News & Analysis as of

Health Technology Regulatory Requirements Medical Devices

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

A&O Shearman on

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

McDermott Will & Emery

Pharma and MedTech Services Investment Summit 2024

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The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Gardner Law

Medtech Maturity: Assessing Regulatory Readiness

Gardner Law on

...It takes a lot to bring a medical product to market in the United States. You need impactful technology and proper resources to develop a product for years without the assurance it will ever see a patient. Understanding...more

McDermott Will & Emery

[Event] Pharma and MedTech Services Investment Summit 2024 - May 2nd, San Francisco, CA

McDermott Will & Emery on

YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Mintz - Health Care Viewpoints

Things to Consider When Determining the Regulatory Requirements for Software (Hint: It’s More Than the Device Classification)

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Foley & Lardner LLP

Key Contractual Considerations for Health AI and Hospital Collaborations

Foley & Lardner LLP on

If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create a transformative...more

Hogan Lovells

Digital health solutions in Germany: Detailed requirements for eligibility to reimbursement being fleshed out in draft legislation

Hogan Lovells on

Introduction In November 2019, the parliament passed a new law which will provide reimbursement for digital healthcare provision for the around 70 million publicly insured patients in Germany (Digital Health Service...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - October 2019

In this month's edition of our Privacy & Cybersecurity Update, we examine the California attorney general's draft regulations on the California Consumer Privacy Act, the CJEU's clarified rulings on the use of cookies, the...more

Hogan Lovells

The European Parliament adopted a report on the Commission Proposal for a Regulation on Health Technology Assessment

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On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA)....more

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