News & Analysis as of

Medical Devices Licensing Rules

The Volkov Law Group

Commerce Department Promulgates New Rule Adopting Medical Device License Exception for EAR99 Exports to Russia, Belarus and...

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On April 29, 2024, the U.S. Department of Commerce officially published a final rule in the Federal Register that formally incorporates a medical device license exception into the Export Administration Regulations (“EAR”) for...more

Foley Hoag LLP

BIS Introduces New License Exception for Export of Medical Devices to Russia, Belarus, and Occupied Regions of Ukraine

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License Exception MED - On April 25, 2024, the Department of Commerce’s Bureau of Industry and Security (“BIS”) announced a final rule for a new license exception for “medical devices” under § 740.23 of the EAR (“License...more

Foley & Lardner LLP

Software as a Medical Device (SaMD): Health Care Regulatory Considerations

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Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more

Foley & Lardner LLP

Software as a Medical Device: Challenges Facing the Industry

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Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more

White and Williams LLP

Montana Significantly Revises Its Product Liability Laws

White and Williams LLP on

On May 4, 2023, Montana changed its product liability laws when the Governor signed SB 216, which was effective upon passage and applies to claims that accrue on or after May 4, 2023. Among the changes is the adoption of a...more

Morgan Lewis - Up & Atom

NRC Considering Expedited Review of Certain Part 20 Exemption Requests

US Nuclear Regulatory Commission (NRC) regulations at 10 CFR 20.1703(c)(5)(iii) and 10 CFR 20.1703(c)(6) require licensees to maintain a respiratory protection program that requires (1) a periodic—often annual—determination...more

Downs Rachlin Martin PLLC

Vermont Health Care Update 02-28-20 - An analysis from DRM's Health Law Team

House overrides minimum wage veto - On a vote of 100-49, the House voted to override Gov. Phil Scott’s veto of the minimum wage bill. The bill will raise the state’s minimum wage to $11.75 in 2021, and $12.55 in 2022, and...more

Downs Rachlin Martin PLLC

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

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

Akerman LLP - Health Law Rx

Florida Board of Pharmacy Initiates Work on International Export Pharmacy Permit Application and Rules

International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the...more

Hogan Lovells

Poland: impact of a no-deal Brexit scenario on biocidal products’ data changes, and the validity of parallel import licences for...

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The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques....more

Hogan Lovells

The South African pharmaceutical regulatory environment

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Our local pharmaceutical environment is highly regulated.The most important legislative provisions are found in the Medicines Act and the Pharmacy Act....more

Dorsey & Whitney LLP

HIMMS, Chronic Care Management, and the Top 5 Overlooked Items

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Harnessing existing digital health solutions to improve chronic care management was a prominent topic at HIMMS this year (amongst many others, including AI and cybersecurity, both of which we will cover in upcoming blog...more

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