Does the mHealth industry need regulation, or just guidance?
Of all things, we need common sense. HIPAA truly is industry-wide guidance. For instance, the overall intent of HIPAA is to protect patient-identifiable information. The language is gray and requires interpretation, and the point is to put safeguards in place that protect PHI. However, I interpret the FDA providing "guidance" - as opposed to strict regulation - in a similar vein as the intent of HIPAA: to provide a platform to abide by, without strict regulation (outside of the necessity of specific high-risk medical devices). There are, of course, significant penalties in place for HIPAA breaches, a turning point that I hope that mHealth doesn't reach.
One of the most compelling things I heard at last week's Energy and Commerce hearings in Washington D.C. was the testimony of Ms. Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, on what the FDA policy does not plan to regulate.
"Just as importantly as what our policy proposes is what our policy does not propose," she said. "It would not regulate the sale or general consumer use of smartphones or tablets. It would not consider entities that exclusively distribute mobile medical apps, such as the iTunes App Store or the Android market, to be medical device manufacturers. It would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA. It would not require mobile medical app developers to seek agency re-evaluation for minor, iterative product changes. And it would not apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system."
Can regulation influence innovation? By all means. Kudos to Rock Health for the release of FDA 101: A Guide to the FDA for Digital Health Entrepreneurs.
Wi-Fi has also set a precedent for how regulation can influence innovation. This from a 2004 article in The Economist: "Wi-Fi would certainly not exist without a decision taken in 1985 by the Federal Communications Commission (FCC), America's telecoms regulator, to open several bands of wireless spectrum, allowing them to be used without the need for a government license. This was an unheard-of move at the time; other than the ham-radio channels, there was very little unlicensed spectrum. But the FCC, prompted by a visionary engineer on its staff, Michael Marcus, took three chunks of spectrum from the industrial, scientific and medical bands and opened them up to communications entrepreneurs. Though the 1985 ruling seems visionary in hindsight, nothing much happened at the time. What ultimately got Wi-Fi moving was the creation of an industry-wide standard." Today, Wi-Fi and spectrum are much sought-after commodities.
And yet one more notion of industry influence on standards setting is UL (Underwriter's Laboratory) certification. UL operates under its own authority as an independent, not-for-profit, nongovernmental organization. However, it has set the standard for the industry and provides assurance to consumers of the integrity of their electrical purchases. Have you ever purchased an extension cord to wire your holiday lights? Did you notice the "UL" sticker that's wrapped around the cord?
If all players in the mHealth space adhered to guidance, if they actively engaged and leveraged a compendium of best practices and industry recommendations, this would be the least obtrusive and provide the best opportunity to not impede innovation and progress to date.
Innovators and stakeholders require appropriate and predictable approaches to low-risk applications in the healthcare market. By ensuring clarity of regulations through guidance in a technologically fast-moving space, the FDA in collaboration with other key mHealth stakeholders will ensure that providers and patients will have assurance of the integrity of available mobile technologies and mHealth application.
Regulation? Guidance? There's a difference, and it counts. And it will certainly change the way the mHealth game is played.
David Collins, MHA, CPHQ, CPHIMS, FHIMSS, is the senior director of mHIMSS, the mobile initiative of HIMSS. He has been on more than 30 site visits assessing HIMSS Davies Award candidates and is past liaison to the HIMSS Patient Safety Quality Initiative. He is a 2012 Baldrige Award Examiner.