A revision of the Safety and Innovation Act points towards tighter regulation in the Mobile Healthcare Application market, however a firm hand can quite often be just what the Doctor ordered...
Earlier this week President Obama signed off on S.3187, the “Food and Drug Administration Safety and Innovation Act”. The signing was seen as a turning point in the development of treatments for rare disease patients, however section 618 has also caught some attention.
“SEC. 618. HEALTH INFORMATION TECHNOLOGY” has seemingly paved the way for tighter regulation in the mobile medical applications market within the US.
The signing comes a year after the FDA released its initial guidelines for the healthcare app industry, which outlined stringent controls for the development and release of “true” healthcare apps. The updated Section 618 has called for a number of governing bodies to draft a report within 18 months of the legislation becoming law, to provide an ‘appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications that promotes innovation, protects patient safety and avoids regulatory duplication.’
While this means the FDA haven’t quite taken control of the market just yet, they will be involved in drafting the report, and the legislation doesn’t preclude them from publishing their own recommendations in the meantime.
Other agencies involved in drafting the report will be the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission. The Secretary of Health and Human Services will author the report, acting through the Commissioner of Food and Drugs, while the final document will be published on the FDA, the FCC, and the ONC websites.
If you’re an app designer looking to build the world’s next great calorie-counter you needn’t worry, the upcoming guidelines as outlined in Section 618 will apply specifically to “mobile medical applications”, that is to say those apps which could be considered an auxiliary to already-regulated devices, or that could be seen to transform your smartphone into a medical device itself - for example a mobile blood glucose testing kit.
With growing investment in, and discussion around, mobile healthcare solutions, the final decision on the amendment to the Safety and Innovation Act could be seen as stifling by some. After all, the medical mobile application market – an industry that didn’t exist as little as five years ago – is already worth an estimated $718 million and rising.
One of the primary concerns of these recent developments seems to be the actual process of getting your app approved. The US Government Accountability Office states that on average the FDA takes six months to approve a new device which is similar to one already on the market, and can take up to 20 months to approve a completely new device.
This may sound like an eternity but lets add a little perspective, consider the time taken to develop a new drug versus the time taken to develop a new piece of software (or in this case an app), while 20 months for approval may sound like a deal breaker, drug developers have been faced with significantly longer timescales for decades. Even factoring in the time to develop an app, there is still a marked difference in time to market.
Another concern is the cost of approval. According to a Stanford University Report, the current cost of 510(k) FDA approval for a medical device stands somewhere in the region of $24 - $75 million. Some have taken this as an indication that we could see similar costs for mobile app development, and while I’d admit that $26 million USD for app approval is a bitter pill to swallow (event by current Apple App Store standards) I also see it as highly unlikely that costs will be anywhere near this figure.
While it goes without saying that there will be a cost involved, it would be reasonable to assume that the cost will be indicative of the function and technology being put forward.
While some might accuse the FDA of acting with a heavy hand, or question their role in regulating this industry at all, it’s important to remember that we’re not talking about any old “wellness” app, which remains largely unaffected; we’re talking about applications which are themselves used as an extension of treatments and medical devices prescribed by doctors. In other words: apps which can have a direct influence on the health and wellbeing of the general public.
What can we take away from this? The FDA (and by extension the US Government) are beginning to wake up to the fact that patient care and patient-doctor relationships are changing in a lasting and fundamental way. Such change requires reflection and further scrutiny to ensure best practice and a positive outcome.
Tighter regulation in the mobile sector was always going to happen, it’s an inevitability that cannot be ignored, it was a question of when rather than if.
Had the FDA and Congress done nothing, critics would have decried both bodies for failing to protect the public.
Which would you prefer? Too much regulation too soon? Or too little too late?
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