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Technology Medical Devices Digital Health

McDermott+

Back for seconds: digital health policies in the CY 2026 PFS proposed rule

McDermott+ on

It’s been more than two weeks since the release of the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule. We’ve had a chance to digest our initial helping and now we’re ready for seconds. We thought we would see...more

MoFo Life Sciences

Key Developments in MedTech M&A: Momentum Despite Macroeconomic Uncertainty

MoFo Life Sciences on

2024 was a challenging year for M&A activity in the medical technology (“MedTech”) industry. Although some sectors experienced a rebound in deal volume, MedTech dealmakers were disproportionately affected by a difficult...more

Barnea Jaffa Lande & Co.

Femtech in Israel: The Challenges, Opportunities, and Legal Considerations Every Company Needs to Know

The field of women’s health technology (FemTech) is rapidly evolving, and Israel is considered one of the global leaders, ranking fourth worldwide in the number of FemTech companies. Additionally, Israel ranks second in...more

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

Butler Snow LLP on

Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

Mintz - Health Care Viewpoints

FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies

The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

Nilan Johnson Lewis PA

Anti-Kickback Statute and Stark Law Regulations: Final Rules Issued

Nilan Johnson Lewis PA on

On November 20, 2020, the Department of Health and Human Services (HHS) published two final rules that aim to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system to...more

Jones Day

Patenting Digital Health Innovations Incorporating AI in View of USPTO's Recent Subject Matter Eligibility Guidance

Jones Day on

Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Can Digital Healthcare Innovation Be Patented? Eligibility of Digital Healthcare Technologies Under the New USPTO Eligibility...

Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more

Fenwick & West Life Sciences Group

Digital Health Investors Catch Their Breath in November

Digital health investors seem to have taken a step back to catch their breath in November after 10 months of record-breaking activity. There were only 6 investments in November of $10 million or more and only one for more...more

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