Last April, President Obama’s administration issued the FDASIA Health IT Report, in which it made recommendations to Congress about how the FDA should regulate various types of Health Tech devices. Now, a group of 58 technology and health companies and associations have banded together to write a letter to the U.S. Congress urging the legislators to codify those recommendations in law to remove doubts about what is and is not permitted. The group includes IBM, Oracle, Athenahealth, and the American Association of Diabetes Educators.
The recommendations essentially separate products and services into three groups, based on the perceived risk to patients. For those devices that pose little or no risk, the industry group asks that they continue to be unregulated. If the device or service is high risk such as playing a role in delivering a diagnosis of a disease or condition, it should remain under the close oversight of the FDA. The third group of devices or systems that pose some lesser risk should be regulated based on industry standards and private certification to ensure their safety and reliability.
Whether or not Congress will act on this request remains t be seen. Clearly, the uncertainty of not knowing whether a given product or service will require rigorous FDA approval or not will likely have a chilling effect on the development of new offerings. On the other hand, it remains to be seen whether or not these devices can be neatly parsed into the three separate categories as described in the FDASIA report. This well could be an example where “act in haste, repent at leisure” may apply.