Congress Seeking to Limit FDA Oversight of Low-Risk Software

Posted in Regulatory and Compliance by Stephen Levy on February 27, 2014

The drumbeat to limit FDA's regulatory authority over various software systems is growing.

Many interested parties are worried that FDA will act to regulate Electronic Medical Records (EMRs) and Electronic Health Records (EHRs) with the same rigor that is applied to the software running a radiation therapy machine.

Boston Globe reporter Tracy Jan spoke with Dan Haley, vice president for government and regulatory affairs of Athenahealth (Watertown, MA), a health information firm. “Right now, the FDA has the authority to regulate all of health IT,” Haley said. “They say they exercise discretion to pick and choose which technologies they regulate. From our perspective, that is just not a tenable state of affairs.”

In her article, Jan continues, “Backers of FDA regulation say digital records systems sometime contribute to prescribing errors and other patient mix-ups that can have dangerous, even fatal, consequences. Bad or missing data in a patient’s computer record, for instance, can lead to catastrophic medication errors.

“But the health care industry, including many top hospitals as well as manufacturers of the systems that manage digital records, want looser regulation. They contend that submitting to FDA safety reviews would slow the pace of innovation and make software upgrades difficult.”

Find out more about the medical device industry and medical device components at BIOMEDevice, March 26-27, 2014 in Boston.

In October, the bipartisan Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act was introduced in the House of Representatives. This bill seeks to amend Section 201 of the Federal Food, Drug, and Cosmetic Act, limiting FDA's authority to regulate medical software. It would also provide guidance to FDA regarding its mobile medical app regulations.

The Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014 is the Senate's answer to the SOFTWARE Act. Sponsored by Senators Deb Fischer (R-NE) and Angus King (I-ME), the bill “seeks to develop a more specific regulatory framework for health IT that promotes innovation and job creation while protecting patient safety.”

The PROTECT Act of 2014 (the date is necessary because there have already been a few Protect Acts in the past) would clarify FDA's regulatory process for healthcare IT to make sure it primarily focuses on technologies that pose the most health risks, and ensure that low-risk products are not the focus of oversight. It would also exempt certain categories of low-risk clinical and health software, such as EMRs and wellness apps, from the medical device tax.

Whichever of the two bills becomes the basis for the final law, we just hope the legislators will decide one important issue: Are those digital patient files supposed to be called Electronic Medical Records, or Electronic Health Records? The two are often used interchangeably but the government insists there is a difference between the two.

Stephen Levy is a contributor to Qmed and MPMN.