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Apple App Store Toughens Guidelines For Health Apps

Posted on September 13, 2016 I Written By

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

In a precedent-setting move, Apple has released new guidelines for its iOS App Store which impose new limitations on health and medical app developers.  iMedicalApps contributor Iltifat Husain, M.D., who wrote a piece about the changed standards, said they contain “the most stringent language I have ever seen Apple used for the health and medical category of apps.”

According to Husain, highlights from Apple’s new developer guidelines include:

  • A warning that if an app could possibly cause physical harm, Apple could reject it
  • A warning that apps which provide inaccurate data or information that could be used to diagnose or treat patients will get increased scrutiny
  • A reminder that apps which calculate drug dosage must come from the drug manufacturer, a hospital, university, health insurance company or other approved entity. In other words, independent developers cannot post a medical app for drug dosages themselves.
  • A ban on marijuana-related apps
  • A ban on apps that encourage people to place their iPhones under a mattress or pillow while charging (such as some sleep monitors)

Historically, Apple has been relatively lax about hosting potentially dangerous health apps, Husain says. For example, he notes that apps purporting to measure a consumer’s blood pressure by using the iPhone’s camera and microphone tend to be quite inaccurate in their measurements, but that Apple had not screened them out.  Now things have changed for the better, Husain writes. “Apps [like these] would not get through the screening review process under Apple’s new guidelines.”

Husain argues that the new guidelines are more important than the FDA’s recently-updated guidelines on health apps: “There is no way the FDA can regulate the hundreds of thousands of health and medical apps and the updates made to them,” Husain writes. “The screening process is what has to change.” And given Apple’s market footprint and influencer status it’s hard to disagree with him.

At this point the question is whether Google will follow suit. After all, while the Apple app store hosted 2 million apps as of June, Google Play offered 2.2 million apps, according to one study, and as of February there were three Android users for every iPhone user. So If Google doesn’t put more stringent health app requirements in place as well, creators of dodgy health apps can still develop for Android and find a wide audience.

That being said, neither Google nor Apple are required to impose new restrictions on health apps, and are likely to be governed by commercial pressure more than medical appropriateness. Also, both parties are free to set any rules they choose, and uses might not be aware of important differences between the two sets of policies. In other words, if the goal is to protect consumers, relying on guidelines generated by app store hosts probably won’t fly over the long-term.

I’m not necessarily suggesting that the FDA or other regulatory body should come down on the app stores like a ton of bricks. That would be overkill, and as Husain notes, is probably beyond their capabilities.

But doctors in the know about apps might want to warn patients about their potential limitations, and offer some criteria as to what they can expect from health apps. After all, most consumers have experimented with one health app of the other, so even if the doctor doesn’t prescribe them, patients need to be educated about their options. So if you’re a mobile health savvy clinician reading this, consider increasing patients on these issues.

Steps In Integrating Patient-Generated Health Data

Posted on May 24, 2016 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.

As the number of connected health devices in use has expanded, healthcare leaders have grappled with how to best leverage the data they generate. However, aside from a few largely experimental attempts, few providers are making active use of such data.

Part of the reason is that the connected health market is still maturing. With health tracking wearables, remote monitoring set-ups, mobile apps and more joining the chorus, it might be too soon to try and normalize all this data, much less harvest it for clinical use. Also, few healthcare organizations seem to have a mature strategy in place for digital health.

But technical issues may be the least of our problems. It’s important to note that providers have serious concerns around patient-generated health data (PGHD), ranging from questions about its validity to fears that such data will overwhelm them.

However, it’s possible to calm these fears, argues Christina Caraballo, senior healthcare strategist at Get Real Health.  Here’s her list of the top five concerns she’s heard from providers, with responses that may help put providers at ease:

  • Fear they’ll miss something in the flood of data. Add disclaimers, consent forms, video clips or easy-to-digest graphics clarifying what consumers can and can’t expect, explicitly limiting provider liability.
  • Worries over data privacy and security: Give consumers back some of the risk, by emphasizing that no medium is perfectly secure, including paper health records, and that they must determine whether the benefits of using digital health devices outweigh the risks.
  • Questions about data integrity and standardization: Emphasize that while the industry has made great process and standardization, interoperability, authentication, data provenance, reliability, validity, clinical value and even workflow, the bottom line is that the data still comes from patients, who don’t always report everything regardless of how you collect the data.
  • Concerns about impact on workflow: Underscore that if the data is presented in the right framework, it will be digestible in much the same way as other electronic medical data.
  • Resistance to pressure from consumers: Don’t demand that providers leverage PGHD out of the gate; instead, move incrementally into the PGHD management by letting patients collect data electronically, and then incorporate data into clinical systems once all stakeholders are on board.

Now, I’m not totally uncritical of Ms. Caraballo’s article. In particular, I take issue with her assertion that providers who balk at using PGHD are “naysayers” who “simply don’t want to change.” While there are always a few folks fitting this description in any profession, the concerns she outlines aren’t trivial, and brushing them off with vague reassurances won’t work.

Truthfully, if I were a provider I doubt I would be comfortable relying on PGHD, especially biometric data. As Ingrid Oakley-Girvan of Medable notes, wearables giant Fitbit was hit with a lawsuit earlier this year alleging that its heart rate monitoring technology is inaccurate, and I wouldn’t be surprised other such suits arise. Digital health trackers and apps have transitioned from novelty to quasi-official medical device very quickly — some might say too quickly – and being cautious about their output just makes sense.

Nonetheless, PGHD will play a role in patient care and management at some point in the future, and it makes sense to keep providers in the loop as these technologies progress. But rushing them into using such data would not be wise. Let’s make sure such technologies are vetted before they assume a routine role in care.