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Medical Devices › Patient Access

Epstein Becker & Green

A New Prescription for Access: The Department of Justice Celebrates Anniversary of the ADA by Finally Issuing Title II Medical...

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To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for...more

Burr & Forman

Proposed Revisions to Title II of the ADA Impacting Healthcare Facilities

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The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more

Nelson Mullins Riley & Scarborough LLP

OIG Issues Unfavorable Opinion About Bundling Free Items with Reimbursable Services

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On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 66

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Competition - European Commission comments on the future of competition policy - On 29 October 2021, Executive Vice-President and Competition Commissioner Margrethe Vestager provided remarks on the future of competition...more

Hogan Lovells

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

Nossaman LLP

Health Care Providers’ Crisis Care Guidelines in Light of Recent OCR and CDPH Guidance

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Faced with an ongoing public health emergency that threatens to overload healthcare systems, many states, including California, have developed or revisited their crisis care guidelines to address a potential COVID-19 patient...more

Akerman LLP

Summary of Healthcare Provisions in CARES Act

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The United States is experiencing an unprecedented shutdown affecting almost all aspects of life due to the current pandemic. To speed relief to the economy, on March 27, 2020, Congress enacted the Coronavirus Aid, Relief,...more

Downs Rachlin Martin PLLC

Vermont Health Care Update 02-17-2020 - An analysis from DRM's Health Law Team

Downs Rachlin Martin PLLC on

Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more

Faegre Drinker Biddle & Reath LLP

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...

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The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more

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