More on Health Apps: Opportunities, Risks and the Implications for Population Health Management

It's called "mHealth" but others may call it "health apps." The FDA calls it a target rich regulatory opportunity. Others may call it hype.

The Disease Management Care Blog calls it inevitable.

Writing in JAMA, Drs. Steinhubl, Muse and Topol of Scripps agree and say that the future is bright for mHealth. Its adoption is being driven by the threefold convergence of:

1) the search for solutions that address otherwise unaffordable levels of healthcare spending,

2) the availability of broadband wireless connectivity, and

3) consumer demand for individualized care.

The DMCB suspects any one of the DMCB's 5000 regular readers could have written this article. Like Steinhubl et al, they already know that patients want self-diagnosis and condition monitoring. Health consumers want greater efficiencies and enhanced patient-physician collaboration.

Even tech-skeptics have to admit that it's possible that mHealth could lead to a utilization trifecta of fewer office visits, avoided emergency room visits and decreased hospitalizations. Imagine the handheld that can accurately catalog signs and symptoms that help the user discern between a simple self-limited cold vs. a more serious case of pneumonia, or benign skipped heart beats vs. a more worrisome arrythmia.

Handheld apps for chronic conditions are more available than realized. They are on the cusp of going mainstream with assisting hypertensives, diabetics and asthmatics monitor and act on their blood pressure, insulin dosing and inhalants.

If they work right, providers could review summary data and offer guidance via emails and texts in lieu of adding a patient on to the schedule at 5 PM. If done right, the background algorithms could liberate physicians to pay greater attention to the important stuff that requires their complex cognitive or procedural skills.

The authors point out that that doesn't mean it's going to be easy. Medicine is complex and getting paid for it is more so. There's also worry - warranted or not - about the decline of face-to-face doctor-patient relationship. mHealth can lead to overwhelming data gluts characterized by a lot of numbers with little actionable insight. Finally, there's the danger that an app can offer ineffective, inaccurate or dangerous guidance that leads to patient harm.

Bravo to the editors of JAMA for recognizing the importance of the topic and committing precious space to this manuscript.

That being said, however, this article fails to give a full accounting of all the opportunities as well as risks for "mHealth."

First off, as this Kaiser Health News article demonstrates, there are two additional opportunity dimensions that draw on the population health management business model:

1) Apps are not just for diagnosis and monitoring, but also for wellness, and

2) They're being principally sponsored by commercial health insurers who not only readily embrace innovation, but probably consider apps a "sticky" way to maintain customer loyalty. That is doubly true for engaged enrollees who ultimately represent a better insurance risk.  In fact, the DMCB suspects that value proposition is so compelling that insurers are willing to use apps as a "loss leader."

Oh, and while mHealth can be built, it's far more likely it's being bought. As in population health management vendors.

Risks?  You bet.....

1) The fit of mHealth with the electronic health record (EHR) remains an open question.  The DMCB is no coding geek, but it's safe to say that it's not automatic that two independently contrived technologies can automatically "speak" to each other or that the data from an app can by downloaded, summarized and coherently presented to a user at the point of care.

2)  As noted in this article on telemonitoring, it's also not necessarily true that mHealth can be equated with stand-alone technology. Depending on the condition and the need, mHealth will have to be often tethered to human support services.

3) As even casual observers are aware, allegations of "malpractice" are not unusual in health care.  Rather than comment on its friends who make a living off of contingency fees, the DMCB will only point out that mHealth may offer a target-rich rich environment for personal injury attorneys intent on using the legal theory of joint and several liability to maximum effect.  That threat may slow adoption of mHealth.

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Ten Things to Know About the mHealth App Ecosystem.

A mHealth app walled garden:
enter at your own risk?

If, like the Population Health Blog, you're interested in the hand-held mHealth app ecosystem, you may want to check out this just published JAMA review article "In Search of a Few Good Apps." 

Naturally, for time-pressed readers who'd rather not read it all, your PHB is happy to provide this ten point summary.

1) There are more than 40,000 of mHealth apps and the industry is still in its infancy.

2) Despite their faddish sexiness, there is very little hard evidence that many of the commercially available apps to lead to measurable improvements in clinical or economic outcomes. However, some of the underlying technology (such as pedometers) does provide a benefit.

3) The Food and Drug Administration (FDA) will assert its regulatory authority if the app "acts" like a "medical device" or as an accessory to a "medical device." Logging data, retrieving content or communicating won't be regulated, but medication dosing guides or the provision of diagnostic information will be.

4) 3) Little is known about the physician prescribing patterns for apps.  We also haven't figured out if or how a patient's access to an app should depend on a licensed professional's approval/prescription.

5) There is a possibility that many currently available apps are putting users' privacy at risk.

6) Little is known about apps' compatibility with electronic health records (EHRs).  This may be less of an "ecosystem" and more a bunch of isolated "walled gardens."

7) One vulnerability to any app's usefulness is data overload. Hundreds of food entries, for example, may do little to increase user insight about his or her diet.

8) Other than the FDA and its fussing over apps' medical "deviceness", there is no agency or entity that provides certification for apps. Consumers are on their own, based largely on on-line reviews and word of mouth.  One organization tried to do it and conspicuously failed.

9) The time is right to create "guidelines" for app developers, such as how to provide useful data summaries as well as visual displays, maximize patient safety, ensure information accuracy and protect consumer privacy.

10) The time is also right for funding agencies to support research on apps, especially for persons with chronic illness.

Naturally, the PHB offers commentary:

It remains to be seen if the FDA can keep up, especially with apps that are in the "grey zone" between offering advice/possibilities vs. diagnosis/treatment. That shortcoming is vulnerable to overlawyering and regulatory overreach. That means prolonged time to market, increased uncertainty, hampered innovation and the threat of retroactive and potentially capricious reviews.

As you are reading this, many apps are undoubtedly being developed by the population health service providers.  It may be time for entities like the Population Health Alliance or stakeholder organized medicine organizations to take the lead in establishing app benchmarks, best practices and guidelines.  If they don't lead on this, someone will do it to them. 

While vendors that offer apps along with their coaching may be inclined to regard them as proprietary and shield them from the scrutiny of peer review research, apps that are proven to improve outcomes will ultimately rise to the top.  It's not just the funding agencies but the companies that offer these apps that have a stake in "proving it," while also advancing medical knowledge for the betterment of all of us.

Finally, wouldn't it be neat if there was a generic mHealth app that could be used by medical homes to facilitate nurse-patient coaching, link the patient to the EHR and enhance communication with providers?  If there is one that the PHB isn't aware of, it wants to know about it.

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mHealth Apps to Monitor Recently Discharged Patients

After knee surgery: how do you
monitor this patient at home?

The "this paper" link in the original post directed readers to the wrong web site.  It's been corrected and the PHR apologizes for the error)

While the Population Health Blog is tantalized by the prospect of healthcare consumers using mHealth apps to lower costs, increase quality and improve care, it wanted to better understand their real-world value propositions. 

Are app-empowered patients less likely to use the emergency room?

Do they have a higher survival rate? 

Do they have higher levels of satisfaction?

In other words, where's the beef?

That's when this paper caught the PHB's search engine eye. It's a report on using an app to monitor post-operative patients at home.

This was a "feasibility study" involving a Canadian cohort of home-based post-operative patients who had gone through either reconstructive breast or knee (anterior cruciate repair) surgery. In order to qualify, patients had to be between age 18 years and 75 years, not using tobacco and able to speak English.  Once the app was activated, patient were asked about pain, their recovery and satisfaction (using a 1 to 4 scale).  They also used the app to take pictures of the surgical site. 

To maintain confidentiality, there were no patient identifiers linked to any images and a "locked down" subscriber identify module (SIM) was used. Data was encrypted on the server and the device.

Three surgeons participated and were responsible for reviewing their patients' data on a daily basis.  The app flagged any measure that was unexpectedly out of range for expedited review.

Instruction on use of the app took between 30 and 45 minutes. Patients were loaned a smartphone or a tablet, along with an instructional booklet.  At the end of the 30 day period, the smartphone or tablet had to be returned.

38 breast patients were approached at 33 agreed to participate.  40 orthopedic patients were approached and 32 agreed to participate.

Results?

The mean number of log-ins over the 30 days ranged from 19 to 24, with greater use in the first half of the month. Over 2000 photos were generated. Based on the pain and recovery scales, two early infections were identified and one was treated over the phone with antibiotics with subsequent improvement. On a 1 to 4 scale, the overall level of satisfaction was 2.7 to 3.9.

The PHB's take?

It would appear that the science on using apps to address specific outcomes in narrowly defined populations is still in its infancy.  While the Triple-Aim potential of mHealth is high, we're just beginning to understand how an app would work in the real world, say.... monitoring the outpatient status of recently discharged surgery patients.

That's why this particular study was interesting. It would appear handhelds or tablets can be used in the post-operative setting, that patient satisfaction is high and that, with symptom monitoring and imaging, an early wound infection can be identified and managed early.

Naturally, it'll take a study involving a control group to better understand the true value of an app like this.  Based on this feasibility study, the PHB is looking forward to reading about it in the not too distant future.

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Either You Give Your Patients a mHealth App, or They'll Get One Themselves

That's what the Population Health Blog learned after reading this research paper by Bauer and colleagues that recently appeared in the Journal of the America Board of Family Medicine.

It also confirmed that chronic care management apps are a business opportunity.

What was the research and what did it show?

All adult patients receiving care at six clinics in a northwest U.S. primary care network during a two week window of time (June 2015) were anonymously surveyed about their use of mHealth.

Depending on the clinic, 22% to 62% of the patients were insured by Medicaid.  More demographic info can be found here.

1363 surveys were distributed and 918 (67%) were completed. 

91% had a mobile phone and more than half (55%) owned a smart phone.

Among the smart phone owners, 70% had used "mHealth." 57% had downloaded at least one app. Of these, 69% used it less than 3 times a month, while 11% used it on a daily basis.

There was no association of mHealth participation with health literacy, chronic conditions or depression. Use was more prevalent among persons less than age 45.

One third used "general" health apps, while one quarter used fitness, diet or weight-loss apps. Only 3% used it for chronic disease management.

The authors asked respondents to use a 1-5 scale to rate the desirability of various app features. Appointment reminders came in first, followed by medication reminders and general health information.

10% learned about this from their physicians and only 31% "prioritized" their physician's involvement.

The PHB's summary:

Smart phone and app use may be more prevalent in the northwest, which may make the findings of this survey less generalizable to the rest of the United States.  With that caveat, approximately 40% of the patients sitting in the average primary care clinic waiting room are mHealth users and about 20% are using health apps. And what do patients most prize in their apps?  Reminders about appointments and medications.

What's more, most of this is occurring without the benefit of their providers' participation.

Last but not least, apps have not penetrated the chronic disease population.

The PHB's take?

1) If all those patients with smart phones are going to download apps, they might as well download ones that - at a minimum - are endorsed by their providers. Optimally, they should complement their providers' services.  Used right, they might be able meet their patient's desires for coordinated appointments and increased medication compliance. 

Providers and patients would benefit from better quality and lower costs.

2) And patients with chronic conditions have yet to discover apps.  That may be a function of age, but it may also be a function of the conspicuous silence of their providers as well as the failure of the currently available apps to meet their potential customers' desires. 

That spells opportunity.  Recall the adage of the two shoe salespersons who were sent to Africa.  The more pessimistic of the two found that none of the natives were using shoes and decided to return home.  The optimist likewise found that no one was using shoes, but he called back to the home office and asked for help.

The market for chronic care apps needs help.

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Could mHealth Apps Be a Reprise of the EHR? The Need for Clinician Input

While the Population Health Blog continues to delight in the emerging science of "mHealth" as a newly minted start-up Chief Medical Officer, it ran across this interesting article on risk and patient safety.

Authors Thomas Lewis and Jeremy Wyatt worry that "apps" can lead to patient harm. 

They posit that the likelihood of harm is mainly a function of 1) the nature of the mistake itself (miscalculating a body mass index is far less problematic than miscalculating a drug dose) and 2) its severity (overdosing on a cupcake versus a narcotic).  When you include other "inherent and external variables," including the display, the user interface, network issues, information storage, informational complexity and the number of patients using it, the risks can grow from a simple case of developer embarrassment to catastrophic patient loss of life.

In response, they propose that app developers think about  this "two dimensional app space" that relies on a risk assessment coupled to a staggered regulation model.  That regulation can range from simple clinical self assessment to a more complex and formal approval process.

What's clear to the PHB is that hidebound mainframe entities like the Food and Drug Administration are no match for the app "ecosystem".  Rather than try to formulate a one-size-fits-all "not function as intended" model like this, maybe it should triage its oversight using the Lewis and Wyatt framework.

In addition, the PHB agrees with Lewis and Wyatt that safety is also a function of clinician input.  Docs and nurses can assess possible mistakes, their downside severity and the impact of all those variables.

The PHB couldn't have put it better:

".... many app developers have little or no formal medical training and do not involve clinicians in the development process and may therefore be unaware of patient safety issues raised by inappropriate app content or functioning."

Without the insights of seasoned real-world doctors and nurses, apps could end up with the same safety issues that are plaguing electronic health records, many of which were also developed with little regard to physician or nurse input. 

In other words, just because it's a "health" app doesn't mean its necessarily so.

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