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FDA’s Latest Twist on Digital Health Oversight Brings Big …

The FDA’s interpretation of the non-device CDS carve out as announced in the final guidance will, at a minimum, require software developers and device … See more

Actived: 3 days ago

URL: https://www.cooley.com/news/insight/2023/2023-01-03-fda-latest-twist-on-digital-health-oversight-brings-big-shift

FTC Revises Health Products Compliance Guidance

WebIn December 2022, the Federal Trade Commission released its Health Product Compliance Guidance, updating and replacing its 1998 industry advertising …

Category: Health Go Health

Life Sciences and Healthcare Regulatory

WebMazda Antia. Partner. San Diego. Vince Sampson. Special Counsel. Washington, DC. Top global healthcare, life sciences, fda & eu regulatory lawyers. Leading team counsels on …

Category: Health Go Health

Introducing Cooley’s Life Sciences & Healthcare …

WebPalo Alto – December 9, 2021 – Cooley has launched the Life Sciences & Healthcare Innovation Hub, a cross-practice, comprehensive resource that provides key …

Category: Health Go Health

Washington State’s My Health My Data Act FAQ, Part One …

WebThe law applies to data beyond traditional health data because the law defines “physical or mental health status” to include the following, without limitation (with …

Category: Health Go Health

Understanding Washington’s My Health My Data …

WebOn January 31, 2024, Cooley lawyers Brooke Fritz and Andrew Epstein led a virtual presentation on Washington state’s My Health My Data (MHMD) Act. Below are …

Category: Health Go Health

Washington State’s My Health My Data Act FAQ, Part Two …

WebIn Part Two of our FAQ series on Washington state’s My Health My Data (MHMD) Act, we answer questions related to some of the act’s substantive …

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Healthcare Lawyers // Cooley // Global Law Firm

WebSenior Counsel. Palo Alto. Mark Weeks. Partner. Palo Alto. Alexis Finkelberg Bortniker. Partner. San Diego. Top global healthcare lawyers. 40+ years representing …

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Proposed Rule on Laboratory-Developed Tests Takes …

WebFor the following categories of tests, FDA will continue to expect immediate compliance with the FDCA, Public Health Service Act and implementing regulations: …

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My Health My Data or All My Data

WebIn 2023, Washington’s legislature passed the My Health My Data Act (MHMD Act), ostensibly to protect “consumer health data” in response to the US Supreme …

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Washington Attorney General Publishes Updated FAQ for My …

WebWithout much fanfare, the Washington attorney general’s office updated its My Health My Data (MHMD) Act guidance FAQ in January 2024. Specifically, the …

Category: Health Go Health

Cooley’s Life Sciences and Healthcare Regulatory Group Continues

WebWashington, DC – November 13, 2023 – Cooley has further enhanced its life sciences regulatory and enforcement capabilities with the addition of Son Nguyen in the firm’s …

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Santa Clara County Requires Employers to Determine Worker

WebThe Santa Clara County Public Health Department landing page links to the new Order, as well as an executive summary, FAQs and other resources. The new Order …

Category: Health Go Health

One Medical Agrees to Acquire Iora Health in $2.1 Billion …

WebSan Francisco – June 9, 2021 – Cooley advised One Medical, a human-centered and technology-powered primary care organization, on its agreement to acquire Iora Health …

Category: Medical Go Health

CFPB, HHS and Treasury

WebJuly 13, 2023. On July 7, 2023, the Consumer Financial Protection Bureau (CFPB), US Department of Health and Human Services (HHS) and US Department of the Treasury …

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Virginia Enacts Permanent COVID-19 Employee Health and

WebOn January 13, the Virginia Department of Labor and Industry ’s Safety and Health Codes Board voted to enact a permanent workplace safety rule to protect …

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14th Annual Cooley Healthtech Conference

WebEvent summary. Join an exclusive gathering of top healthtech industry executives, investors, entrepreneurs and thought leaders for the 14th Annual Cooley …

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Cal/OSHA Enacts New COVID-19 Emergency Temporary Standards …

WebPlease see updated guidance in our alert from June 21. On June 3, 2021, the California Division of Occupational Safety and Health Standards Board adopted new …

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California Reinstates COVID-19 Supplemental Paid Sick Leave

WebOn February 9, 2022, California Gov. Gavin Newsom signed into law Senate Bill 114, which requires employers with 26 or more employees to provide supplemental paid sick leave …

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FDA Greenlights Florida’s Proposal for Importing Prescription …

WebOn Friday, January 5, 2024, the US Food and Drug Administration (FDA) authorized the Section 804 Importation Program (SIP) proposal of Florida’s Agency for Health Care …

Category: Food Go Health

2023 02 16 Bavarian Nordic Acquires Emergent BioSolutions Travel

WebLondon – February 16, 2023 – Bavarian Nordic, a vaccine company, has entered into a definitive agreement to acquire Emergent BioSolutions’ travel vaccines portfolio for up to …

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California Employers Facing New Employment Laws for 2024

WebThe applicable minimum wage is divided into four categories. For example, large employers with 10,000 or more full time employees are required to pay a minimum …

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