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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.

They Do Listen: Stage 2 Proposal Includes Some Changes to Stage 1 – Meaningful Use Monday

Posted on April 9, 2012 I Written By

Lynn Scheps is Vice President, Government Affairs at EHR vendor SRSsoft. In this role, Lynn has been a Voice of Physicians and SRSsoft users in Washington during the formulation of the meaningful use criteria. Lynn is currently working to assist SRSsoft users interested in showing meaningful use and receiving the EHR incentive money.

Lynn Scheps is Vice President, Government Affairs at EHR vendor SRSsoft. In this role, Lynn has been a Voice of Physicians and SRSsoft users in Washington during the formulation of the meaningful use criteria. Lynn is currently working to assist SRSsoft users interested in showing meaningful use and receiving the EHR incentive money. Check out Lynn’s previous Meaningful Use Monday posts.

Included in the Proposed Rule for Meaningful Use Stage 2 are several modifications to the requirements for Meaningful Use Stage 1—likely in response to a barrage of comments from providers. 

The MU Stage 1 measure requiring a test of the ability to exchange clinical data would be removed effective 2013. Apparently, the concept of a test created a great deal of confusion. This change, however, should not be interpreted as reduced interest in interoperability. In fact, Stage 2 is all about the sharing of data. The measure would be replaced in Stage 2 by numerous other measures that require the sharing of clinical information—both between providers and with patients. 

The “all 3 vital signs dilemma”, (described in a previous Meaningful Use Monday post), would be resolved by a change to the vital signs measure. Separating height and weight from blood pressure, the revised measure would allow a provider to meet the threshold for recording height and weight, while claiming an exclusion for blood pressure, (or vice-versa). This is good news for specialists like orthopaedists who may routinely document height and weight but who rarely document blood pressure unless it is relevant to a specific patient’s problem. This change would be available as an option in 2013, and formalized in 2014. (The vital signs measure would also increase the minimum age requiring blood pressure documentation from 2-year olds to 3-year olds.) 

Many providers reported a problem in meeting the CPOE measure because of the way the calculation was defined—particularly those providers whose treatment does not frequently include prescribing medication. Now, providers would be able to define the denominator as the number of medications ordered, rather than the “number of unique patients with at least one medication in the patient’s medication list”, (since that list often includes medications downloaded from Surescripts and prescribed by other providers.) There is already a CMS FAQ (#10369) that allows providers to use this alternate definition even in 2012.

The government is listening, so make your voice heard. Use your experience in Meaningful Use Stage 1 to influence Meaningful Use Stage 2. Submit your comments on the Proposed Rule for Stage 2.

Real Participation in RHIO and HIE

Posted on November 28, 2009 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.

Everyone seems to love talking about RHIO, HIE and all of the other various initiatives happening around sharing patient health information amongst doctors. This weekend, I want to open it up to you the readers to get an idea of what type of participation you’ve had in an RHIO, HIE or other clinical data exchange.

Are you participating in one now? Do you like it? Do you hate it? In fact, what do you like and what do you hate? Do you use an EMR to interface with the exchange? What’s the interface like? How much work is it to manage the interface?

I’d also be interested in hearing about people who are working through the process now. Where are you at in the process? What’s holding you up from making this happen?

Let’s help educate each other on what’s happening with something that I think we can all universally agree is important and INCREDIBLY challenging.