The past couple days of following the House Energy and Commerce Subcommittee hearings on mobile health regulation has forced me to clarify my thinking about regulation of this sector.
Since the US Food and Drug Administration has already given 510(k) clearance to 75 apps without too much complaint I don’t see why it shouldn’t continue doing that. The hearings this week established the average amount of time it takes is 90 days to 1.5 years, which doesn’t seem too burdensome and apps that are helping physicians and other health care professionals to take action on the kind of treatment patients need should be held to a higher standard than an app that tells you how many calories you’ve burned and how far you have run/walked/ dragged your ass. If an app wants to tell me whether I should be worried about skin cancer, I’d want to know that it has had to prove that it’s effective and that I could trust it.
I do think Ben Chodor has the right idea with Happtique’s certification program for mobile health apps, a program he painstakingly developed in the past year with help from medical societies, health care professionals, medical societies and regulatory agencies, including the FDA, Federal Trade Commission and Federal Communications Commission. It is more like an accreditation pathway that hospitals can sign up for and theoretically would give some additional credibility to developers.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
It’s difficult to predict when the US Food and Drug Administration will act so in the absence of anything else, Happtique at least does the job of establishing a safety standard. If developers want to build consumer confidence and want health care facilities to trust their apps covering vital signs to medical education to to be safe to use help them make informed decisions on health to be considered for use by physicians to treat patients then there needs to be a process in which those apps can be tested and developers can respond to any questions the certification board has.
I do think that the regulatory oversight should include apps that are transmitting or receiving a signal from a medical device should also be treated as medical devices and regulated accordingly and that was included in the FDA’s draft guidance. Here’s a useful link to a story we published a couple of years ago outlining the kind of apps the FDA believes it should regulate in its draft guidance.
Since I seriously doubt anyone believes the FDA regulation of mobile health apps would be significantly different than what was spelled out in the draft guidance, the hearing subtext has been a debate about the 2.3 percent medical tax provision of the Affordable Care Act. Some witnesses and representatives seem to believe that most mobile health companies are so small that applying a tax to those with apps classified as medical devices will kill innovation and, just as importantly, jobs. But there are small medical device companies too. I think there are two reasonable and fair ways to reform this provision. Either apply the tax to companies that are generating revenue at a significant enough level so that it won’t kill their business or eliminate the tax altogether. If mobile health app supporters think the tax will kill innovation, then how would that be any less true of the smaller device companies?
Another idea that has merit was one Rep Mike Honda (D-15th) proposal to create an Office of Wireless Health at the FDA that would provide a “consistent, reasonable and predictable regulatory framework on wireless health issues.” But until the FDA shifts its guidance to regulations, it is difficult to say whether Honda’s proposal would be needlessly bureaucratic.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
[Images of Money photo from Flickr user]
