News & Analysis as of

Regulatory Requirements Health Technology

Smart & Biggar

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

Smart & Biggar on

On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more

Dentons

Ep. 58 – Addressing Potential Discrimination in Patient Care Decision Support Tools

Dentons on

Effective May 1, 2025, the Section 1557 regulations require covered healthcare providers to take reasonable steps by May 1, 2025, to identify and mitigate the risk of discrimination when they use AI and other emergency...more

Knobbe Martens

Boston Scientific Agrees to Acquire Sonivie Ltd. For up to $540 Million

Knobbe Martens on

Boston Scientific recently announced it entered into a definitive agreement to acquire SoniVie Ltd. According to the press release, SoniVie is a privately held medical device company that developed the TIVUS Intravascular...more

Ropes & Gray LLP

[Podcast] Women @ RopesTalk: Conversation with Jan Sbarbaro, Lyric

Ropes & Gray LLP on

On this episode of Women @ RopesTalk hosted by IP transactions and licensing partner Megan Baca, IP transactions partner Emily Karlberg returns for another engaging conversation, this time with Jan Sbarbaro, the chief legal &...more

Wiley Rein LLP

[Podcast] Pharmacy Benefit Segmentation: Emerging Models for Health Plans

Wiley Rein LLP on

In this episode of The Wiley Contracting Chronicles, hosts Jordan Ross and Brooke DeLoatch discuss the growing trend of pharmacy benefit segmentation among health plans. They outline three emerging models identified at Wiley:...more

Hogan Lovells

Early benefit assessment of medicinal products in Germany – first adaptions to AMNOG implementing the EU HTA Regulation

Hogan Lovells on

First adaption of German AMNOG to the EU HTA Regulation: With the German Federal Ministry of Health's recent adoption of the respective ordinance in Germany (AMNutzenV), the German legislator took a first step to integrate...more

Husch Blackwell LLP

Raising Capital in a Highly Regulated Market

Husch Blackwell LLP on

For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk...more

McDermott Will & Emery

Five Questions With a Health Lawyer: Stacey L. Callaghan

What is your favorite part about practicing healthcare law at McDermott? My favorite part about practicing healthcare law here at McDermott is the phenomenal team. There are thought leaders in every sub-specialty you can...more

Polsinelli

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

Polsinelli on

With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

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

Section 1557 Patient Care Decision Support Tools, Anti-Discrimination Compliance: 12 Things to Consider

McDermott Will & Emery on

In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more

McDermott Will & Emery

Pharma and MedTech Services Investment Summit 2024

McDermott Will & Emery on

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

Lathrop GPM

[Event] 2024 Health Law Seminar - July 24th, Minneapolis, MN

Lathrop GPM on

Join us for our annual Health Law Seminar taking place on Wednesday, July 24. The seminar will feature panels and presentations on the following topics: - Artificial Intelligence Use in Health Care - Recent Developments...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

Foley & Lardner LLP

“Let’s Talk Compliance”: Hot Topics in Compliance

Foley & Lardner LLP on

Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more

Health Care Compliance Association (HCCA)

[Event] 28th Annual Compliance Institute - April 14th - 17th, Nashville, TN

Get ready to be inspired with game-changing insights and industry connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas, learn...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 -...

Gardner Law on

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

Goodwin

In the Metaverse, Existing Healthcare Rules Apply

Goodwin on

Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations. The metaverse uses technologies such as...more

Latham & Watkins LLP

Healthcare Tech: What Legal Pitfalls Should Tech Companies Avoid As They Jump Into Healthcare?

Latham & Watkins LLP on

The US regulators have been particularly focused on new players in the health tech space and the novel regulatory issues their products present within the existing legal framework. While the market is ripe with opportunity...more

McDermott Will & Emery

[Virtual Event] 2021 J.P. Morgan Healthcare Conference - Hospital & Health Systems - January 13th, 12:00 pm - 2:00 pm EST

You won’t want to miss four days of exclusive, virtual events that bring together industry leaders, emerging standouts, innovators and investors from across the industry landscape at the largest healthcare investment...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

27 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide