Sec. 5. Establishment of the Office of Wireless Health Technology
524 words·~2 min read·
/bill/113/hr/2363/ih/section-5A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. ) is amended by adding at the end the following new section: There is established within the Office of the Commissioner an office to be known as the Office of Wireless Health Technology (referred to in this section as the Office ), which shall be headed by a director. The first Director of the Office shall be appointed by the Commissioner not later than 90 days after the date of enactment of this section.
The Director of the Office shall— through public meetings and other forms of communication with individuals and entities that design, produce, disseminate, or have a prevailing interest in wireless health technology, receive and analyze recommendations with respect to ways that existing regulations regarding wireless health technology might be made more reasonable and predictable, including ways that such regulations could be clarified and simplified; coordinate with Federal agencies, offices, institutes, and centers involved in the regulation of wireless health technology, including the Federal Communications Commission, the Office of the National Coordinator for Health Information Technology, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality, the National Institute of Standards and Technology, the Health Resources and Services Administration, and the National Institutes of Health, regarding activities of such agencies, offices, institutes, and centers that can be improved so as to make such regulation more robust, predictable, and easily understood and navigated by individuals and entities that design, produce, disseminate, or have a prevailing interest in wireless health technology; provide information to individuals and entities that design, produce, disseminate, or have a prevailing interest in wireless health technology on how to design, produce, or disseminate wireless health technology in accordance with existing law; and publish and make available on the public Internet Web site of the Food and Drug Administration in a searchable format an annual report that— explains how the Food and Drug Administration implemented regulations regarding wireless health technology during the prior year; analyzes the effectiveness of— such regulations; and other wireless health-related efforts by the Food and Drug Administration; and provides specific recommendations on how the Food and Drug Administration should improve its practices with regard to wireless health technology (in a manner that ensures consistency within the Food and Drug Administration regarding the application of its regulatory approach without compromising patient safety or privacy) in order to— remove barriers to innovations in such technology; and align such practices with the practices of other Federal agencies.
In carrying out the duties specified in subsection (c), the Director of the Office may consult with any working groups or commissions, including any working group or commission convened for a purpose related to the regulation of wireless health technology. For purposes of this section, the term wireless health technology has such meaning as specified by the Commissioner pursuant to regulation, but in no case shall include technology this is not regulated under the provisions of this Act (other than this section).
There is authorized to be appropriated to carry out this section $1,000,000 for each of fiscal years 2015 through 2019. .
Connectionstraces to 1
Traces to 1 document
U.S. Code
Citation graph
cites case law
Sec. 5
Establishment of the Office of Wireless Health Technology
Cites 1Cited by 0 across 0 sources