Report Recommends Health IT Changes for 21st Century Cures
July 28, 2015 in News
On Monday, the Bipartisan Policy Center released a report with recommendations to improve the 21st Century Cures Act (HR 6) and accelerate medical innovation, Modern Healthcare reports (Ross Johnson, Modern Healthcare, 7/27).
Earlier this month, the House voted 344-77 to advance the 21st Century Cures Act, which includes several health IT and interoperability provisions.
The Senate is writing its own version of the bill, and it is not yet clear what a compromise measure would include. Bill supporters in the House hope to bring the compromise measure to a vote in the fall (iHealthBeat, 7/10).
The report highlights four policy issues that seek to reduce the time and cost associated with developing new drugs and medical devices (Modern Healthcare, 7/27).
Under the policy issues are several health-IT related actions. For example, BPC recommended that Congress improve interoperability among health IT systems as a way to improve the medical product development process (BPC release, 7/27).
The report, among other things, recommended that Congress require:
- The federal government to adopt standards for health IT, including those for electronic health records and accurate patient data matching;
- Federal agencies to annually report on their compliance with such standards; and
- Testing and validation of standards adoption and systems interoperability.
According to the report, the Office of Management and Budget and the Office of the National Coordinator for Health IT should be responsible for identifying the standards, and the standards should be published every 12 months (BPC report, July 2015).
Meanwhile, the report recommended that Congress clarify regulatory authority, including that related to health IT (BPC release, 7/27). Specifically, the report stated Congress should:
- Make it clear that health IT should not be regulated as a medical device by FDA, except for cases when the HHS secretary determines a product poses a significant risk to patient safety;
- Require HHS to allow independent entities to develop voluntary standards, measure compliance and facilitate voluntary patient safety data reporting as a way to improve the use of health IT; and
- Require HHS to extend privacy protections to health IT developers in order to help them report and receive patient safety data (BPC report, July 2015).
Former Senate Majority Leader and BPC Senior Fellow Bill Frist (R-Tenn.) said, “It’s clearly time to take action to significantly advance medical innovation in the [U.S.]” (Modern Healthcare, 7/27).