International Guidance on Regulating Software as a Device Could Influence U.S. Oversight, in Bloomberg BNA’s Health IT Law & Industry Report

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 Guidance on Regulating Software as a Device Could Influence U.S. Oversight."

Following is an excerpt:

Normally, an international effort to achieve harmonization produces only minimal success because each of the individual nations has a well-established regulatory framework that they are reluctant to change. International harmonization, at best, means aggregating the individual country level requirements. And, by itself, the international document has no legal effect beyond influencing the policy decisions of the individual countries.

But, here, the IMDRF is actually ahead of the individual national efforts in many cases. The U.S., the U.K. and the Australians have all produced basic guidance on mobile medical apps and certain other types of software. However, by and large, most of the individual countries have not yet figured out exactly how to regulate this space. So, it is significant to have the major developed and developing nations gather together to produce a consensus position. That consensus position is much more likely to then be adopted by the individual nations, at least in some measure.