Disruptive Technology | Healthcare Policy & Reform

FDA’s “Enforcement Discretion” Draws Health IT Entrepreneurs to Capitol Hill


Bystanders in the nation’s capital on Monday afternoon witnessed a rare sight. A group of 20 health IT entrepreneurs left their natural habitats — the basements and garages where they typically code day and night to fix health care — and ventured into the unfamiliar halls of Congress to deliver an important message. Convened by athenahealth’s More Disruption Please (MDP) innovation initiative, these upstart CEOs had a simple request: make the rules of the game clear by fixing the Food and Drug Administration (FDA) policy of exercising “enforcement discretion” over most health IT. What this means is that, though the FDA has overly broad jurisdiction to regulate all health IT, that flaw can be remedied through the FDA’s exercise of its discretion to not enforce that authority (i.e., enforcement discretion).

The MDP entrepreneurs are responsible for bringing innovative solutions to providers and patients. Their technologies do amazing things: allowing patients in rural areas to see physicians via their smartphones, helping couples use data to improve their chances to conceive, and giving health care providers access to cutting-edge clinical protocols. The creators of these forward-thinking solutions took a day away from their work to make sure members of Congress understood that innovations like these need the right regulatory environment to flourish.

Regulation and innovation can be at odds. But sometimes, regulation can provide the certainty and clarity that an industry needs to move forward. Regulatory uncertainty, on the other hand, will always be at odds with innovation; the former destroys all hope of the latter. No one wants to make a substantial investment in an industry if there is a reasonable chance that the underlying rules of the game will change a few years down the road, imposing unforeseen costs that eat into the return on investment. This fear of an ever-shifting foundation is why so many More Disruption Please CEOs joined athenahealth on Capitol Hill with this will to caution against the increasing use of and reliance on a policy used by the FDA called “enforcement discretion.”

When FDA officials state they have no present intent to regulate the innovations that our MDP partners develop, I believe them. But those people will not work at the FDA forever, and enforcement discretion does nothing to provide the industry with certainty that future FDA officials will not take a different position when it comes to regulating health IT.

To be clear, this effort is not about avoiding regulation. It’s about an assurance that the rules today will be the rules tomorrow. A changing regulatory landscape would be an unwelcome distraction for larger companies like athenahealth — and our even larger peers — but the health IT entrepreneurs that took to the Hill on Monday want to be very clear that it carries far more impact for them. Unsteady regulation can mean closing the doors for good on smaller, start-up businesses that are currently operating on razor-thin margins. That risk of “waking up dead” from the stroke of the regulatory pen is what will ultimately keep innovators and investors looking to focus their talent and resources on industries with more certainty.

The MDP CEOs were supportive of the direction taken by two pieces of legislation, the SOFTWARE Act and the PROTECT Act. Both would limit the FDA’s jurisdiction over health IT, in line with what the agency has proposed to do with enforcement discretion. Legislation is the only way to provide innovators with the regulatory certainty they need to continue to develop cutting-edge technologies that can bring previously unseen value to the industry.

We are so thrilled to be able to convene top-notch innovators and bring their voices to Washington, DC. The health care industry needs plenty more crazy entrepreneurs — but that means the policymakers who write the rules of the game need to hear from more than just the large, incumbent players.

If you’d like to see more advocacy efforts on behalf of our MDP partners in the future, let us know by commenting or tweeting me @s_zaremba.