Of late, the FDA has been looking at into how it will regulate health IT generally, and EMRs especially, under the authority of the Food and Drug Administration Safety Innovation Act of 2012. This, of course, has the vendor community very nervous, as they’re not eager to have an agency as powerful as the FDA breathing down their neck.
In an effort to soften the blow somewhat, the chairman and CEO of HIMSS have written a letter to HHS outlining why health IT products, especially EMRs, have unique functions and requirements.
In the letter, they argue that any regulatory efforts that are made should have the following characteristics:
• Holistic Approach: Any regulatory or oversight framework should recognize that health IT is part of a complex patient care ecosystem involving providers, product developers, vendors, a wide array of use cases, and consumers as patients and caregivers.
• Shared Responsibility: The safety and efficacy of health IT as it fits within the patient care
system can be enhanced through non-punitive surveillance and reporting systems based on mutual trust and shared responsibility by all participants.
• Clear Oversight Direction: Clear and consistent guidance regarding proposed regulatory and/or oversight activity is essential to ensure that health IT can continue to provide the innovation and tools necessary to achieve the patient safety and quality improvement goals, and cost efficiencies sought by all stakeholders.
• Role of Intended Use/Functionality: Regulation and oversight actions should be based on the intended purpose and intended user of a particular product or service.
Cutting a nice wide path for EMRs and related clinical data systems, HIMSS argues that health IT products largely used for transmission, storage and management of data should not be considered medical devices. The execs also argue that there’s a big difference between products which are “integral to the functioning of a medical device,” and those that communicate with such devices. (While there’s definitely a move on to integrate EMRs and medical devices, progress has been scant to date.)
We’ll see how successful HIMSS was at shaping the FDA’s expectations next year, when the agency releases a joint report outlining its strategy in cooperation with the FCC and ONC.
In the mean time, the three agencies have formed a workgroup under the ONC’s HIT Policy Committee which will provide recommendations to the Health IT Policy Committee. If you’re as worried as HIMSS is, and there’s no reason not to be, the workgroup may offer a chance to make your voice heard. Getting involved, or at least commenting on draft report docs, is probably a good idea.