SOFTWARE Act Gets Mixed Industry Response

The Sensible Oversight for Technology which Advances Regulatory Efficiency Act, introduced in the House of Representatives last week, has been met with mixed reactions.

The SOFTWARE Act would modify the language in the Federal Food, Drug and Cosmetic Act to introduce three new classes of health IT software to face different regulatory oversight. Medical software, defined as software "intended to be marketed to directly change the structure or any function of the body of man or other animals," would be subject to Food and Drug Administration oversight. Clinical software, defined as software used in healthcare settings by clinicians, and health software, software not used directly in patient care, would not be subject to regulation.

The bill aims to strike a balance between ensuring patient safety and fostering innovation. "This bill would provide the FDA with the tools it needs to effectively protect consumers who use high risk technologies, while allowing the innovation of low risk technologies to continue without being caught up in the expensive and time consuming FDA approval process all while protecting patient safety," said Representative Marsha Blackburn (R-Tenn.), one of the bill's sponsors, in a statement.

The Software & Information Industry Association has come out in support of the bill. "The SOFTWARE Act takes necessary steps to establish regulatory framework for medical software without compromising safety," said SIIA President Ken Wash in a statement. "Specifically, the SOFTWARE Act would create a bright line that delineates when the FDA should regulate medical software, and when it should not, calling for FDA regulation of software only when it has the ability to change the end user's current state of physiology with limited or no opportunity for informed human intervention."

However, the mHealth Regulatory Commission has expressed concern over several aspects of the legislation. In a letter to Rep. Blackburn this summer commenting on the then-drafted legislation, the coalition expressed concern the bill would create confusion, is inconsistent with the intent Food and Drug Administration Safety and Innovation Act and could go further than necessary with deregulation.

More Articles on the FDA:

A Disrupted Landscape: The New Medical Device Industry
Personalized Medicine is the Future, But Will it Limit Drug Discoveries?
To App or Not to App: Patients' Growing Use of Medical Apps

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