Skip to main content

Nation’s clinical informatics professionals offer several new areas where Congress can advance digital health and biomedical research

In comments sent to Reps. Diana DeGette (D-CO) and Fred Upton (R-MI), the American Medical Informatics Association (AMIA) strongly supported the idea of a follow-up to the 21st Century Cures Act (Cures 2.0), while also highlighting several specific policy areas that a “Cures 2.0” should address.

Just before Thanksgiving, DeGette and Upton, co-authors of the original 21st Century Cures Act, released their broad vision for a health law to improve patients’ access to digital health products and new medical therapies. A major goal of this legislation, they wrote, would be to speed up coverage of FDA-approved drugs and devices by Medicare, Medicaid, and private payers. The authors were also seeking to increase the use of real-world evidence (RWE) in FDA’s regulatory approval processes and improve family caregivers’ health literacy. Upton and DeGette asked the public for specific items to consider under the priorities they outlined, as well as ideas for reforms not included in their vision.

AMIA was strongly supportive of the vision’s intended focus areas, but also outlined several more areas that are ripe for reform. AMIA urged the lawmakers to pursue updated data privacy policies for the 21st Century, which the group said should support individual privacy and promote individual autonomy over data not only covered by the HIPAA privacy rule, but also those collected by non-covered entities.

The group also called on Congress to statutorily address data sharing requirements for NIH grants, pointing to the recent updated draft of the NIH Policy for Data Management and Sharing that AMIA said did not go nearly far enough in breaking down long-standing data silos in biomedical research. To further address data silos, AMIA also encouraged Congress to, once again, take up a bill the House passed in 2015 that would include a number of provisions focused on “accessing, sharing, and using health data for research purposes” within HIPAA’s definition of health care operations.

AMIA additionally highlighted its support for the goals of the FDA Digital Health Software Precertification (Pre-Cert) Program pilot, but asked the lawmakers to grant the agency new regulatory authority to pursue the pilot. AMIA argued that such authority would both strengthen the program and oversight.

Finally, AMIA reiterated its support for repealing of the ban on using federal funds to promulgate or adopt a national patient identifier. While the House already repealed this ban, AMIA said a Cures 2.0 bill would be another good opportunity to address this impediment to patient safety and privacy.

 “Even while the work of implementing 21st Century Cures continues, we have seen that this space moves fast,” said AMIA Board Chair Peter J. Embi, MD, MS, FACP, FACMI, FAMIA. “As we did the first time around, AMIA stands ready to offer our expertise in shaping these vital reforms for the 21st Century.”

Click here for AMIA’s full response to Reps. DeGette and Upton.


AMIA, the leading professional association for informatics professionals, is the center of action for 5,500 informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in assessing the effect of health innovations on health policy, and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.