Lawmakers Unveil Framework for Medical Innovation Legislation
December 1, 2014 in News
Last week, lawmakers on the House Energy and Commerce Committee released a framework for an upcoming bipartisan package of legislation aimed at increasing medical innovation, in part by expanding health IT, mHealthNews reports (Wicklund, mHealthNews, 11/25).
Details of Framework
Committee Chair Rep. Fred Upton (R-Mich.) and committee member Rep. Diana DeGette (D-Colo.) said they intend to release a discussion draft of the “21st Century Cures” legislative package in January 2015.
The package would focus on six priority areas:
- Cultivating the future of science, including by encouraging young scientists;
- Further incorporating the patients’ perspectives into the regulatory process;
- Investing in advancing research;
- Modernizing clinical trials;
- Providing incentives for developing new devices and drugs to treat unmet medical needs; and
- Supporting health IT by furthering the use of new medical technologies and data sharing (Gold, “Morning eHealth,” Politico, 11/25).
AMIA Calls for HIPAA Changes in Package
In related news, the American Medical Informatics Association last month sent Upton a letter calling for the legislative package to include amendments to HIPAA that would allow medical researchers to access health records without patient consent, Modern Healthcare reports.
Under a 2002 revision to HIPAA, “covered entities” do not have to obtain patient consent prior to sharing health records for the purposes of “treatment, payment and other health care operations.” AMIA is requesting that lawmakers include research as an additional exemption (Conn, Modern Healthcare, 11/26).