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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.

Privacy Fears May Be Holding Back Digital Therapeutics Adoption

Posted on May 3, 2018 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Consumers were already afraid that their providers might not be able to protect the privacy of their health data. Given the daily news coverage of large data breaches and since the Facebook data scandal blew up, consumers may be even less likely try out new digital health approaches.

For example, a new study by innovation consultancy Enspektos has concluded that patients may be afraid to adopt digital therapeutics options. Many fear that the data might be compromised or the technology may subject them to unwanted personal surveillance.

Without a doubt, digital therapeutics could have a great future. Possibilities include technologies such as prescription drugs with embedded sensors tracking medication compliance, as well as mobile apps that could potentially replace drugs. However, consumers’ appetite for such innovations may be diminishing as consumer fears over data privacy grow.

The research, which was done in collaboration with Savvy Cooperative, found that one-third of respondents fear that such devices will be used to track their behavior in invasive ways or that the data might be sold to a third party without the permission. As the research authors note, it’s hard to argue that the Facebook affair has ratcheted up these concerns.

Other research by Enspektos includes some related points:

  • Machine-aided diagnosis is growing as AI, wearables and data analytics are combined to predict and treat diseases
  • The deployment of end-to-end digital services is increasing as healthcare organizations work to create comprehensive platforms that embrace a wide range of conditions

It’s worth noting that It’s not just consumers who are worried about new forms of hacker intrusions. Industry CIOs have been fretting as it’s become more common for cybercriminals to attack healthcare organizations specifically. In fact, just last month Symantec identified a group known as Orangeworm that is breaking into x-ray, MRI and other medical equipment.

If groups like Orangeworm have begun to attack medical devices — something cybersecurity experts have predicted for years — we’re looking at a new phase in the battle to protect hospital devices and data. If one cybercriminal decides to focus on healthcare specifically, it’s likely that others will as well.

It’s bad enough that people are worried about the downsides of digital therapeutics. If they really knew how insecure their overall medical data could be going forward, they might be afraid to even sign in to their portal again.

Measuring the Vital Signs of Health Care Progress at the Connected Health Conference (Part 3 of 3)

Posted on November 17, 2017 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 covered one of the crucial themes in health care today: simplifying technology’s interactions with individuals over health care. This segment finishes my coverage of this year’s Connected Health Conference with two more themes: improved data sharing and blockchains.

Keynote at Connected Health Conference

Keynote at Connected Health Conference

Improved data sharing
The third trend I’m pursuing is interoperability. If data collection is the oxygen that fuels connected health, data sharing is the trachea that brings it where it’s needed. Without interoperability, clinicians cannot aid patients in their homes, analysts cannot derive insights that inform treatments, and transitions to assisted living facilities or other environments will lead to poor care.

But the health care field is notoriously bad at data sharing. The usual explanation is that doctors want to make it hard for competitors to win away their patients. If that’s true, fee-for-value reimbursements will make them even more possessive. After all, under fee-for-value, clinicians are held accountable for patient outcomes over a long period of time. They won’t want to lose control of the patient. I first heard of this danger at a 2012 conference (described in the section titled “Low-hanging fruit signals a new path for cost savings”).

So the trade press routinely and ponderously reports that once again, years have gone by without much progress in data sharing. The US government recognizes that support for interoperability is unsatisfactory, and has recently changed the ONC certification program to focus on it.

Carla Kriwet, CEO of Connected Care and Health Informatics at Philips, was asked in her keynote Fireside Chat to rate the interoperability of health data on a scale from 0 to 10, and chose a measly 3. She declared that “we don’t believe in closed systems at all” and told me in an interview that Philips is committed to creating integrated solutions that work with any and all products. Although Philips devices are legendary in many domains, Kriwet wants customers to pay for outcomes, not devices.

For instance, Philips recently acquired the Wellcentive platform that allows better care in hospitals by adopting population health approaches that look at whole patient populations to find what works. The platform works with a wide range of input sources and is meant to understand patient populations, navigate care and activate patients. Philips also creates dashboards with output driven by artificial intelligence–the Philips IntelliVue Guardian solution with Early Warning Scoring (EWS)–that leverages predictive analytics to present critical information about patient deterioration to nurses and physicians. This lets them intervene quickly before an adverse event occurs, without the need for logging in repeatedly. (This is an example of another trend I cover in this article, the search for simpler interfaces.)

Kriwet also told me that Philips has incorporated the principles of agile programming throughout the company. Sprints of a few weeks develop their products, and “the boundary comes down” between R&D and the sales team.

I also met with Jon Michaeli, EVP of Strategic Partnerships with Medisafe, a company that I covered two years ago. Medisafe is one of a slew of companies that encourage medication adherence. Always intensely based on taking in data and engaging patients in a personalized way, Medisafe has upped the sophistication of their solution, partly by integrating with other technologies. One recent example is its Safety Net, provided by artificial intelligence platform Neura. For instance, if you normally cart your cell phone around with you, but it’s lying quiet from 10:00 PM until 6:00 AM, Safety Net may determine your reason for missing your bedtime dose at 11:00 PM was that you had already fallen asleep. If Safety Net sees recurring patterns of behavior, it will adjust reminder time automatically.

Medisafe also gives users the option of recording the medication adherence through sensors rather than responding to reminders. They can communicate over Bluetooth to a pill bottle cap (“iCap”) that replaces the standard medicine cap and lets the service know when you have opened the bottle. The iCap fits the vast majority of medicine bottles dispensed by U.S. pharmacies and costs only $20 ($40 for a pack of 2), so you can buy several and use them for as long as you’re taking your medicine.

On another level, Mivatek provides some of the low-level scaffolding to connected health by furnishing data from devices to systems developed by the company’s clients. Suppose, for instance, that a company is developing a system that responds to patients who fall. Mivatek can help them take input from a button on the patient’s phone, from a camera, from a fall detector, or anything else to which Mivatek can connect. The user can add a device to his system simply by taking a picture of the bar code with his phone.

Jorge Perdomo, Senior Vice President Corporate Strategy & Development at Mivatek, told me that these devices work with virtually all of the available protocols on the market that have been developed to promote interoperability. In supporting WiFi, Mivatek loads an agent into its system to provide an additional level of security. This prevents device hacking and creates an easy-to-install experience with no setup requirements.

Blockchains
Most famous as a key technological innovation supporting BitCoin, blockchains have a broad application as data stores that record transactions securely. They can be used in health care for granting permissions to data and other contractual matters. The enticement offered by this technology is that no central institution controls or stores the blockchain. One can distribute the responsibility for storage and avoid ceding control to one institution.

Blockchains do, however, suffer from inherent scaling problems by design: they grow linearly as people add transactions, the additions must be done synchronously, and the whole chain must be stored in its entirety. But for a limited set of participants and relatively rate updates (for instance, recording just the granting of permissions to data and not each chunk of data exchanged), the technology holds great promise.

Although I see a limited role for blockchains, the conference gave considerable bandwidth to the concept. In a keynote that was devoted to blockchains, Dr. Samir Damani described how one of his companies, MintHealth, planned to use them to give individuals control over health data that is currently held by clinicians or researchers–and withheld from the individuals themselves.

I have previously covered the importance patient health records, and the open source project spotlighted by that article, HIE of One, now intends to use blockchain in a manner similar to MintHealth. In both projects, the patient owns his own data. MintHealth adds the innovation of offering rewards for patients who share their data with researchers, all delivered through the blockchain. The reward system is quite intriguing, because it would create for the first time a real market for highly valuable patient data, and thus lead to more research use along with fair compensation for the patients. MintHealth’s reward system also fits the connected health vision of promoting healthy behavior on a daily basis, to reduce chronic illness and health care costs.

Conclusion
Although progress toward connected health comes in fits and starts, the Connected Health Conference is still a bright spot in health care each year. For the first time this year, Partners’ Center for Connected Health partnered with another organization, the Personal Connected Health Alliance, and the combination seems to be a positive one. Certain changes were noticeable: for instance, all the breakout sessions were panels, and the keynotes were punctuated by annoying ads. An interesting focus this year was wellness in aging, the topic of the final panel. One surprising difference was the absence of the patient advocates from the Society for Participatory Medicine whom I’m used to meeting each year at this conference, perhaps because they held their own conference the day before.

The Center for Connected Health’s Joseph Kvedar still ran the program team, and the themes were familiar from previous years. This conference has become my touchstone for understanding health IT, and it will continue to be the place to go to track the progress of health care reform from a technological standpoint.

Measuring the Vital Signs of Health Care Progress at the Connected Health Conference (Part 2 of 3)

Posted on November 15, 2017 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 segment of this article introduced the themes of the Connected Health Conference and talked about the importance of validating what new technologies do using trials or studies like traditional medical advances. This segment continues my investigation into another major theme in health care: advanced interfaces.

Speaker from Validic at Connected Health Conference

Speaker from Validic at Connected Health Conference

Advanced interfaces
The compulsory picture of health care we’re accustomed to seeing, whenever we view hospital propaganda or marketing from health care companies, shows a patient in an awkward gown seated on an uncomfortable examination table. A doctor faces him or her full on–not a computer screen in site–exuding concern, wisdom, friendliness, and professionalism.

More and more, however, health sites are replacing this canonical photograph with one of a mobile phone screen speckled with indicators of our vital signs or thumbnail shot of our caregivers. The promise being conveyed is no longer care from a trusted clinician in the office, but instant access to all our information through a medium familiar to almost everyone everywhere–the personal mobile device.

But even touchscreen access to the world of the cloud is beginning to seem fusty. Typing in everything you eat with your thumbs, or even answering daily surveys about your mental state, gets old fast. As Dr. Yechiel Engelhard of TEVA said in his keynote, patients don’t want to put a lot of time into managing their illnesses, nor do doctors want to change their workflows. So I’m fascinated with connected health solutions that take the friction out of data collection and transmission.

One clear trend is the move to voice–or rather, I should say back to voice, because it is the original form of human communication for precise data. The popularity of Amazon Echo, along with Siri and similar interfaces, shows that this technology will hit a fever pitch soon. One research firm found that voice-triggered devices more than doubled in popularity between 2015 and 2016, and that more than half of Americans would like such a device in the home.

I recently covered a health care challenge using Amazon Alexa that demonstrates how the technology can power connected health solutions. Most of the finalists in the challenge were doing the things that the Connected Health Conference talks about incessantly: easy and frequent interactions with patients, analytics to uncover health problems, integration with health care providers, personalization, and so on.

Orbita is another company capitalizing on voice interfaces to deliver a range of connected health solutions, from simple medication reminders to complete care management applications for diabetes. I talked to CEO Bill Rogers, who explained that they provide a platform for integrating with AI engines provided by other services to carry out communication with individuals through whatever technology they have available. Thus, Orbita can talk through Echo, send SMS messages, interact with a fitness device or smart scale, or even deliver a reminder over a plain telephone interface.

One client of Orbita uses it platform to run a voice bot that talks to patients during their discharge process. The bot provides post-discharge care instructions and answers patients’ questions about things like pain management and surgery wound care. The results show that patients are more willing to ask questions of the bot than of a discharge nurse, perhaps because they’re not afraid of wasting someone’s time. Rogers also said services are improving their affective interfaces, which respond to the emotional tone of the patient.

Another trick to avoid complex interfaces is to gather as much data as possible from the patient’s behavior (with her consent, of course) to eliminate totally the need for her to manually enter data, or even press a button. Devices are getting closer to this kind of context-awareness. Following are some of the advances I enjoyed seeing at the Connected Health Conference.

  • PulseOn puts more health data collection into a wrist device than I’ve ever seen. Among the usual applications to fitness, they claim to detect atrial fibrillation and sleep apnea by shining a light on the user’s skin and measuring changes in reflections caused by variations in blood flow.
  • A finger-sized device called Gocap, from Common Sensing, measures insulin use and reports it over wireless connections to clinical care-takers. The device is placed over the needle end of an insulin pen, determines how much was injected by measuring the amount of fluid dispensed after a dose, and transmits care activity to clinicians through a companion app on the user’s smartphone. Thus, without having to enter any information by hand, people with diabetes can keep the clinicians up to date on their treatment.
  • One of the cleverest devices I saw was a comprehensive examination tool from Tyto Care. A small kit can carry the elements of a home health care exam, all focused on a cute little sphere that fits easily in the palm. Jeff Cutler, Chief Revenue Officer, showed me a simple check on the heart, ear, and throat that anyone can perform. You can do it with a doctor on the other end of a video connection, or save the data and send it to a doctor for later evaluation.

    Tyto Care has a home version that is currently being used and distributed by partners such as Heath Systems, providers, payers and employers, but will ultimately be available for sale to consumers for $299. They also offer a professional and remote clinic version that’s tailor-made for a school or assisted living facility.

A new Digital Therapeutics Alliance was announced just before the conference, hoping to promote more effective medical devices and allow solutions to scale up through such things as improving standards and regulations. Among other things, the alliance will encourage clinical trials, which I have already highlighted as critical.

Big advances were also announced by Validic, which I covered last year. Formerly a connectivity solution that unraveled the varying quasi-standard or non-standard protocols of different devices in order to take their data into electronic health records, Validic has created a new streaming API that allows much faster data transfers, at a much higher volume. On top of this platform they have built a notification service called Inform, which takes them from a networking solution to a part of the clinicians’ workflow.

Considerable new infrastructure is required to provide such services. For instance, like many medication adherence services, Validic can recognize when time has gone by without a patient reporting that’s he’s taken his pill. This level of monitoring requires storing large amounts of longitudinal data–and in fact, Validic is storing all transactions carried out over its platform. The value of such a large data set for discovering future health care solutions through analytics can make data scientists salivate.

The next segment of this article wraps up coverage of the conference with two more themes.

Measuring the Vital Signs of Health Care Progress at the Connected Health Conference (Part 1 of 3)

Posted on November 13, 2017 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.

Attendees at each Connected Health Conference know by now the architecture of health reform promoted there. The term “connected health” has been associated with a sophisticated amalgam of detailed wellness plans, modern sensors, continuous data collection in the field, patient control over data, frequent alerts and reminders, and analytics to create a learning health care system. The mix remains the same each year, so I go each time to seek out progress toward the collective goal. This year, I’ve been researching what’s happening in these areas:

  • Validation through clinical trials
  • Advanced interfaces to make user interaction easier
  • Improved data sharing (interoperability)
  • Blockchains

Panel at Connected Health Conference

Panel at Connected Health Conference

There were a few other trends of interest, which I’ll mention briefly here. Virtual reality (VR) and augmented reality (AR) turned up at some exhibitor booths and were the topic of a panel. Some of these technologies run on generic digital devices–such as the obsession-inducing Pokémon GO game–while others require special goggles such as the Oculus Rift (the first VR technology to show a promise for widespread adoption, and now acquired by Facebook) or Microsoft’s HoloLens. VR shuts out the user’s surroundings and presents her with a 360-degree fantasy world, whereas AR imposes information or images on the surroundings. Both VR and AR are useful for teaching, such as showing an organ in 3D organ in front of a medical student on a HoloLens, and rotating it or splitting it apart to show details.

I haven’t yet mentioned the popular buzzword “telehealth,” because it’s subsumed under the larger goal of connected health. I do use the term “artificial intelligence,” certainly a phrase that has gotten thrown around too much, and whose meaning is subject of much dissension. Everybody wants to claim the use of artificial intelligence, just as a few years ago everybody talked about “the cloud.” At the conference, a panel of three experts took up the topic and gave three different definitions of the term. Rather than try to identify the exact algorithms used by each product in this article and parse out whether they constitute “real” artificial intelligence, I go ahead and use the term as my interviewees use it.

Exhibition hall at Connected Health Conference

Exhibition hall at Connected Health Conference

Let’s look now at my main research topics.

Validation through clinical trials
Health apps and consumer devices can be marketed like vitamin pills, on vague impressions that they’re virtuous and that doing something is better than doing nothing. But if you want to hook into the movement for wellness–connected health–you need to prove your value to the whole ecosystem of clinicians and caretakers. The consumer market just doesn’t work for serious health care solutions. Expecting an individual to pay for a service or product would limit you to those who can afford it out-of-pocket, and who are concerned enough about wellness to drag out their wallets.

So a successful business model involves broaching the gates of Mordor and persuading insurers or clinicians to recommend your solution. And these institutions won’t budge until you have trials or studies showing that you actually make a difference–and that you won’t hurt anybody.

A few savvy app and device developers build in such studies early in their existence. For instance, last year I covered a typical connected health solution called Twine Health, detailing their successful diabetes and hypertension trials. Twine Health combines the key elements that one finds all over the Connected Health Conference: a care plan, patient tracking, data analysis, and regular check-ins. Their business model is to work with employer-owned health plans, and to expand to clinicians as they gradually migrate to fee-for-value reimbursement.

I sense that awareness is growing among app and device developers that the way to open doors in health care is to test their solutions rigorously and objectively. But I haven’t found many who do so yet.

In the next segment of this article continues my exploration of the key themes I identified at the start of this article.

IBM Watson Partners With FDA On Blockchain-Driven Health Sharing

Posted on January 16, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

IBM Watson Health has partnered with the FDA in an effort to create scalable exchange of health data using blockchain technology. The two will research the exchange of owner-mediated data from a variety of clinical data sources, including EMRs, clinical trial data and genomic health data. The researchers will also incorporate data from mobiles, wearables and the Internet of Things.

The initial project planned for IBM Watson and the FDA will focus on oncology-related data. This makes sense, given that cancer treatment involves complex communication between multispecialty care teams, transitions between treatment phases, and potentially, the need to access research and genomic data for personalized drug therapy. In other words, managing the communication of oncology data is a task fit for Watson’s big brain, which can read 200 million pages of text in 3 seconds.

Under the partnership, IBM and the FDA plan to explore how the blockchain framework can benefit public health by supporting information exchange use cases across varied data types, including both clinical trials and real-world data. They also plan to look at new ways to leverage the massive volumes of diverse data generated by biomedical and healthcare organizations. IBM and the FDA have signed a two-year agreement, but they expect to share initial findings this year.

The partnership comes as IBM works to expand its commercial blockchain efforts, including initiatives not only in healthcare, but also in financial services, supply chains, IoT, risk management and digital rights management. Big Blue argues that blockchain networks will spur “dramatic change” for all of these industries, but clearly has a special interest in healthcare.  According to IBM, Watson Health’s technology can access the 80% of unstructured health data invisible to most systems, which is clearly a revolution in the making if the tech giant can follow through on its potential.

According to Scott Lundstrom, group vice president and general manager of IDC Government and Health Insights, blockchain may solve some of the healthcare industry’s biggest data management challenges, including a distributed, immutable patient record which can be secured and shared, s. In fact, this idea – building a distributed, blockchain-based EMR — seems to be gaining traction among most health IT thinkers.

As readers may know, I’m neither an engineer nor a software developer, so I’m not qualified to judge how mature blockchain technologies are today, but I have to say I’m a bit concerned about the rush to adopt it nonetheless.  Even companies with a lot at stake  — like this one, which sells a cloud platform backed by blockchain tech — suggest that the race to adopt it may be a bit premature.

I’ve been watching tech fashions come and go for 25 years, and they follow a predictable pattern. Or rather, they usually follow two paths. Go down one, and the players who are hot for a technology put so much time and money into it that they force-bake it into success. (Think, for example, the ERP revolution.) Go down the other road, however, and the new technology crumbles in a haze of bad results and lost investments. Let’s hope we go down the former, for everyone’s sake.

The “Disconnects” That Threaten The Connected World

Posted on January 11, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

I’m betting that most readers are intimately familiar with the connected health world. I’m also pretty confident that you’re pretty excited about its potential – after all, who wouldn’t be?  But from what I’ve seen, the health IT world has paid too little attention to problems that could arise in building out a connected health infrastructure. That’s what makes a recent blog post on connected health problems so interesting.

Phil Baumann, an RN and digital strategist at Telerx, writes that while the concept of connecting things is useful, there’s a virtually endless list of “disconnects” that could lead to problems with connected health. Some examples he cites include:

  • The disconnect between IoT hardware and software
  • The disconnect between IoT software and patches (which, he notes, might not even exist)
  • The disconnect between the Internet’s original purpose and the fast-evolving purposes created in the Connected World
  • The disconnects among communication protocols
  • The disconnect between influencers and reality (which he says is “painfully wide”)
  • The disconnects among IoT manufacturers
  • The disconnects among supply chains and vendors

According to Baumann, businesses that use IoT devices and other connected health technologies may be diving in too quickly, without taking enough time to consider the implications of their decisions. He writes:

Idea generation and deployment of IoT are tasks with enormous ethical, moral, economic, security, health and safety responsibilities. But without considering – deeply, diligently – the disconnects, then the Connected World will be nothing of the sort. It will be a nightmare without morning.

In his piece, Baumann stuck to general tech issues rather than pointing a finger at the healthcare industry specifically. But I’d argue that the points he makes are important for health IT leaders to consider.

For example, it’s interesting to think about vulnerable IoT devices posing a mission-critical security threat to healthcare organizations. To date, as Baumann rightly notes, manufacturers have often fallen way behind in issuing software updates and security patches, leaving patient data exposed. Various organizations – such as the FDA – are attempting to address medical device cybersecurity, but these issues won’t be addressed quickly.

Another item on his disconnect list – that connected health deployment goes far beyond the original design of the Internet – also strikes me as particularly worth taking to heart. While past networking innovations (say, Ethernet) have led to rapid change, the changes brought on by the IoT are sprawling and almost unmanageable under current conditions. We’re seeing chaotic rather than incremental or even disruptive change. And given that we’re dealing with patient lives, rather than, for example, sensors tracking packages, this is a potentially dangerous problem.

I’m not at all suggesting that healthcare leaders should pull the plug on connected health innovations. It seems clear that the benefits that derive from such approaches will outweigh the risks, especially over time. But it does seem like a good idea to stop and think about those risks more carefully.

FDA Weighs In On Medical Device Cybersecurity

Posted on January 5, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

In the past, medical devices lived in a separate world from standard health IT infrastructure, typically housed in a completely separate department. But today, of course, medical device management has become much more of an issue for health IT managers, given the extent to which such devices are being connected to the Internet and exposed to security breaches.

This has not been lost on the FDA, which has been looking at medical device security problems for a long time. And now – some would say “at long last” – the FDA has released final guidance on managing medical device cybersecurity. This follows the release of earlier final guidance on the subject released in October 2014.

While the FDA’s advice is aimed at device manufactures, rather than the health IT managers who read this blog, I think it’s good for HIT leaders to review. (After all, you still end up managing the end product!)

In the guidance, the FDA argues that the best way to bake cybersecurity protections into medical devices is for manufacturers to do so from the outset, through the entire product lifecycle:

Manufacturers should build in cybersecurity controls when they design and develop the device to assure proper device performance in the face of cyber threats, and then they should continuously monitor and address cybersecurity concerns once the device is on the market and being used by patients.

Specifically, the agency is recommending that manufacturers take the following steps:

  • Have a way to monitor and detect cybersecurity vulnerabilities in their devices
  • Know assess and detect the level of risk vulnerabilities pose to patient safety
  • Establish a process for working with cybersecurity researchers and other stakeholders to share information about possible vulnerabilities
  • Issue patches promptly, before they can be exploited

The FDA also deems it of “paramount” importance that manufacturers and stakeholders consider applying core NIST principles for improving critical infrastructure cybersecurity.

All of this sounds good. But considering the immensity of the medical device infrastructure – and the rate of its growth – don’t expect these guidelines to make much of an impact on the device cybersecurity problem.

After all, there are an estimated 10 million to 15 million medical devices in US hospitals today, according to health tech consultant Stephen Grimes, who spoke on biomedical device security at HIMSS ’16. Grimes, a past chair of the HIMSS Medical Device Security Task Force, notes that one 500-bed hospital could have 7,500 devices on board, most of which will be networked. And each networked monitor, infusion pump, ventilator, CT or MRI scanner could be vulnerable to attack.

Bottom line, we’re looking at some scary risks regardless of what manufacturers do next. After all, even if they do a much better job of securing their devices going forward, there’s a gigantic number of existing devices which can be hacked. And we haven’t even gotten into the vulnerabilities that can be exploited among home-based connected devices.

Don’t get me wrong, I’m glad to see the FDA stepping in here. But if you look at the big picture, it’s pretty clear that their guidance is clearly just a small step in a very long and complicated process.

The Required Shift in How Patients View Wearables

Posted on September 27, 2016 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

This post is sponsored by Samsung Business. All thoughts and opinions are my own.

We’ve all seen the explosive growth that’s occurred in the wearables market. The most extraordinary part of the wearables explosion is that the majority of wearables growth has been in the healthcare space. The problem we now see in healthcare is that most people don’t look at wearables as a disease management tool as much as they see them as lifestyle tools. This was described really well by Megan Williams on the Samsung Insights blog:

Perhaps the most challenging part of meeting that desire [Physician Access to Patients’ Lives and Health] is the fact that patients mostly view wearables as an aid in lifestyle improvement instead of disease management. The task of helping patients understand that wearables are about much more than weight loss will fall squarely on the shoulders of providers.

Patients have traditionally shown a preference for lifestyle apps including fitness, nutrition and heart rate aids, and have been much slower to adopt disease management tools, even as chronic disease remains a burden on healthcare as a whole. Encouraging the use of a broader range of wearables, digital tools and apps will be a challenge for any provider.

Changing habits and perceptions is always a challenge. However, it’s also a great opportunity.

No one would argue that today’s wearables are more than novelty items that may have some impact on your lifestyle (fitness, nutrition, etc). That’s largely because the initial wearables were designed around those retail areas of the market. It’s much easier to create a retail wearable device than to create a disease management focused healthcare device.

As the healthcare wearables market matures so will patients expectations around the benefits they can receive from those wearables. I think there are two main keys to development of wearables as true healthcare devices: Depth of Tracking and Connection to Providers.

Depth of Tracking
I’ve argued for a while now that all the various fitness trackers were not clinically relevant. I still believe that today, but I also believe that wearables like the various fitness trackers will start tracking us in ways that are clinically relevant. That just takes a lot longer to develop.

Whether it’s new trackers that screen for sleep apnea or ECGs that monitor our heart, we’re seeing more and more wearable devices monitoring data that’s more clinically relevant than the number of steps you’ve taken. This trend will continue. As wearables more deeply track various parts of the human body, the opportunities to understand your health and improve your health will follow along with it. This will provide doctors the impetus to request access to your wearable data.

The deep data these wearables will provide will challenge the tried and true beliefs healthcare holds so dearly today. That can be scary for some, but is also very exciting.

Connection to Providers
While wearables will provide the data, we’ll still want to consult a healthcare provider to understand the data and to create a plan of action based on that data. At least in the foreseeable future, our health will depend on collaboration with healthcare providers as opposed to a replacement of healthcare providers. This will be particularly true as the type of data our wearables collect gets more complicated. Understanding your step chart is quite different than understanding your ECG.

In order to facilitate this collaboration, our wearables will have to be connected to our care providers. Note that I said care providers and not doctors. In some cases it might be our doctor, but in other cases it could be a nurse, care manager, social worker, or some other care provider. I’m hopeful that we eventually reach the point of a true care team that collaborates on our health. That’s a far cry from where most of our healthcare is today, but that is the hope.

If we can solve these two wearable challenges: Deeper Data and Connected Providers, then we’ll be well on our way to changing how patients view wearables. This shift won’t happen over night, but I believe it will happen a lot quicker than most people imagine.

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