Software as a medical device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” SaMD is developed at a much faster pace than traditional medical devices, and may require frequent updates, as opposed to hardware devices that typically are updated every few years. While SaMD and medical devices are clearly different and evolve at completely different paces, the same regulatory approval process currently applies to both types of technology. Using the same process for both is akin to forcing a square peg into a round hole – it is not going to work because one size does not fit all, especially in healthcare.
This is a watershed moment in healthcare. New technologies are constantly in development to help treat and prevent previously incurable conditions, and improve current processes. From leadless pacemakers to mobile applications that advance telehealth access, digital innovation is at an all-time high. The problem is that our current speed of regulatory approval for these innovations simply cannot keep up.
While many groundbreaking technologies are being created, their full promise is not being realized because they are not being approved quickly enough to be implemented and adopted by health systems. The FDA regulatory process has long been a matter of contention. However, now that the rate of innovation is increasing, things need to change accordingly. By working together to streamline this regulatory process, technology will arrive to the market faster and propel the healthcare industry forward.
There is broad agreement that the U.S. healthcare system must focus on improving overall care quality and cost efficiency. The pressures imposed on the system by the Affordable Care Act make this need abundantly clear. The Healthcare Leadership Council (HLC) is offering ways to transform healthcare by proposing six reforms developed by senior leaders from all sectors, engaged patient groups and key industry voices. The action areas include health information interoperability; changes to federal anti-kickback and physician self-referral (Stark) laws; health information flow improvements focused on patient privacy laws and regulations; FDA (Food and Drug Administration) reforms; comprehensive care planning; and medication therapy management.
I’ve recently had the opportunity to travel to our nation’s capital a couple of times through our relationships with trade associations (The App Association [ACT], an international software advocacy and educational organization) and partners such as athenahealth. These are always whirlwind days, packed with meetings with Congressional staffers, members of the Office of the National Coordinator (ONC) and regulators from the FDA, FCC and others.
For months now, I’ve called for the FDA guidance to clarify medical device regulations as they apply to mHealth. While most vendors would shy away from stricter regulations and standards, I believe that FDA regulations are necessary for mobile applications and websites to ensure patient safety and privacy in this emerging space. This week my calls were answered, with the release of the FDA final guidance for mobile medical applications.
The long-awaited final guidance is a critical milestone for mHealth, and is largely aligned with what was anticipated based on earlier released drafts. But it’s what happens now that guidance is in place that will truly shape the industry. It’s critical for payers, providers and, ultimately, consumers to ensure that they are being broadly implemented.
As you may have guessed from the title of this post, my opinion is not widely held among my fellow mHealth business leaders. Most think it is counter-intuitive to argue that the FDA must be a key player in the development – and regulation – of the mHealth ecosystem. We all know the real reasons.
The House Energy and Commerce Committee’s recent questions to FDA are seeking much-needed clarification of the agency’s policy of regulating certain mobile medical apps as medical devices. I’m very pleased to see the FDA responding to attempts to clarify the “gray area” of the guidance it issued in July 2011. Following three days of hearings last week on rules for these products – including the impact of FDA oversight and the potential for new taxes – I hope the FDA will take the following patient safety issues into consideration: Continue reading