A bill circulating the halls of Congress would limit the FDA's oversight of electronic health records and clinical decision support software, but may not have much practical effect since the agency already limited its role in the regulation of software in a June draft guidance.
According to sister publication FierceHealthIT, the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act would exempt five items from a prior law: software intended for administrative support, products unrelated to clinical treatment of a disease or disorder, electronic health records, software intended to present data prior to analysis and software for displaying and printing information.
Unlike other monstrous healthcare bills, this one is only four pages long, though that could change if it ends up being formally introduced to Congress. When that will happen is unknown.
"FDA would not regulate software if the user can see through the software to the original data and clinical intelligence and make the decision for themselves," Epstein Becker Green health attorney Brad Thompson told FierceHealthIT in an email. "If the software is simply doing what software does best, which is retrieving data and doing calculations, but the user has all of the information at his or her fingertips, the decision-making of the user is really governed under the practice of medicine and is not something into which the FDA should intrude."
In a June draft guidance, the FDA essentially followed Thompson's advice, by invoking that infamous regulatory term or art "enforcement discretion" and saying it would not enforce compliance guidelines for medical device data systems, medical image storage devices, and medical image communications devices.
Medical device data systems are "are off-the-shelf or custom hardware or software products that transfer, store, convert format, and display medical device data without modifying it, and without controlling or altering the functions or parameters of any connected medical devices," explained FDA senior policy advisor Bakul Patel in a June blog post on FDAVoice.
However, the draft guidance does not mention electronic health records, so that part the of the bill could be significant. The law would also remove FDA's discretion to regulate those other products even if it so desired.
The bill does not exempt software or related products are that are a component or accessory, or are "regulated or subject to regulation as a device classified as a Class II or Class III device." That meshes with the FDA's enforcement discretion policy to limit enforcement of its regulations to potentially risky mobile medical apps that perform the same function as a medical device.
- read the FierceHealthIT article
- here's the proposed legislation (PDF)
- read the FDA draft guidance