Healthcare Law Today

FEBRUARY 1, 2022

Improves clinical trials by requiring the Food and Drug Administration (FDA) to issue guidance on the use of digital health technologies in clinical trials; decentralized clinical trials; and other innovative designs to support development of new drugs. Senators Murray and Burr expect the legislation to progress this year.

COVID-19 98

COVID-19 FDA Public Health Health Services Administration 98

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Healthcare IT Today

JANUARY 19, 2024

are expected to reach $6 trillion by 2027, cost containment and the push to increased decentralization of care will be a top healthcare priority in 2024. ” Madan Moudgal, Chief Executive Office at Sagility Technologies at Sagility In the landscape of generative AI, governance, privacy, and trust surface as pivotal concerns.

Hospitals 94

Hospitals Governance FDA Licensing 94

SQA

MAY 24, 2023

Having analyzed over 2000 responses received, the government will now take forward legislation to reform of the UK clinical trials regulatory framework that will: Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

FDA 52

FDA COVID-19 Compliance Governance 52

Hall Render

OCTOBER 27, 2023

Ransomware attacks against hospitals put patients’ lives at risk, researchers say States, FTC continue to target noncompetes: 3 updates The best hospital in each state, per Newsweek What to know about Stark law’s $9.2M with historic building purchase MICHIGAN Bronson raises capital campaign goal to $4.5M

US Department of Health and Human Services 40

US Department of Health and Human Services Nurses Nursing Homes Hospitals 40

Hall Render

NOVEMBER 17, 2023

Jill Biden will lead new initiative to boost federal government research into women’s health Joint Commission says acute, critical access hospitals must join safety network Lawsuit claims UnitedHealth AI wrongfully denies elderly extended care Most Rural U.S. Compensation is key Is spine surgery expansion next for ASCs?

Nursing Homes 40

Nursing Homes Nurses Hospitals Doctors 40