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Healthcare Pharmaceutical Industry Health Information Technologies

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #3

News Briefs - Physicians Responsible for Meeting CMS Information Blocking Rules - The Centers for Medicare & Medicaid Services and Office of the National Coordinator for Health Information Technology issued a final rule that...more

Fenwick & West Life Sciences Group

In 2024, the Digital Health Revolution Continues

Digital health is showing signs of life despite financial markets that seem determined to bring some of 2023’s volatility into the new year. Stocks are up and down, and bond yields are climbing. Inflation is proving stubborn,...more

McDermott Will & Emery

Investment Opportunities in 2024

McDermott Will & Emery on

In November, McDermott Will & Emery was pleased to host our annual European Health & Life Sciences Symposium in Paris. Welcoming a large crowd of healthcare professionals, investors and dealmakers for a programme of...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q3 2023

Bass, Berry & Sims PLC on

After steadying during Q2, it appears the overall volume of deals in the healthcare industry declined in Q3 compared with Q2, and year-to-date 2023 is still down from last year. A slumping economy has no doubt played a large...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | June 2023 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q2 2023

Bass, Berry & Sims PLC on

The healthcare M&A market appears to be steadying. Although deal activity through the year appears slightly below the high-water marks for the corresponding period of 2022, deal activity is generally up from the first quarter...more

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

Butler Snow LLP on

Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Nelson Mullins Riley & Scarborough LLP

FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Recommendations Regarding Electronic Systems, Records, and Signatures in Clinical Investigations

On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Fenwick & West Life Sciences Group

The Most-Funded Year Ever for Digital Health Startups – New Trends, Opportunities Emerge in Q3

At the end of Q3, aggregate funding raised by digital health startups in 2021 surpassed $20 billion. Although 2021 continues to be a record-breaking year for digital health startups, investors gently tapped the breaks in Q3....more

Arnall Golden Gregory LLP

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

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