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Cybersecurity › Pharmaceutical Industry › Digital Health

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +
Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now.   less -
Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - June 2024 #1

Arnall Golden Gregory LLP on

News Briefs - Hospital Lobbies Join Attempt to Delay Noncompete Ban -Hospital lobbies have signed on to a multisector letter of 230 industry associations and chambers of commerce urging the Federal Trade Commission to bump...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Skadden, Arps, Slate, Meagher & Flom LLP on

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Health Care Compliance Association (HCCA) on

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

Morgan Lewis

Digital Health Trends to Watch in 2022

Morgan Lewis on

In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2021

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Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

Wiley Rein LLP

Full Speed Ahead – FDA’s Digital Health Center of Excellence to Host Listening Sessions

Wiley Rein LLP on

On September 22, 2020, the U.S. Food and Drug Administration (FDA) announced the establishment of the Digital Health Center of Excellence (DHCE) within FDA’s Center for Devices and Radiological Health (CDRH). Bakul Patel will...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Sheppard Mullin Richter & Hampton LLP

FDA Year in Review: A Shifting Regulatory Landscape

Sheppard Mullin Richter & Hampton LLP on

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...more

K&L Gates LLP

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

K&L Gates LLP on

As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

Mintz - Health Care Viewpoints on

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Value-based purchasing

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

Mintz - Health Care Viewpoints

Medical Products & FDA: What to Watch for in 2019

Mintz - Health Care Viewpoints on

Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

Hogan Lovells on

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

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