Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled “International Regulators Focus on Medical Software, Including Apps.”
Following is an excerpt:
I’ve always found the saying, “Be careful what you wish for; you might just get it” to be rather condescending. In a way it suggests that we are too stupid to manage our own affairs. But like any popular saying, it probably has a kernel of truth.
Frankly, I’m a little nervous about a request made by industry for international medical device regulators to focus on standalone software, including mobile medical apps. At the request of an international trade group, on March 21, 2013, the International Medical Device Regulators Forum (IMDRF) decided to pursue harmonization of the regulatory approach to standalone medical device software. Standalone software in healthcare, as most people use that term, would include mobile medical apps, clinical decision support software, electronic health records and any other software used in healthcare that does not drive a medical device (hence it stands alone.)