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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.

Latest Apple Watch to Cure Heart Disease (Yes, That’s the Sarcasm Font)

Posted on September 13, 2018 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.

By this point, I think that most people have seen the big announcement coming out of the Apple event that the Apple Watch 4 now has ECG and other heart monitoring capabilities built in. The watch will notify you if your heart rate is too low and instances of atrial fibrillation that it detects. Plus, all of this is done as an FDA cleared device (some are reporting that Apple got their FDA clearance in 30 days which is crazy fast for a medical device).

The response to this announcement has been quite interesting. Most aren’t surprised that Apple has been moving more and more into healthcare. Plus, there have been a lot of reports that have mistakenly called this the first consumer ECG which it’s not. AliveCor deserves that credit and I recently wrote about another consumer ECG which is just one of many that are coming. However, many are suggesting that the Apple Watch will be the first time that many younger, healthier people will be regularly using an ECG like this. That’s an interesting idea.

As you might have assumed by the title of this post, I think the Apple Watch announcement isn’t much ado about nothing, but it’s also not the announcement of “sliced bread” being invented either. Let’s dive into what this announcement really means for healthcare.

As I mentioned when I wrote about the other consumer ECG, there’s currently somewhat limited value in what can be done with a single lead ECG. So, it’s important to keep this Apple Watch announcement in the right perspective even though I’m sure most consumers won’t understand these details. One person even commented on how Apple created messaging that calls it an “intelligent health guardian” to confuse people while still avoiding liability:

Perception sells and Apple is as good at creating perception as anyone. Will many more people buy an Apple Watch if they perceive it as something that will help them monitor their health better? Definitely. However, there are some other consequences that many doctors are warning about when it comes to this type of tracking hitting the masses.

First up is Dr. Nick van Terheyden who provides a comparative example of why all this “testing” could lead to a lot of incidentloma’s (Nice word I assume he made up to describe false positives in health tests):

A nephrologist at Cricket Health, Carmen A. Peralta, chimed in with this perspective:

The problem with these devices is that it’s not in Apple’s best interest to truly educate a patient on what the device can and can’t do. If a single lead ECG like this was a reliable arbitrator of when to go to the ED or when to not go, then it would be extremely valuable. However, many doctors I’ve talked to are suggesting that a single lead ECG isn’t sufficient for this type of information. So, a false negative or a false positive from the Apple Watch can provide incorrect reassurance or unfortunate anxiety that is dangerous. Who’s going to communicate this information to the unsuspecting Apple Watch buyer? My guess is relatively no one.

Another doctor made this ironic observation when it comes to the false positives the Apple Watch will produce:

You can just imagine the Apple Watch template in an EHR system. I wonder if it will include an Apple Watch education sheet. Maybe the EHR could send that education sheet to their watch instead of the portal. Wishful thinking…I know.

Another doctor made this poignant observation about the announcement:

We could go on for a while about prevention versus diagnosis. However, I don’t think it’s really an either or proposition. Prevention is great, but detection and diagnosis are as well since we can’t prevent everything.

This MD/PhD student summed up where we’re at with these consumer health devices really well:

I agree completely. The Apple Watch is directionally good, but still far away from really making a significant impact on health and/or our healthcare sysetm.

Being Honest About Your Reasons For Cybersecurity Decisions

Posted on August 16, 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.

This week, a team of McAfee researchers released a paper outlining a terrifying exploit. The paper describes, in great technical detail, how a malicious attacker could flip a cardiac rhythm display from 80 beats per minute to zero within less than five seconds.

This might not lead to severe harm or death, but it’s possible that other very negative outcomes could occur, notes Shaun Nordeck, MD, who’s quoted in the report. “Fictitious cardiac rhythms, even intermittent, could lead to extended hospitalization, additional testing, and side effects from medications prescribed to control heart rhythm and/or prevent clots,” he notes.

The paper does point out that if the bedside monitor is working normally, nurses have access to other accurate data, which could diminish the impact of such disruptions to some extent. However, the potential for adverse events is clearly higher than normal if someone scrambles a patient’s vitals.

Unfortunately, this is far from the only attack which wasn’t possible before connected devices became the norm. At various points, we’ve seen that pacemakers, insulin pumps and even MRIs can be hacked externally, particularly if their operating systems aren’t patched as required or haven’t put even basic security protections in place. (Think using “password” as a password.)

But while these vulnerabilities are largely known at this point, some healthcare organizations haven’t begun to tackle them. Solving these problems takes work, and costs money, The best-intentioned CIO might not get the budget to fix these problems if their CEO doesn’t see them as urgent.

Or let’s say the budget is available to begin the counterattack. Even if everyone agrees to tackle connected device vulnerabilities, where do we begin the counterattack? Which of these new connected health vulnerabilities are the most critical?  On the one hand, hacking individual pacemakers doesn’t seem profitable enough to attract many cybercriminals. On the other, if I were a crook I might see the threat of meddling with a hospitals’ worth of patient monitors to be a great source of ransom money.

And this brings us to some tough ethical questions. Should we evaluate these threats by how many patients would be affected, or how many of the sickest patients?  How do we calculate the clinical impact of vital signs hacking vs. generating inaccurate MRI results? To what extent should the administrative impact of these attacks be a factor in deciding how to defeat these challenges, if at all?

I know you’re going to tell me that this isn’t an all or nothing proposition, and that to some extent standard network intrusion detection techniques and tools will work. I’m not disputing this. However, I think we need to admit out loud that these kinds of attacks threaten individual lives in a way that traditional cyberattacks do not. For that reason, we need to get honest about who we need to protect — and why.

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.

Hopes for Big Impact from Validic: Making Use of Consumer Device Data

Posted on March 20, 2018 I Written By

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

Validic, a company that provides solutions in data connectivity to health care organizations, came to HIMMS this year with a new platform called Impact that takes a big step toward turning raw data into actionable alerts. I talked to Brian Carter, senior vice president of product at Validic, about the key contributions of Impact.

Routinely, I find companies that allow health-related monitoring in the home. Each one has a solution it’s marketing to doctors: a solution reminding patients to take their meds, monitoring vital signs for diabetes, monitoring vital signs for congestive heart failure, or something else fairly specific. These are usually integrated solutions that provide their own devices. The achievement of Validic, built through years of painstakingly learning the details of almost 400 different devices and how to extract their data, is to give the provider control over which device to use. Now a provider can contract with some application developer to create a monitoring solution for diabetes or whatever the provider is tracking, and then choose a device based on cost, quality, and suitability.

Validic’s Impact platform actually does many of the things that a third-party monitoring solution can do. But rather than trying to become a full solutions provider for such things as hospital readmissions, Validic augments existing care management systems by integrating its platform directly into the clinical workflow. With Impact, clinicians can draw conclusions directly from the data they collect to generate intelligent alerts.

For instance, a doctor can request that Impact sample data from a sensor at certain intervals and define a threshold (such as blood sugar levels) at which Impact contacts the doctor. Carter defines this service more as descriptive analytics than predictive analytics. However, Validic plans to increase the sophistication of its analysis to move more toward predictive analytics. Thus, they hope in the future not just to report when blood sugar hits a dangerous threshold, but to analyze a patient’s data over time and compare it to other patients to predict if and when his blood sugar will rise. They also hope to track the all too common tendency to abandon the use of consumer devices, and predict when a patient is likely to do so, allowing the doctor to intervene and offer encouragement to keep using the device.

Validic has evolved far beyond its original mission of connecting devices to health care providers and wellness organizations. This mission is still important, because device manufacturers are slow to adopt standards that would make such connections trivial to implement. Most devices still offer proprietary APIs, and even if they all settled on something such as FHIR, Carter says that the task of connecting each device would still require manual programming effort. “Instead of setting up connections to ten different devices, a hospital can connect to Validic once and get access to all ten.”

However, interconnection is slowly progressing, so Validic needs to move up the value chain. Furthermore, clinicians are slow to use the valuable information that devices in the home can offer, because they produce a flood of data that is hard to interpret. With Impact, they can derive some immediate benefit from device data, as the critical information is elevated above the noise while still being integrated into their health records. They can contract further with other application developers to run analytical services and integrate with their health records.

Nokia May Exit Digital Health Business

Posted on March 2, 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.

The digital health market has become phenomenally competitive over the last few years, with giants like Google and Apple duking it out with smaller, fast-moving startups over the choicest opportunities in the sector.

Even with a behemoth like Google, you expect to see some stumbles, and the Internet giant has taken a few. But seldom have we seen a billion-dollar company walk away from the digital health market, which arguably stands to grow far more. Still, according to a recent news report, that’s just what Nokia may be doing.

A story published in The Verge reports that the Finnish telecom giant has launched a strategic review of its health division. While Nokia apparently isn’t spilling the beans on its plans, the news site got a look at an internal company memo which suggests that its digital health business is indeed in trouble.

In the memo, The Verge says, Nokia chief strategy officer Kathrin Buvac wrote that “our digital health business has struggled to scale and meet its growth expectations… [And] currently, we don’t see a path for [the digital health business] to become a meaningful part of a company as large as Nokia.”

While it’s hard to tell much from a press release, it notes that Nokia’s digital health division makes and sells an ecosystem of hybrid smart watches, scales and digital health devices to consumers and enterprises. Its digital health history includes the acquisition of Withings, a French startup with a sexy line up of connected health-focused digital health devices.

This may be in part because it just hasn’t been aggressive enough or offered anything unique. In the wake of the Withings acquisition, Nokia doesn’t seem to have done much to build on Withings’ product line. Though much of the success in this market depends on execution, its current roster of products doesn’t sound like anything too exciting or differentiated.

It’s interesting to note that Buvac blames at least part of the failure of its digital health excursion on Nokia’s size. That doesn’t seem to be a problem for industry-leading companies like Apple, which seems to be carving out its digital health footprint one launch at a time and cultivating health leaders along the way. For example, Apple recently partnered with Stanford Medicine launch an app using its smartwatch to collect data on irregular heart rhythms. Arguably, this is the way to win markets and influence people — slow and steady.

In the end, though, Buvac is probably right about is digital health prospects. Nokia’s seeming failure may indeed be attributed to its sprawling portfolio, and probably an inflexible internal culture as well. The moral of the story may be that winning at the digital health game has far more to do with understanding the market than it does with having very deep pockets.

Key Articles in Health IT from 2017 (Part 2 of 2)

Posted on January 4, 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 set a general context for health IT in 2017 and started through the year with a review of interesting articles and studies. We’ll finish the review here.

A thoughtful article suggests a positive approach toward health care quality. The author stresses the value of organic change, although using data for accountability has value too.

An article extolling digital payments actually said more about the out-of-control complexity of the US reimbursement system. It may or not be coincidental that her article appeared one day after the CommonWell Health Alliance announced an API whose main purpose seems to be to facilitate payment and other data exchanges related to law and regulation.

A survey by KLAS asked health care providers what they want in connected apps. Most apps currently just display data from a health record.

A controlled study revived the concept of Health Information Exchanges as stand-alone institutions, examining the effects of emergency departments using one HIE in New York State.

In contrast to many leaders in the new Administration, Dr. Donald Rucker received positive comments upon acceding to the position of National Coordinator. More alarm was raised about the appointment of Scott Gottlieb as head of the FDA, but a later assessment gave him high marks for his first few months.

Before Dr. Gottlieb got there, the FDA was already loosening up. The 21st Century Cures Act instructed it to keep its hands off many health-related digital technologies. After kneecapping consumer access to genetic testing and then allowing it back into the ring in 2015, the FDA advanced consumer genetics another step this year with approval for 23andMe tests about risks for seven diseases. A close look at another DNA site’s privacy policy, meanwhile, warns that their use of data exploits loopholes in the laws and could end up hurting consumers. Another critique of the Genetic Information Nondiscrimination Act has been written by Dr. Deborah Peel of Patient Privacy Rights.

Little noticed was a bill authorizing the FDA to be more flexible in its regulation of digital apps. Shortly after, the FDA announced its principles for approving digital apps, stressing good software development practices over clinical trials.

No improvement has been seen in the regard clinicians have for electronic records. Subjective reports condemned the notorious number of clicks required. A study showed they spend as much time on computer work as they do seeing patients. Another study found the ratio to be even worse. Shoving the job onto scribes may introduce inaccuracies.

The time spent might actually pay off if the resulting data could generate new treatments, increase personalized care, and lower costs. But the analytics that are critical to these advances have stumbled in health care institutions, in large part because of the perennial barrier of interoperability. But analytics are showing scattered successes, being used to:

Deloitte published a guide to implementing health care analytics. And finally, a clarion signal that analytics in health care has arrived: WIRED covers it.

A government cybersecurity report warns that health technology will likely soon contribute to the stream of breaches in health care.

Dr. Joseph Kvedar identified fruitful areas for applying digital technology to clinical research.

The Government Accountability Office, terror of many US bureaucracies, cam out with a report criticizing the sloppiness of quality measures at the VA.

A report by leaders of the SMART platform listed barriers to interoperability and the use of analytics to change health care.

To improve the lower outcomes seen by marginalized communities, the NIH is recruiting people from those populations to trust the government with their health data. A policy analyst calls on digital health companies to diversify their staff as well. Google’s parent company, Alphabet, is also getting into the act.

Specific technologies

Digital apps are part of most modern health efforts, of course. A few articles focused on the apps themselves. One study found that digital apps can improve depression. Another found that an app can improve ADHD.

Lots of intriguing devices are being developed:

Remote monitoring and telehealth have also been in the news.

Natural language processing and voice interfaces are becoming a critical part of spreading health care:

Facial recognition is another potentially useful technology. It can replace passwords or devices to enable quick access to medical records.

Virtual reality and augmented reality seem to have some limited applications to health care. They are useful foremost in education, but also for pain management, physical therapy, and relaxation.

A number of articles hold out the tantalizing promise that interoperability headaches can be cured through blockchain, the newest hot application of cryptography. But one analysis warned that blockchain will be difficult and expensive to adopt.

3D printing can be used to produce models for training purposes as well as surgical tools and implants customized to the patient.

A number of other interesting companies in digital health can be found in a Fortune article.

We’ll end the year with a news item similar to one that began the article: serious good news about the ability of Accountable Care Organizations (ACOs) to save money. I would also like to mention three major articles of my own:

I hope this review of the year’s articles and studies in health IT has helped you recall key advances or challenges, and perhaps flagged some valuable topics for you to follow. 2018 will continue to be a year of adjustment to new reimbursement realities touched off by the tax bill, so health IT may once again languish somewhat.

Key Articles in Health IT from 2017 (Part 1 of 2)

Posted on January 2, 2018 I Written By

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

This article provides a retrospective of 2017 in Health It–but a retrospective from an unusual perspective. I will highlight interesting articles I’ve read from the year as pointers to trends we should follow up on in the upcoming years.

Indubitably, 2017 is a unique year due to political events that threw the field of health care into wild uncertainty and speculation, exemplified most recently by the attempts to censor the use of precise and accurate language at the Centers for Disease Control (an act of political interference that could not be disguised even by those who tried to explain it away). Threats to replace the Affordable Care Act (another banned phrase) drove many institutions, which had formerly focused on improving communications or implementing risk sharing health care costs, to fall back into a lower level of Maslow’s hierarchy of needs, obsessing over whether insurance payments would cease and patients would stop coming. News about health IT was also drowned out by more general health topics such as drug pricing, the opiate crisis, and revenue pressures that close hospitals.

Key issues

But let’s start our retrospective on an upbeat note. A brief study summary from January 4 reported lower costs for some surgeries when hospitals participated in a modest bundled payment program sponsored by CMS. This suggests that fee-for-value could be required more widely by payers, even in the absence of sophisticated analytics and care coordination. Because only a small percentage of clinicians choose bold risk-sharing reimbursement models, this news is important.

Next, a note on security. Maybe we should reprioritize clinicians’ defenses against the electronic record breaches we’ve been hearing so much about. An analysis found that the most common reason for an unauthorized release of data was an attack by an insiders (43 percent). This contrasts with 26.8 percent from outside intruders. (The article doesn’t say how many records were compromised by each breach, though–if they had, the importance of outside intruders might have skyrocketed.) In any case, watch your audit logs and don’t trust your employees.

In a bracing and rare moment of candor, President Obama and Vice President Biden (remember them?) sharply criticized current EHRs for lack of interoperability. Other articles during the year showed that the political leaders were on target, as interoperability–an odd health care term for what other industries call “data exchange”–continues to be just as elusive as ever. Only 30% of hospitals were able to exchange data (although the situation has probably improved since the 2015 data used in the study). Advances in interoperability were called “theoretical” and the problem was placed into larger issues of poor communication. The Harvard Business Review weighed in too, chiding doctors for spending so much money on systems that don’t communicate.

The controversy sharpened as fraud charges were brought against a major EHR vendor for gaming the certification for Meaningful Use. A couple months later, strangely, the ONC weakened its certification process and announced it would rely more on the vendors to police themselves.

A long article provided some historical background on the reasons for incompatibility among EHRS.

Patients, as always, are left out of the loop: an ONC report finds improvements but many remaining barriers to attempts by patients to obtain the medical records that are theirs by law. And should the manufacturers of medical devices share the data they collect with patients? One would think it an elementary right of patients, but guidance released this year by the FDA was remarkably timid, pointing out the benefits of sharing but leaving it as merely a recommendation and offering big loopholes.

The continued failure to exchange data–which frustrates all attempts to improve treatments and cut costs–has led to the question: do EHR vendors and clinicians deliberately introduce technical measures for “information blocking”? Many leading health IT experts say no. But a study found that explicit information blocking measures are real.

Failures in interoperability and patient engagement were cited in another paper.

And we can’t leave interoperability without acknowledging the hope provided by FHIR. A paper on the use of FHIR with the older Direct-based interoperability protocols was released.

We’ll make our way through the rest of year and look at some specific technologies in the next part of the article.

Scanadu to Shut Down Scout Medical Device Per FDA Regulation

Posted on December 14, 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.

The famous Qualcomm Tricorder prize winner and IndieGogo crowdfunding success, Scanadu, has just hit some major bumps in the road. In fact, you might say they lost their engine completely. After winning the X Prize foundation’s tricorder competition, they went on to raise more than $1.6 million on IndieGogo from 8509 backers.

After shipping the product, Techcrunch just broke the news that Scanadu was now planning to disable the Scout’s functionality. Yes, that’s right. People paid $149-269 for the Scanadu Scout and now Scanadu is going to brick all of the devices. Here’s their official comment to Techcrunch:

“From the beginning of the campaign, this was an investigational device that was part of a study which has now reached its endpoint with data collection for the study ending in November 2016. FDA regulations require that all investigational studies be brought to closure and their respective devices be deactivated. As a result, we will deactivate the Scanadu Scout® devices by May 15, 2017.

Interestingly, the Scanadu website, Twitter, Facebook, etc are all quiet. In fact, most of them have been quiet since April. What hasn’t been quiet is customers anger towards Scanadu. That’s true on social media, but also in the IndieGogo comment section where Scanadu had raised $1.6 million.

You can imagine people’s anger. Their expensive device will now be useless. As one commenter pointed out, someone bought 100 of them. That person will now essentially have 100 expensive bricks. In the comments, people are calling for a class action lawsuit, refunds from IndieGogo and outrage at the company doing this to them. The most salient point is that it’s hard to imagine anyone ever buying a product from Scanadu again after something like this occurs. One commenter suggested the following:

The consent doc also says: “If you have any questions about your rights, call the Scripps Office for the Protection of Research Subjects at (858) 652-5500. ” [Note: Scripps is performing the study based on the Scanadu data.]

Some people in the comments are even commenting that there’s no such FDA regulation. I’m not an expert on FDA regulation, but my gut tells me there’s more to this story than we know today. I could easily see how there could be an FDA regulation that required a company to shut down devices that made claims they couldn’t achieve and therefore put people’s health in danger. I’m not sure if this is what’s happening with Scanadu, but when there’s smoke there’s usually fire.

I think we all loved the romanticized idea of a medical tricorder. Haven’t we all wanted one since we first saw it portrayed on Star Trek? Scanadu was trying to make it a reality, but it seems their efforts have fallen flat. This is a good warning to everyone else out there. FDA compliance is no joke. Even winning an X Prize, a successful crowd funding campaign, and raising $35 million in funding doesn’t guarantee success.

Innovation in healthcare is hard!