutable text of this ballot question, number 1 on the ballot, is available about one-quarter of the way down this web page.) But Massachusetts was not the first to face this choice, and will probably not be the last.

In 2003, California passed limits on patient loads that are somewhat of a model for the Massachusetts law, and whose effects are hotly debated. Texas apparently considered a similar law, but I assume it went nowhere because I could find no other reference to it. Massachusetts has a law applying narrowly to emergency rooms, and every state has regulations for nursing homes.

Nurses don’t have it easy; that’s clear. But the solutions must be systemic. Opponents of Massachusetts ballot question 1 point to all kinds of negative effects that the proponents refuse to consider, such as the loss of non-nursing staff who are crucial to helping the nurses get their jobs done. The basic problem is that hospitals and other facilities are not making use of the computing advances, and related process improvements, available in this year 2018.

Health care giant Kaiser Permanente found that clinicians were spending 15 to 40 percent of their doing “hunting and gathering” for supplies before the company optimized its supply chains. The Boston Globe cites numerous management techniques that free up clinicians’ time, some right in Boston. A 2011 NIH report found that nurses spend only 37% of their time taking direct care of patients. Of course, other activities such as administration and documentation are important, but they are begging for process improvement. Partners Health Care has embarked on a large-scale effort to automate repetitive, “soul-crushing” work, and have found that staff are much happier and are spending more time using the skills they were trained to use in handling people issues. Currently, the effort affects HR, finance, and operations. I’m sure nursing would turn up opportunities for improvement when it comes their turn.

We shouldn’t have to spend 35% of nurses’ time on documentation, using systems that are notoriously inefficient and poorly automated. A recent survey showed that most doctors believe that automating common tasks such as documentation could improve clinicians’ efficiency. Nurses use the same systems, so their workloads could probably be reduced through similar improvements in technology.

Some nurses tell me, “Much of our job involves a human touch; it can’t be automated.” The NIH study shows that plenty of tasks that are amenable to computerization, and doing so will give nurses more time to apply their human touch–or as health care workers like to say, “work at the top of their license.”

The proponents of the Massachusetts ballot question count on a knee-jerk distrust of corporations (or at least of large health-care institutions). They have succeeded in winning over many people who call themselves political “progressives,” but a large segment of the Massachusetts public–according to polls, a slightly larger segment–intrinsically sense the ballot question’s flaws, so the polls are running against its passing.

We cannot improve health care and reduce costs if institutions take the status quo for granted. Voting “yes” on question 1 in Massachusetts would accept and perpetuate the assumptions behind our nursing practices. It’s hard to accept that profound systemic problems will take time and data to ameliorate, but the sooner we face that realization, the better we can deal with our clinical staffing problems.

Software Marks Advances at the Connected Health Conference (Part 2 of 2)

Posted on October 31, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The first part of this article focused on FDA precertification of apps and the state of interoperability. This part covers other interesting topics at the Connected Health conference.

Presentation at Connected Health Conference

Presentation at Connected Health Conference

Patient engagement

A wonderful view upon the value of collecting patient data was provided by Steve Van, a patient champion who has used intensive examination of vital signs and behavioral data to improve his diabetic condition. He said that the doctor understands the data and the patient knows how he feels, but without laying the data out, they tend to talk past each other. Explicit data on vital signs and behavior moves them from monologue to dialogue. George Savage, MD, co-founder and CMO of Proteus, described the value of data as “closing the loop”–in other words, providing immediate and accurate information back to the patient about the effects of his behavior.

I also gained an interesting perspective from Gregory Makoul, founder and CEO of PatientWisdom, a company that collects a different kind of data from patients over mobile devices. The goal of PatientWisdom is to focus questions and make sure they have an impact: the questionnaire asks patients to share “stories” about themselves, their health, and their care (e.g., goals and feelings) before a doctor visit. A one-screen summary is then provided to clinical staff via the EHR. The key to high adoption is that they don’t “drill” the patient over things such as medications taken, allergies, etc. They focus instead on distilling open-ended responses about what matters to patients as people, which patients like and providers also value.

Sam Margolis, VP of client strategy and growth at Cantina, saw several aspects of the user experience (UX) as the main hurdle for health IT companies. This focus was reasonable, given that Cantina combines strengths in design and development. Margolis said that companies find it hard to make their interfaces simple and to integrate into the environments where their products operate. He pointed out that health care involves complex environments with many considerations. He also said they should be thinking holistically and design a service, not just a product–a theme I have seen across modern business in general, where companies are striving to engage customers over long periods of time, not just sell isolated objects.

Phil Marshall, MD, co-founder and chief product officer of Conversa Health, described how they offer a chatbot to patients discharged from one partnering hospital, in pursuit of the universal goal by US hospitals to avoid penalties from Medicare for readmissions. The app asks the patient for information about her condition and applies the same standards the hospital uses when its staff evaluates discharged patients. Marshall said that the standards make the chatbot highly accurate, and is tuned regularly. It is also popular: 80 percent of the patients offered the app use it, and 97 percent of these say it is helpful. The chat is tailored to each patient. In addition to relieving the staff of a routine task, the hospital found that the app reduces variation among outcomes among physicians, because the chatbot will ask for information they might forget.

Jay V. Patel, Clinical Transformation Officer at Seniorlink, described a care management program that balances technology and the human touch to help caregivers of people with dementia. Called VOICE (Vital Outcomes Inspired by Caregiver Engagement) Dementia Care, the program connects a coach to family caregivers and their care teams through Vela, Seniorlink’s collaboration platform. The VOICE DC program reduced ER visits by 51 percent and hospitalizations by 18 percent in the six-month pilot. It was also good for caregivers, reducing their stress and increasing their confidence.

Despite the name, VOICE DC is text-based (with video content) rather than voice-based. An example of the advances in voice interfaces was provided at this conference by Boston Children’s Hospital. Elizabeth Kidder, manager of their digital health accelerator, reported using voice interfaces to let patients ask common questions, such as when to get vaccinations and whether an illness was bad enough to keep children home from school and day care. Another non-voice app they use is a game that identifies early whether a child has a risk of dyslexia. Starting treatment before the children are old enough to learn reading in school can greatly increase success.

Nathan Treloar, president of Orbita, reported that at a recent conference on voice interfaces, participants in a hackathon found nine use cases for them in health.

Pattie Maes of the MIT Media Lab–one of the most celebrated research institutions in digital innovation–envisions using devices to strengthen the very skills that our devices are now blamed for weakening, such as how to concentrate. Of course, she warned, there is a danger that users will become dependent on the device while using it for such skills.

Working at the top of one’s license

I heard that appealing phrase from Christine Goscila, a family nurse practitioner at Massachusetts General Hospital Revere. She was describing how an app makes it easier for nurses to collect data from remote patients and spend more time on patient care. This shift from routine tasks to high-level interactions is a major part of the promise of connected health.

I heard a similar goal from Gregory Pelton, MD, CMO of ICmed, one of the many companies providing an integrated messaging platform for patients, clinicians, and family caregivers. Pelton talks of handling problems at the lowest possible level. In particular, the doctor is relieved of entering data because other team members can do it. Furthermore, messages can prepare the patient for a visit, rendering him more informed and better able to make decisions.

Clinical trials get smarter

While most health IT and connected health practitioners focus on the doctor/patient interaction and health in the community, the biggest contribution connected health might make to cost-cutting may come from its use by pharmaceutical companies. As we watch the astounding rise in drug costs–caused by a range of factors I will cover in a later article, but only partly by deliberate overcharging–we could benefit from anything that makes research and clinical trials more efficient.

MITRE, a non-profit that began in the defense industry but recently has created a lot of open source tools and standards for health care, presented their Synthea platform, offering synthetic data for researchers. The idea behind synthetic data is that, when you handle a large data set, you don’t need to know that a particular patient has congestive heart failure, is in his sixties, and weighs 225 pounds. Even if the data is deidentified, giving information about each patient raises risks of reidentification. All you need to know is a collection of facts about diagnoses, age, weights, etc. that match a typical real patient population. If generated using rigorous statistical algorithms, fake data in large quantities can be perfectly usable for research purposes. Synthea includes data on health care costs as well as patients, and is used for FHIR connectathons, education, the free SMART Health IT Sandbox, and many other purposes.

Telemedicine

Payers are gradually adapting their reimbursements to telemedicine. The simplest change is just to pay for a video call as they would pay for an office visit, but this does not exploit the potential for connected health to create long-range, continuous interactions between doctor, patient, and other staff. But many current telemedicine services work outside the insurance system, simply charging patients for visits. This up-front payment obviously limits the ability of these services to reach most of the population.

The uncertainties, as well as the potential, of this evolving market are illustrated by the business model chosen by American Telephysicians, which goes so far as to recruit patients internationally, such as from Pakistan and Dubai, to create a telemedicine market for U.S. specialists. They will be starting services in some American communities soon, though. Taking advantage of the ubiquity of mobil devices, they extend virtual visits with online patient records and a marketplace for pharmaceuticals, labs, and radiology. Waqas Ahmed, MD, founder and CEO, says: “ATP is addressing global health care problems that include inaccessibility of primary, specialty, and high-quality healthcare services, lack of price transparency, substandard patient education, escalating costs and affordability, a lack of healthcare integration, and fragmentation along the continuum of care.”

The network is the treatment center

We were honored with a keynote from FCC chair Ajit Pai, who achieved notoriety recently in the contentious “net neutrality” debate and was highlighted in WIRED for his position. Pai is not the most famous FCC chair, however; that honor goes to Newton Minow, who as chair from 1961 to 1963 called television a “vast wasteland.” More recently, Michael Powell (who became chair in 2001, before the confounding term “net neutrality” was invented) garnered a lot of attention for changing Internet regulations. Newton Minow, by the way, is still on the scene. I heard him talk recently at a different conference, and Pai mentioned talking to Minow about Internet access.

Pai has made expansion of Internet access his key issue (it was mentioned in the WIRED article) and talked about the medical benefits of bringing fast, continuous access to rural areas. His talk fit well with the focus many companies at the Connected Health conference placed on telemedicine. But Pai did not vaunt competition or innovation as a solution to reaching rural areas. Instead, he seemed happy with the current oligopoly that characterizes Internet access in most areas, and promoted an increase in funding to get them to do more of what they’re now doing (slowly).

The next day, Nancy Green of Verizon offered a related suggestion that 5G wireless will make batteries in devices last longer. This is not intuitive, but I think can be justified by the decrease in the time it will take for devices to communicate with the cloud, decreasing in turn the drain on the batteries.

Devices that were just cool

One device I liked at Connected Health coll was the Eko stethoscope, which sends EKG data to a computer for display. Patients will soon be able to use Eko devices to view their own EKGs, along with interpretations that help non-specialists make sense of the results. Of course, the results are also sent to the patients’ doctors.

Another device is a smart pillbox by CUEMED that doubles as a voice-interactive health assistant, HEXIS. Many companies make smart pill boxes that keep track of whether you open them, and flash or speak up to remind you when it’s time to take the pills. (Non-compliance with prescription medications is rampant.) HEXIS is a more advanced innovation that incorporates Alexa-like voice interactivity with the user and can connect to other medical devices and wearables such as Apple Watch and blood pressure monitors. The device uses the data and vital signs to motivate the user, and provides suggestions for the user to feel better. Another nice feature is that if you’re going out, you can remove one day’s meds and take them with you, while the device continues to do its job of reminding and tracking.

I couldn’t get to every valuable session at the Connected Health conference, or cover every speaker I heard. However, the conference seems to be achieving its goals of bringing together innovators and of prodding the health care industry toward the effective use of technology.

Software Marks Advances at the Connected Health Conference (Part 1 of 2)

Posted on October 29, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The precepts of connected health were laid out years ago, and merely get updated with nuances and technological advances at each year’s Connected Health conference. The ideal of connected health combines matching the insights of analytics with the real-life concerns of patients; monitoring people in everyday settings through devices that communicate back to clinicians and other caregivers; and using automation to free up doctors to better carry out human contact. Pilots and deployments are being carried out successfully in scattered places, while in others connected health languishes while waiting for the slow adoption of value-based payments.

Because I have written at length about the Connected Health conference in 2015, 2016, and 2017, I will focus this article on recent trends I ran into at this year’s conference. Key themes include precertification at the FDA, the state of interoperability (which is poor), and patient engagement.

Exhibition floor at Connected Health conference

Exhibition floor at Connected Health conference

Precertification: the status of streamlining approval for medical software

One of the ongoing challenges in the progress of patient involvement and connected health is the approval of software for diagnosis and treatment. Traditionally, the FDA regulated software and hardware together in all devices used in medicine, requiring rigorous demonstrations of safety and efficacy in a manner similar to drugs. This was reasonable until recently, because anything that the doctor gives to the patient needs to be carefully checked. Otherwise, insurers can waste a lot of money on treatments that don’t work, and patients can even be harmed.

But more and more software is offered on generic computers or mobile devices, not specialized medical equipment. And the techniques used to develop the software inherit the “move fast and break things” mentality notoriously popular in Silicon Valley. (The phrase was supposedly a Facebook company motto.) Software can be updated several times a day. Although A/B testing (an interesting parallel to randomized controlled trials) might be employed to see what is popular with users, quality control is done in completely different ways. Modern software tends to rely for safety and quality on unit tests (which make sure individual features work as expected), regression tests (which look for things that no longer work they way they should), continuous integration (which forces testing to run each time a change is submitted to the central repository), and a battery of other techniques that bear such names as static testing, dynamic testing, and fuzz testing. Security testing is yet another source of reliability, using techniques such as penetration testing that may be automated or manual. (Medical devices, which are notoriously insecure, might benefit from an updated development model.

The FDA has realized that reliable software can be developed within the Silicon Valley model, so long as rigor and integrity are respected. Thus, it has started a Pre-Cert Pilot Program that works with nine brave vendors to find guidelines the FDA can apply in the future to other software developers.

Representatives of four vendors reported at the Connected Health conference that the pilot is going quite well, with none of the contentious and adversarial atmosphere that characterizes the interactions between the FDA with most device manufacturers. Every step of the software process is available for discussion and checking, and the inquiries go quite deep. All participants are acutely aware of the risk–cited by critics of the program–that it will end up giving vendors too much leeway and leaving the public open to risks. The participants are committed to closing loopholes and making sure everyone can trust the resulting guidelines.

The critical importance of open source software became clear in the report of the single open source vendor who is participating in the pilot: Tidepool. Because it is open source, according to CEO Howard Look, Tidepool was willing to show its code as well as its software development practices to independent experts using multiple evaluation assessment methods, including a “peer appraisal” by fellow precert participants Verily and Pear Therapeutics. One other test appraisal (CMMI, using external auditors) was done by both Tidepool and Johnson & Johnson; no other participants did a test appraisal. Thus, if the FDA comes out with new guidelines that stimulate a tremendous development of new software for medical use, we can thank open source.

Making devices first-class players in health care

Several exhibitors at the conference were consulting firms who provide specific services to start-ups and other vendors trying to bring products to market. I asked a couple of these consultants what they saw as the major problems their clients face. Marcus Fontaine, president of Impresiv Health, said their biggest problem is the availability of data, particularly because of a lack of interoperable data exchange. I wanted to exclaim, “Still?”

Joseph Kvedar, MD, who chairs the Connected Health conference, spoke of a new mobile app developed by his organization, Partners Connected Health, to bring device data into their EHR. This greatly improves the collection of data and guarantees accuracy, because patients no longer have to manually enter vital signs or other information. In addition to serving Partners in improving patient care, the data can be used for research and public health. In developing this app, Partners depended heavily for interoperable data exchange on work by Validic, the most prominent company in the device interoperability space, and one that I have profiled and whose evolution I have followed.

Ideally, each device could communicate directly with the EHR. Why would Partners Connected Health invest heavily in creating a special app as an intermediary? Kvedar cited several reasons. First, each device currently offers its own app as a user interface, and users with multiple devices get confused and annoyed by the proliferation of apps. Second, many devices are not designed to communicate cleanly with EHRs. Finally, the way networks are set up, communicating would require a separate cellular connection and SIM card for each device, raising costs.

A similar effort is pursued by Indie Health, trying to solve the problem of data access by making it easy to create Bluetooth connections between devices and mobile phones using a variety of Bluetooth, IEEE, Continua, and other standards.

The CEO of Validic, Drew Schiller, spoke on another panel about maximizing the value of patient-generated data. He pointed out that Validic, as an intermediary for a huge number of devices and health care providers, possesses a correspondingly huge data set on how patients are using the devices, and in particular when they stop using the devices. I assume that Validic does not preserve the data generated by the devices, such as blood pressure or steps taken–at least, Schiller did not say they have that data, and it would be intrusive to collect it. However, the metadata they do collect can be very useful in designing interactions with patients. He also talked about the value of what he dubs “invisible health care,” where behavior change and other constructive uses of data can flow easily from the data.

Barry Reinhold, president and CTO of Lamprey Networks, was manning the Continua booth when I came by. Continua defines standard for devices used in the home, in nursing faciliies, and in other places outside the hospital. This effort should be open source, supported by fees by all affected stakeholders (hospitals, device manufacturers, etc.). But open source is spurned by the health care field, so Continua does the work as a private company. Reinhold told me that device manufacturers rarely contract with Continua, which I treat as a sign that device manufacturers value data silos as a business model. Instead, Continua contracts come from the institutions that desperately need access to the data, such as nursing facilities. Continua does the best it can to exploit existing standards, including the “continuing data” profile from FHIR.

Other speakers at the conference, including Andrew Hayek, CEO of OptumHealth, confirmed Reinhold’s observation that interoperability still lags among devices and EHRs. And Schiller of Validic admitted that in order to get data from some devices into a health system, the patient has to take a photo of the device’s screen. Validic not only developed an app to process the photo, but patented it–a somewhat odd indication that they consider it a major contribution to health care.

Tasha van Es and Claire Huber of Redox, a company focused on healthcare interoperability and data integration, said that they are eager to work with FHIR, and that it’s a major part of their platform, but they think it has to develop more before being ready for widespread use. This made me worry about recent calls by health IT specialists for the ONC, CMS, and FDA to make FHIR a requirement.

It was a pleasure to reconnect at the conference with goinvo, which creates open source health care software on a contract basis, but offers much of it under a free license.

A non-profit named Xcertia also works on standards in health care. Backed by the American Medical Association, American Heart Association, DHX Group, and HIMSS, they focus on security, privacy, and usability. Although they don’t take on certification, they design their written standards so that other organizations can offer certification, and a law considered in California would mandate the use of their standards. The guidelines have just been released for public comment.

The second section of this article covers patient engagement and other topics of interest that turned up at the conference.

Open Source Software and the Path to EHR Heaven (Part 2 of 2)

Posted on September 20, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The previous segment of this article explained the challenges faced by health care organizations and suggested two ways they could be solved through free and open source software. We’ll finish the exploration in this segment of the article.

Situational awareness would reduce alert fatigue and catch errors

Difficult EHR interfaces are probably the second most frustrating aspect of being a doctor today: the first prize goes to the EHR’s inability to understand and adapt to the clinician’s workflow and environment. This is why the workplace redounds with beeps and belches from EHRs all day, causing alert fatigue and drowning out truly serious notifications. Stupid EHRs have an even subtler and often overlooked effect: when regulators or administrators require data for quality or public health purposes, the EHR is often “upgraded” with an extra field that the doctor has to fill in manually, instead of doing what computers do best and automatically replicating data that is already in the record. When doctors complain about the time they waste in the EHR, they often blame the regulators or the interface instead of placing their finger on the true culprit, which is the lack of awareness in the EHR.

Open source can ease these problems in several ways. First, the customizability outlined in the first section of this article allows savvy users to adapt it to their situations. Second, the interoperability from the previous section makes it easier to feed in information from other parts of the hospital or patient environment, and to hook in analytics that make sense of that information.

Enhancements from outside sources could be plugged in

The modularity of open source makes it easier to offer open platforms. This could lead to marketplaces for EHR enhancements, a long-time goal of the open SMART standard. Certainly, there would have to be controls for the sake of safety: an administrator, for instance, could limit downloads to carefully vetted software packages.

At best, storage and interface in an EHR would be decoupled in separate modules. Experts at storage could optimize it to improve access time and develop new options, such as new types of filtering. At the same time, developers could suggest new interfaces so that users can have any type of dashboard, alerting system, data entry forms, or other access they want.

Bugs could be fixed expeditiously

Customers of proprietary software remain at the mercy of the vendors. I worked in one computer company that depended on a very subtle feature from our supplier that turned out not to work as advertised. Our niche market, real-time computing, needed that feature to achieve the performance we promised customers, but it turned out that no other company needed it. The supplier admitted the feature was broken but told us point-blank that they had no plans to fix it. Our product failed in the marketplace, for that reason along with others.

Other software users suffer because proprietary vendors shift their market focus or for other reasons–even going out of business.

Free and open source software never ossifies, so long as users want it. Anyone can hire a developer to fix a bug. Furthermore, the company fixing it usually feeds the fix back into the core project because they want it to be propagated to future versions of the software. Thus, the fixes are tested, hardened, and offered to all users.

What free and open source tools are available?

Numerous free and open source EHRs have been developed, and some are in widespread use. Most famously is VistA, the software created at the Department of Veterans Affairs, and used also by the Indian Health Service and other government agencies, has a community chaperone and has been adopted by the country of Jordan. VistA was considered by the Department of Defense as well, but ultimately rejected because the department didn’t want to invest in adding some missing features.

Another free software EHR, OpenMRS, supports health care in Kenya, Haiti, and elsewhere. OpenEMR is also deployed internationally.

What free and open source software has accomplished in these settings is just a hint of what it can do for health care across the board. The problem holding back open source is simple neglect: as VistA’s experience with the DoD showed, institutions are unwilling to support open source, even through they will pay 10 or 100 times as much on substandard proprietary software. Open Health Tools, covered in the article I just linked to, is one of several organizations that shriveled up and disappeared for lack of support. Some organizations gladly hop on for a free ride, using the software without contributing either funds or code. Others just ignore open source software, even though that means their own death: three hospitals have recently declared bankruptcy after installing proprietary EHRs. Although the article focuses on the up-front costs of installing the EHRs, I believe the real fatal blow was the inability of the EHRs to support efficient, streamlined health care services.

We need open source EHRs not just to reduce health care costs, but to transform health. But first, we need a vision of EHR heaven. I hope this article has taken us at least into the clouds.

Open Source Software and the Path to EHR Heaven (Part 1 of 2)

Posted on September 19, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

Do you feel your electronic health record (EHR) is heaven or hell? The vast majority of clinicians–and many patients, too, who interact with the EHR through a web portal–see it as the latter. In this article, I’ll describe an EHR heaven and how free and open source software can contribute to it. But first an old joke (which I have adapted slightly).

A salesman for an EHR vendor dies and goes before the Pearly Gates. Saint Peter asks him, “Would you like to go to heaven or hell?”

Surprised, the salesman says, “I didn’t know I had a choice.”

Saint Peter suggests, “How about this. We’ll show you heaven and hell, and then you can decide.”

“Sounds fair,” says the EHR salesman.

First they take him to heaven. People wearing white robes are strumming harps and singing hymns, and it goes on for a long time, till they take him away.

Next they take him to hell. And it’s really cool! People are clinking wine glasses together and chatting about amusing topics around the pool.

When the EHR salesman gets back to the Pearly Gates, he says to Saint Peter, “You know, this sounds really strange, but I choose hell.”

Immediately comes a clap of thunder. The salesman is in a fiery pit being prodded with pitchforks by dreadful demons.

“Wait!” he cries out. “This is not the hell I saw!”

One of the demons answers, “They must have shown you the demo.”

Most hospitals and clinicians are currently in EHR hell–one they have freely chosen, and one paid for partly by government Meaningful Use reimbursements. So we all know what EHR hell look like. What would EHR heaven be? And how does free and open source software enable it? The following sections of this article list the traits I think clinicians would like to see.

Interfaces could be easily replaced and customized

The greatest achievement of the open source movement, in my opinion, has been to strike an ideal balance between “let a hundred flowers bloom” experimentation and choosing the best option to advance the field. A healthy open source project encourages branching, which lets any individual or team with the required expertise change a product to their heart’s content. Users can then try out different versions, and a central committee vets the changes to decide which version is most robust.

Furthermore, modularization on various levels (programming modules, hooks, compile-time options, configuration tools) allows multiple versions to co-exist, each user choosing the options right for their environment. Open source software tends to be modular for several reasons, notably because it is developed by many different individuals and teams who want control over their small parts of the system.

With easy customization, a hospital or clinic can mandate that certain items be highlighted and that safe workflow rules be followed when entering or retrieving data. But the institution can also offer leeway for individual clinicians and patients to arrange a dashboard, color scheme, or other aspect of the environment to their liking.

Many of the enablers for this kind of agile, user-friendly programming are technical. Modularity is built into programming languages, while branching is standard in version control systems. So why can’t proprietary vendors do what open source communities routinely do? A few actually do, but most are constrained in ways that prevent such flexibility, especially in electronic health records:

  • Most vendors are dragging out the lifetime of nearly 40-year old technology, with brittle languages and tools that put insurmountable barriers in the way of agile work styles. They are also stuck with monolithic systems instead of modular ones.
  • The vendors’ business model depends on this monolithic control. To unbundle components, allow mix-and-match installations, and allow third parties to plug in new features would challenge the prices they charge.
  • The vendors are fundamentally unprepared for empowered users. They may vet features with clinically trained consultants and do market research, but handling power over the system to users is not in their DNA.

Data could be exchanged in a standard format without complex transformations

Data sharing is the lifeblood of modern computing; you can’t get much done on a single computer anymore. Data sharing lies behind new technologies ranging from the Internet of Things to real-time ad generation (the reason you’ll see a link to an article about “Fourteen celebrities who passed out drunk in public” when you’re trying to read a serious article about health IT). But it’s so rare in health care–where it’s uniquely known as “interoperability”–that every year, reformers call it the most critical goal for health IT, and the Office of the National Coordinator has repeatedly narrowed its Meaningful Use and related criteria to emphasize interoperability.

Open source software can share data with other systems as a matter of course. Data formats are simple, often text-based, and defined in the code in easy-to-find ways. Open source programmers, freed from the pressures on proprietary developers to reinvent wheels and set themselves apart from competitors, like to copy existing data formats. As a stark example of open source’s advantages, consider the most recent version of the Open Document Format, used by LibreOffice and other office suites. It defines an entire office suite in 104 pages. How big is the standards document for the Microsoft OOXML format, offering roughly equivalent functionality? Currently, 6,755 pages–and many observers say even that is incomplete. In short, open source is consistently the right choice for data exchange.

What would the adoption of open source do to improve health care, given that it would solve the interoperability problem? Records could be stored in the cloud–hopefully under patient control–and released to any facility treating the patient. Research would blossom, and researchers could share data as allowed by patients. Analytical services could be plugged in to produce new insights about disease and treatment from the records of millions of people. Perhaps interoperability could also contribute to solving the notorious patient matching problem–but that’s a complicated issue that I have discussed elsewhere, touching on privacy issues and user control outside the scope of this article.

The next segment of this article will list three more benefits of free and open source software, along with an assessment of its current and future prospects.

Lumeon Offers a Step Toward Usable Device Data in Health Care

Posted on August 8, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The health care field floats on oceans of patient data, but like the real oceans on our planet, patient data is polluted. Trying to ground evidence-based medicine on billing data is an exercise in frustration. Clinical data is hard to get access to, and has its own limitations. For instance, it is collected only when a patient visits the clinic or hospital. The FDA recently put 100 million dollars in its budget to get patient data from electronic health records (which the commissioner called “real-world experience”).

One of the paths toward better data for research and treatment lies in the data from medical devices: it’s plentiful, detailed, and accurate. But device data has mountains to climb before researchers and clinicians can use it: getting this data in the first place, normalizing and standardizing it, and integrating it with the systems used for analysis and treatment. That’s what excites me about a recent new direction taken by Lumeon, a platform for workflow management and treatment coordination in health care.

I covered Lumeon’s platform a few months ago. The company already lays out an enticing display of tools for clinicians, along with EHR integration. What’s new is the addition of medical devices, an enhancement that required nine months of working with medical device manufacturers. Recently I had another chance to talk to Rick Halton, Vice President of Marketing and Product for Lumeon.

Along with the measurements provided by devices, Lumeon has tools for patient engagement and the measurement of outcomes. These outcomes go beyond simple quantitative scores such as limb rotation. Lumeon creates for each patient a patient-specific functional score (PSFS). For one patient, it may be whether he can play outside with his kids. For another, it’s whether she can they go back to work, and for another, how far she can walk.

Lumeon asks, how can a device be used in a patient journey? It uses the routine information to help provide consistent care throughout this journey pathway, and measures outcomes throughout to generate feedback that promotes better long-term outcomes.

Device data is currently stored in a Lumeon platform that may be on the clinician’s site or in the cloud. Using an API, Lumeon’s output can be embedded within an EHR (they currently do this with Epic) so that the output can be displayed as part of the EHR display, and the clinician doesn’t even have to know that the results are being generated outside the EHR. In the future, the data may be integrated directly into the EHR. However, Lumeon’s direct customers are the providers, not the EHR vendors.

Data from devices was popular among providers at first for discharge planning and other narrow applications. Lumeon’s device integration is now getting more attention from providers who are experiencing a squeeze on reimbursements, a growing alertness among payers for outcomes, and a slow move in the industry toward fee-for-value. One leading device manufacturer is already using Lumeon for better treatment of cardiovascular care, bariatric surgery, and diabetes. Other applications include chronic disease, perioperative care (readiness for the OR and enhanced recovery), the digital patient experience on the web or in an app, and the patient centered medical home.

If Lumeon can turn device data into better treatment, other clinical institutions and health care platforms should be able to do so as well. It’s time for health care to enter the 21st century and use the Internet of Things (or Internet of Healthy Things, as termed by Dr. Joseph Kvedar) for the benefit of patients.

Barriers to Patient-Centered Research Aired at Harvard Symposium

Posted on July 2, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

While writing about health IT, I routinely find myself at legal conferences. Regulatory issues about patient privacy and safety arise everywhere health IT tries to have an impact, so people promoting change must keep in touch with policy-makers and lawyers in the health care area.

Thus I went this past Friday to Harvard for a one-day symposium, “Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight,” sponsored by Harvard’s Petrie-Flom Center.

Audience at Patient-Centered conference at Harvard

*Audience at Patient-Centered conference at Harvard

Involving patients in patient care is a surprisingly recent concern. There was a time when doctors made all the decisions, delivering them as if they had come directly from the entrails of an oracular temple. Visitors were severely limited at hospitals, because family members just got in the way of the professional staff. And although the attitude toward engaging patients and their families has softened somewhat in health care, rigid boundaries still exist in research.

As project leader Joel Weissman pointed out at the beginning of the Petrie-Flom conference, patient rights weren’t considered by health care professionals until the 1980s, as outgrowths of the civil rights and women’s rights movements. Patient engagement languished still longer. It received a legal toehold in the 2010 Affordable Care Act, which set up the Patient-Centered Outcomes Research Institute. Although more researchers over the past eight years have warmed to the idea of engaging with patients in other ways than subjects of clinical trials, the Petrie-Flom conference highlighted how little progress we have made.

In a “nothing about us without us” era, it would seem odd to an outsider like me that patients should be excluded from the roles now being tentatively offered:

  • Joining the research team in some capacity
  • Recruiting subjects for trials and engaging the patient community
  • Helping disseminate results
  • Acting as consultants in some other way

But risks are certainly entailed by inserting non-professionals of any stripe into the research environment, so some criteria and processes need to be set up. Before filling non-traditional roles, patients should be required to undergo training in ethics, the science behind the study, and some of the methodology. There are particular risks when the patients have access to personally identifiable data. (I don’t see why this should ever be necessary, but the possibility was raised several times during the day.)

The panelists also cited conflicts of interest as a risk. Many researchers recruit engaged patients from the companies that make related drugs or other products, simply because those are easy places to recruit. This problem highlights the importance of casting a wide net and recruiting diverse populations as engaged patients. However, one could argue that merely suffering from the condition that the researchers are investigating leaves one with a conflict of interest: you want the research to produce a cure, so you may not be even-handed in your acceptance of negative results.

What spurred this conference? The Petrie-Flom Center and PCORI have spent the past academic year doing a study of patient-centered research, and recently published an article by a team led by Weissman. The center presented the results at Friday’s conference to an audience of some 80 members of the health care field and interested observers.

The study was narrow and intensive. It focused on the attitudes of those running Institutional Review Boards, which are notoriously conservative. Thus, in my opinion, the results focused on what was holding back patient-centered research rather than what was already working well. The process was quite drawn out: questionnaires sent to hundreds of medical schools, public health schools, and hospitals; six focus groups with an iterative process for evaluating recommendations; and a modified Delphi consensus process among 17 experts, including (of course) representative patients.

Respondents to the survey expressed strong support for patient-centered research, believing (at a rate of about 90%) that it would benefit patients and clinicians, as well as (at a rate of about 80%) researchers. Those IRBs who tried out patient-centered research were especially enthusiastic, likely to say that it improved the quality of research results.

But IRB heads also openly expressed confusion and frustration about the pressure to include patients in the “non-traditional” roles listed earlier. Some of their reactions were productive: for instance, large majorities of respondents called on the federal government to provide standards, guidelines, and training for patient engagement. But some of the immediate measures IRBs put in place were irrelevant and even counterproductive. For instance, some required patients to sign informed consent forms, even though these patients were not the subjects of trials and therefore had no reason to need to consent. As patient advocate Jane Perlmutter pointed out, patients in non-traditional roles don’t require protection but require training to ensure that they protect the subjects of the research.

Perlmutter emphasized the importance of financial compensation. Without it, researchers will recruit mostly unemployed patients with independent incomes. To reach out to multiple ethnic groups, age ranges, and economic strata, payment must be offered for the work performed.

Unfortunately, I didn’t see much at Friday’s conference about topics directly related to health IT, such as privacy and ownership of data. Researcher Luke Gelinas mentioned that patient-centered research is more likely to use sensors, networking, social media, and other modern technology than more traditional research, and that these raise issues of informed consent, privacy, and ownership of data.

On the whole, the Petrie-Flom researchers thought there was no need for a whole new approach. But they are working on several recommendations to improve the current situation. In summary, the takeaways I derived from the symposium include:

  • The value of patient-centered research is widely appreciated, and its benefits have been demonstrated where it has been tried.
  • However, progress implementing patient-centered research is slow.
  • Training for patients in non-traditional roles is required, but not so much as to be daunting and make it difficult to participate.
  • Researchers have not devoted enough effort to diversity.
  • Governments can offer support in typical ways, such as setting standards and funding programs.

I also predict that the growth of patient-centered research will place additional strains on IT systems. Bringing in new team members in scattered environments will require multiple systems to interact without friction. Data will need to be segmented and released carefully to just the right people. Interfaces will have to be intuitive (if such a thing exists) and easy to use without much training and without risk of errors. So the field has its work cut out.

How the Young Unity Health Score Company Handles The Dilemmas of Health IT Adoption

Posted on June 25, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

I have been talking to a young company called Unity Health Score with big plans for improving the collection and sharing of data on patients. Their 55-page business plans covers the recruitment of individuals to share health data, the storage of that data, and services to researchers, clinicians, and insurers. Along the way, Unity Health Score tussles with many problems presented by patient data.
Unity Health Score logo
The goals articulated for this company by founder Austin Jones include getting better data to researchers and insurers so they can reduce costs and find cures, improving communications and thus care coordination among clinicians and patients, and putting patients in control of their health data so they can decide where it goes. The multi-faceted business plan covers:

  • Getting permission from patients to store data in a cloud service maintained by Unity Health Score
  • Running data by the patients’ doctors to ensure accuracy
  • Giving patients control over what researchers or other data users receive their data, in exchange for monetary rewards
  • Earning revenue for the company and the patients by selling data to researchers and insurers
  • Helping insurers adjust their plans based on analysis of incoming data

The data collected is not limited to payment data or even clinical data, but could include a grab-bag of personal data, such financial and lifestyle information. All this might yield health benefits to analytics–after all, the strategy of using powerful modern deep learning is being pursued by many other health care entities. At the same time, Jones plans to ensure might higher quality data than traditional data brokers such as Acxiom.

Now let’s see what Unity Health Score has to overcome to meet its goals. These challenges are by no means unique to these energetic entrepreneurs–they define the barriers faced by institutions throughout health care, from the smallest start-up to the Centers for Medicare & Medicaid Services.

Outreach to achieve a critical mass of patients
We can talk for weeks about quality of care and modernizing cures, but everybody who works in medicine agrees that the key problem we face is indifference. Most people don’t want to think too much about their health, are apathetic when presented with options, and stubbornly resist the simplist interventions–even taking their prescribed medication. So explaining the long-term benefits of uploading data and approving its use will be an uphill journey.

Many app developers seek adoption by major institutions, such as large insurers, hospital conglomerates, and HMOs like Kaiser. This is the smoothest path toward adoption by large numbers of consumers, and Unity Health Score includes a similar plan in its business model, According to Jones, they will require the insurance company to reduce premiums based on each patient’s health score. In return, they should be able to use the data collected to save money.

Protecting patient data
Health data is probably the most sensitive information most of us produce over our lifetimes. Financial information is important to keep safe, but you can change your bank account or credit card if your financial information is leaked–you can’t change your medical history. Security and privacy guarantees are therefore crucial for patient records. Indeed, the Unity Health Score business plan cites fears of privacy as a key risk.

Although some researchers have tried distributed patient records, stored in some repository chosen by each individual, Unith Health Score opts for central storage, like most current personal health records. This not only requires great care to secure, but places on them the burden of persuading patients that the data really will be used only for purposes chosen by the patients. Too many apps and institutions play three-card Monte with privacy policies, slipping in unauthorized uses (just think back to the recent Facebook/Cambridge Analytica scandal), so Internet users have become hypervigilant.

Unity Health Score also has to sign up physicians to check data for accuracy. This, of course, should be the priority for any data entered into any medical record. Because doctors’ time is going more and more toward the frustrating task of data entry, the company offers an enticing trade-off: the patients takes the time to enter their data, and the doctor merely verifies its accuracy. Furthermore, a consolidated medical record online can be used to speed check-in times on visits and to make data sharing on mobile devices easier.

Making the data useful
Once the patients and clinicians join Unity Health Score, the company has to follow through on its promise. This is a challenge with multiple stages.

First, much of the data will be in unstructured doctors’ notes. Jones plans to use OCR, like many other health data aggregators, to extract useful information from the notes. OCR and natural language processing may indeed be more accurate than relying on doctors to meticulously fill out dozens of structured fields in a database. But there is always room for missed diagnoses or allergies, and even for misinterpretations.

Next, data sources must be harmonized. They are likely to use different units and different lexicons. Although many parts of the medical industry are trying to standardize their codings, progress is incomplete.

The notion of a single number defining one’s health is appealing, but it might be too crude for many uses. Whether you’re making actuarial predictions (when will the individual die, or have to stop working?), estimating future health care costs, or guessing where to allocate public health resources, details about conditions may be more important than an all-encompassing number. However, many purchasers of the Unity Health Score information may still find the simplicity of a single integer useful.

Making the service attractive to data purchasers
The business plan points out that most rsearch depends on large data sets. During the company’s ramp-up phase–which could take years–they just won’t have enough patients suffering from a particular condition to interest many researchers, such as pharma companies looking for subjects. However, the company can start by selling data to academic researchers, who often can accomplish a lot with a relatively small sample. Biotech, pharma, and agencies can sign up later.

Clinicians may warm to the service much more quickly. They will appreciate having easy access to patient data for emergency room visits and care coordination in general. However, this is a very common use case for patient data, and one where many competing services are vying for a business niche.

Aligning goals of stakeholders
In some ways I have saved the hardest dilemma for last. Unity Health Care is trying to tie together many sets of stakeholders–patients, doctors, marketers, researchers, insurers–and between many of these stakeholders there are irreconcilable conflicts.

For instance, insurers will want the health score to adjust their clients’ payments, charging more for sick people. This will be feared and resented by people with pre-existing conditions, who will therefore withhold their information. In some cases, such insurer practices will worsen existing disparities for the poor and underpriviledged. The Unity Health Score business plan rejects redlining, but there may be subtler practices that many observers would consider unethical. Sometimes, incentives can also be counterproductive.

Also, as the business plan points out, many companies that currently purchase health data have goals that run counter to good health: they want to sell doctors or patients products that don’t actually help, and that run up health care costs. Some purchasers are even data thieves. Unity Health Score has a superior business model here to other data brokers, because it lets the patients approve each distribution of their data. But doing so greatly narrows the range of purchasers. Hopefully, there will be enough ethical health data users to support Unity Health Score!

This is an intriguing company with a sophisticated strategy–but one with obstacles to overcome. We can all learn from the challenges they face, because many others who want to succeed in the field of health care reform will come up against those challenges.