POLICY BRIEFINGS


FDA Proposes Update on Medical Device Classification


The Food and Drug Administration (FDA) issued a proposed rule, pursuant to the FDA Safety and Innovation Act (FDASIA) that would update the current classification of medical devices, including mobile health devices. Comments are due by June 23.


HHS Releases HIPAA Tool to Assess Security Risk


The HHS Office of the National Coordinator for Health Information Technology and the Office for Civil Rights announced the availability of a downloadable app which small and medium-size medical practices can use to aid them in all aspects of assessing information security risk and to help provide the documentation needed under the Health Insurance Portability and Accountability Act (HIPAA) for the prevention of any breach of protected health information.


Upcoming Health-Related Hearings and Markups


House Energy and Commerce Subcommittee on Health: will hold a hearing titled “Examining Concerns Regarding FDA’s Proposed Changes to Generic Drug Labeling;” 2:00 p.m., 2123 Rayburn Bldg.; April 1.

House Committee on Veterans’ Affairs Subcommittee on Oversight and Investigations: will hold a hearing titled “VA & Human Tissue: Poor Practice and Lack of Tracking Endangers Veterans;” 10:00 a.m., 334 Cannon Bldg.; April 2.

Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies: will hold a hearing on proposed FY 2015 appropriations for the National Institutes of Health; 10:00 a.m., 192 Dirksen Bldg.; April 2.

House Energy and Commerce Health Subcommittee: will hold a hearing on the Helping Families in Mental Health Crisis Act of 2013. 10:30 a.m., 2322 Rayburn; April 3.

House Veterans’ Affairs Health Subcommittee: will mark up pending legislation; 9:00 a.m., 334 Cannon Bldg.; April 4.


Health Legislation Recently Introduced


H.R. 4282 (GRADUATE MEDICAL EDUCATION), to amend the Public Health Service Act to authorize grants for graduate medical education partnerships in states with a low ratio of medical residents relative to the general population; CASTOR of Florida; to the Committee on Energy and Commerce, March 21.

S. 2150 (DRUG RESEARCH), to advance the public health by encouraging independent innovators to pursue drug repurposing research and develop new treatments and cures by providing appropriate intellectual property protections for those innovations, and for other purposes; BLUMENTHAL; to the Committee on the Judiciary, March 24.

H.R.4288 (OPIOID OVERDOSE DRUGS), to provide certain protections from civil liability with respect to the emergency administration of opioid overdose drugs; NEAL; to the Committee on the Judiciary, March 24.
S. 2154 (CHILDREN’S HEALTH), to amend the Public Health Service Act to reauthorize the Emergency Medical Services for Children Program; CASEY; to the Committee on Health, Education, Labor and Pensions, March 25.

H.R.4287 (DRUG RESEARCH), to advance the public health by encouraging independent innovators to pursue drug repurposing research and develop new treatments and cures by providing appropriate intellectual property protections for those innovations, and for other purposes; CASTOR of Texas; to the Committee on the Judiciary, March 24.



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