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Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Dickinson Wright

Part 3: Key Takeaways from Claim Examples in the 2024 AI Patent Eligibility Guidance

Dickinson Wright on

This is the third post in a 3-part series. Below, we describe Example 49 which focuses on using AI to assist with a medical treatment....more

Akin Gump Strauss Hauer & Feld LLP

Just Prior to Leadership Change, FDA Announces Public Workshops to Advance Dialogues on HCT Product Development and Optimizing...

Akin Gump Strauss Hauer & Feld LLP on

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more

Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

Epstein Becker & Green on

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act - Part Ten: Operational Realities and Next Steps

Quarles & Brady LLP on

This is Part Ten in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act : Part Nine: Enforcement and Private Right of Action

Quarles & Brady LLP on

This is Part Nine in a series of legal updates on the Washington My Health My Data (“WMHMDA”) where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act - Part Two: Consumers Covered by WMHMDA

Quarles & Brady LLP on

This is Part Two in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”) where Quarles is doing a deep dive into the various factors and intricacies of the Act that are shaping up to create a sea of...more

McDermott Will & Schulte

Health Data in the EU and UK – Regulatory Trends and Developments

McDermott Will & Schulte on

In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more

Butler Snow LLP

International Privacy Laws and Clinical Trials

Butler Snow LLP on

Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more

Sheppard Mullin Richter & Hampton LLP

Notes from the 2019 Health Evolution Summit: Promoting Quality Healthcare and a Quality Healthcare Experience

Sheppard Mullin Richter & Hampton LLP on

Laguna Niguel, California. Another wild year in healthcare is upon us and another insightful and inspiring week of discussions at the 2019 Health Evolution Summit (HES) has just wrapped up in California. HES, which many refer...more

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