FDA Issues

The FDA issued draft guidance which states that the agency will not enforce regulations on computer medical device data systems (MDDSs) used to store, display or collect medical data because they pose a low risk to patients. The agency also released two other draft guidance documents for drug and device manufacturers relating to the presentation of risk-benefit information and correcting third-party misinformation on social media.

Upcoming Health-Related Hearings and Markups

House Energy and Commerce Committee: will hold a roundtable titled “21st Century Cures Roundtable: Digital Health Care;” 10:00 a.m., 2123 Rayburn Bldg.; June 24.

House Energy and Commerce Oversight and Investigations Subcommittee: will hold a hearing titled “Medicare Program Integrity: Screening Out Errors, Fraud, and Abuse;” 10:00 a.m., 2123 Rayburn Bldg.; June 25.

Senate HELP Committee: will vote on legislation to reauthorize federal autism programs, a bill to amend the Employee Retirement Income Security Act of 1974, and nominations; 10:00 a.m., 430 Dirksen Bldg.; June 25.

Senate Special Aging Committee: will hold a hearing titled “Brain Injuries and Diseases of Aging;” 2:15 p.m., 562 Dirksen Bldg.; June 25.

Health Legislation Recently Introduced

H.R. 4875 (VETERANS’ HEALTH), to direct the secretary of veterans affairs to publish information on the provision of health care by the Department of Veterans Affairs, and for other purposes; BOUSTANY; to the Committee on Veterans’ Affairs, June 17.

H.R. 4879 (DRUGS), to amend the Federal Food, Drug, and Cosmetic Act to provide for expedited review of drugs and biological products to provide safer or more effective treatment for males or females, to amend the Public Health Service Act to enhance the consideration of sex differences in basic and clinical research, and for other purposes; COOPER; to the Committee on Energy and Commerce, June 17.

S. 2491 (MEDICARE), to protect Medicare under Title XVIII of the Social Security Act with respect to reconciliation involving changes to Medicare; PRYOR; read the first time, June 18.

S. 2492 (ACCESS), to amend the Internal Revenue Code of 1986 to increase access for the uninsured to high quality physician care; SCOTT; to the Committee on Finance, June 18.

H.R. 4887 (VETERANS’ HEALTH), to expand the research and education on and delivery of complementary and alternative medicine to veterans, and for other purposes; BROWNLEY of California; to the Committee on Veterans’ Affairs, June 18.

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