Democrats urge FDA to include civil rights, disability and ethics advocates on digital health committee  

A group of Democratic senators asked the Food and Drug Administration (FDA) to include members with backgrounds in civil rights, medical ethics and disability rights on the agency’s new Digital Health Advisory Committee.

The FDA announced the nine-member committee in October to help explore issues related to digital health technologies, including artificial intelligence (AI) and wearable health technology. The committee will advise the FDA on issues related to the technology.  

The Democrats, led by Sen. Ed Markey (D-Mass.), urged FDA Commissioner Robert Califf in a Tuesday letter to include at least one voting member with a background in civil rights, one voting member with a background in medical ethics and one voting member from a disability rights organization.  

The senators underscored the need for members with those backgrounds in order to mitigate concerns about bias posed by the use of algorithms and other health technology while also acknowledging that the technologies could also improve conditions such as patient outcomes, cost reductions and health provider retention. 

“The civil rights and medical ethics implications of [digital health technologies] are manifest. It is essential that voices with a background in civil rights, in medical ethics, and from a disability rights organization are part of the Digital Health Advisory Committee, in order to assist the FDA as it develops regulatory guidelines that will determine the safety and efficacy of these products. It is also crucial that the voices of those who will be using these tools are consulted when developing these regulations,” they wrote.  

According to the FDA’s announcement, the committee should be “fully operational” in 2024.  

The letter was also signed by Sens. Bernie Sanders (I-Vt.), Bob Casey (D-Pa.), Amy Klobuchar (D-Minn.), Tammy Duckworth (D-Ill.) and Alex Padilla (D-Calif.).