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Protecting Patients.

There's an App for That

Medical apps may be running wild, but not if the FDA has its way.

August 06, 2013

Medical apps are everywhere. In 2011, the market was worth about $150 million, and some estimates say it’s grown to $716 million or more. As of 2013, there were 40,000 medical apps for tablets and smartphones. And they’re set to increase 25% annually over the next five years. They seem to span every medical issue, including:

  • SkinVision: monitors skin for moles, tracks exposure to UV rays.
  • Boston Children’s Hospital: access to lab results/ records, appointment management, GPS & directions, search doctors and programs, detailed hospital information.
  • Diabetes App: helps track blood sugar through monitoring personal factors, activity, food intake, medications, etc.
  • Diagnosaurus DDx: helps make personal diagnosis, organized by organ system, symptoms, etc.

 With growing concerns over patient safety, app effectiveness, and compliance to other laws, notably HIPAA, the FDA is stepping in. The Verge’s “Side effects may vary: the growing problem of unregulated medical apps” poses the question, “Can the FDA crack down on phony medical apps without killing innovation?”

The Diagnosis: Lack of Regulation.

Congress passed the FDA Safety and Innovation Act in 2012, giving them the green light to regulate medical apps. They started drafting guidelines in 2011, and hope to finish by the end of this year.

This issue came to attention both with the advent of apps, and due to failure to meet standards. The article highlights “AcneApp,” which claimed to cure acne, using light. This wasn’t the case, so the FTC (Federal Trade Commission) stepped in and fined them, and a similar app, AcnePwner, for “unsubstantiated scientific claims.” They were promptly pulled from app stores.

There’s no indication that anyone was hurt while using either of these.

Side Effects may Include…

The FDA’s primary role in this is to ensure consumer safety. However, it’s safe to say app development isn’t their forte. The outcomes of regulation, while potentially protecting users, could stifle the industry trying to help the very same people.

The Pros:

  • Consumer protection from fraud.
  • Elimination of apps that don’t treat the problem, are inaccurate or don’t consult professionals.
  • A safer and more efficient market for medical apps.
  • Potential protection of privacy.

The Cons:

  • Lack of expertise means criteria and judgment may not be fitting/ could be incorrect.
  • Fear of lawsuits and other negative ramifications.
  • Potentially stifled innovation as a result of improper/ rigid rules, or out of fear.
  • Outdated regulatory process means it could be time-consuming to obtain clearance (as of now, it takes the FDA ~6 months to approve a device that’s similar to an existing product, and ~20 months for a brand new one.)
  • It could also be very expensive: According to Stanford University, approval for a standard medical device costs between $24-$75 million.

Meaningful Treatment.

Regulating medical devices is meant to protect consumers. But both sides must understand one another and collaborate, to promote innovation while stopping bad products in their tracks. Developers may not understand complexities of the law, while the FDA might have questions of their own. For this reason, lines of communication need to remain open.

So far, the FDA has taken a collaborative approach. Proposed guidelines are available online, where the public can offer suggestions and comments. Whether those will be genuinely and intelligently considered is another story, but it’s a step in the right direction.

They’ve also been rather hands-off, but have sent warnings that certain products will need approval. Some developers anticipated this and contacted the FDA themselves. Lack of expertise or existing regulations could cause this approach, but only time will tell.

Finally, clarity is needed. Many laws are vague, long and complex, so they need to get it right before it’s published. For example, one common question is, “What about apps that don’t diagnose, but provide personalized information?” Distinctions like these need to be thoughtfully considered and spelled out.

Consumer safety should be the foremost consideration of both developers and FDA workers. Innovative and informed decisions are needed to combat worry and stagnation, in order to produce the best results moving forward.


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