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BioWorld - Wednesday, April 22, 2026
Home » HHS

Articles Tagged with ''HHS''

Regulatory front for March 11, 2021

March 11, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIH touts new polygenic risk score methodology; HHS extends comment period for HIPAA NPRM.
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U.S. flag, stethoscope

MCIT program not seen as being at risk under Becerra at HHS

March 8, 2021
By Mark McCarty
The Biden administration imposed a regulatory freeze in January, which among other things affected the final rule for the Medicare Coverage of Innovative Technologies (MCIT) program. Despite the freeze, Cybil Roehrenbeck, a partner in the D.C. office of Hogan Lovells US LLP, told BioWorld that this program enjoys broad support in Washington, and thus should survive the new administration’s review of the program under Xavier Becerra, should he be appointed the Secretary of Health and Human Services.
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US flag, Department of Health and Human Services flags

U.S. Senate committee renders tie vote on Becerra to run HHS

March 3, 2021
By Mark McCarty
The U.S. Senate Finance Committee hearing for the appointment of Xavier Becerra as Secretary of Health and Human Services ended in a tie vote, which not unexpectedly ran along party lines. The nomination of Becerra was controversial on several fronts, but the outcome nonetheless sends the nomination to the Senate floor, where Vice President Kamala Harris may cast the deciding vote in what is likely to be a literal 50-50 deadlock.
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Xavier Becerra, HHS secretary nominee

Price transparency emphasized in Becerra’s first Senate hearing for HHS job

Feb. 23, 2021
By Mark McCarty
The first Senate hearing for the nomination of Xavier Becerra as Secretary of Health and Human Services included the predictable questions about his qualifications, given his position as attorney general for the state of California. However, the candidate repeatedly emphasized price transparency for both hospitals and drug manufacturers, the latter of which are still laboring under the perception that price gouging is a common practice.
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Regulatory front for Feb. 17, 2021

Feb. 17, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS commits more funds for testing, materials to fight pandemic; Medtronic announces recall of Valiant Navion; Florida man pleads guilty in DME fraud.
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Regulatory front for Feb. 12, 2021

Feb. 12, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA cites pivotal study failure for Lutonix 014; HHS adds to PREP Act immunity; Dermal fillers on tap at FDA advisory; GAO urges a pause in VA EHR deployment.
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Regulatory front for Feb. 11, 2021

Feb. 11, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA announces new health care supplier standard; Laggardly patient record response costs provider $75k; New med-tech resource platform now includes logistics; Spectrascience the subject of speculation, SEC action; HC nudging along with regulatory modernization plan.
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Regulatory front for Feb. 10, 2021

Feb. 10, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS posts request for information for Lyme diagnostics; NICE: Stak device backed by one 35-enrollee study.
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Packaging and kit components

Ellume signs $231M supply agreement with U.S. government for COVID-19 home tests

Feb. 2, 2021
By Tamra Sami
PERTH, Australia –Digital diagnostics company Ellume Ltd. announced a US$231.8 million agreement with the U.S. Department of Defense (DoD), in coordination with the Department of Health and Human Services (HHS), to accelerate domestic U.S. production of its COVID-19 home tests. The agreement includes funding to support the establishment of Ellume’s U.S.-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the U.S.
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Regulatory front for Jan. 28, 2021

Jan. 28, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.
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