News & Analysis as of

Medical Devices Technology

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 1, January 2024

The Current Status of Privacy Laws Across the United States - Unlike the General Data Protection Regulation (GDPR) in the European Union (EU), the United States does not have a nationwide comprehensive data privacy law....more

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas...more

Foley & Lardner LLP

Protecting Innovations in SaMD & Biomedical Applications

Foley & Lardner LLP on

With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more

Perkins Coie

Washington State’s New My Health My Data Act Will Likely Result in Insurance Coverage Disputes

Perkins Coie on

Washington state recently passed the My Health My Data Act (the Act), which will almost certainly lead to an explosion of consumer lawsuits and follow-on insurance coverage disputes. The measure is intended to protect...more

Faegre Drinker Biddle & Reath LLP

Why 3D Printing Doesn’t Have to be a Pandora’s Box for IP Rights

Personal 3D printing has seen leaps in advancement in recent years, allowing users to render increasingly sophisticated creations from the comfort of their own home. These creations can include anything from gaming miniatures...more

Foley Hoag LLP

FDA Releases Guidance on Submissions for AI/ML-Enabled Devices

Foley Hoag LLP on

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more

Fish & Richardson

Webinar | Protecting Your Femtech IP

Fish & Richardson on

Femtech is a growing industry that develops solutions to women’s healthcare issues that historically have been underfunded, under researched, and misunderstood. It focuses primarily on conditions that present differently in...more

MoFo Life Sciences

The Importance Of Patents For ML-Based Medical Device Inventions

MoFo Life Sciences on

The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies....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

Latham & Watkins LLP

UK’s MHRA Publishes Response to Consultation on Future Medical Devices Regulation

Latham & Watkins LLP on

The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more

Faegre Drinker Biddle & Reath LLP

Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care...more

MoFo Life Sciences

Five Key Takeaways From FDA’s Transparency Of AI/Ml-Enabled Medical Devices Virtual Workshop

MoFo Life Sciences on

On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the...more

Rivkin Radler LLP

Smart Speakers Can Monitor Heartbeats

Rivkin Radler LLP on

Researchers from the University of Washington have developed a system that uses smart speakers and machine learning algorithms to monitor heartbeats without the need for physical contact. The system was described in a study...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

Porter Hedges LLP

Patent Litigation Considerations For The Internet Of Medical Things (IoMT) COVID-19 Boom

Porter Hedges LLP on

The COVID-19 pandemic has been a catalyst for medical technology innovation, especially the Internet of Medical Things (IoMT). IoMT generally refers to the use of network and cloud technologies to connect medical equipment...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

McDermott Will & Emery

US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence

McDermott Will & Emery on

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more

McDermott Will & Emery

US Office of Management and Budget Issues a Memorandum Calling for Agency Plans From Federal Government Agencies

McDermott Will & Emery on

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...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

Hogan Lovells

[Webinar] Health Care and the Internet of Things: New Regulatory Developments - July 25th, 2:00pm EDT

Hogan Lovells on

Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...more

Hogan Lovells

The European Commission releases an updated Borderline Manual for medical devices

Hogan Lovells on

The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in...more

White and Williams LLP

“Magic Arms”: The Future of 3D Printing and Its Impact on Healthcare

White and Williams LLP on

In the past, doctors and researchers were limited in the types of individualized devices they could create for their patients; now, 3D printing presents the possibility of creating almost any device, limited only by their...more

Pillsbury - Internet & Social Media Law Blog

News of Note for the Internet-Minded – “Dark Patterns,” DNA Mining and Angsty AI Poetry

Recent technology news provides its usual mix of hope, distractions and hand-wringing-worthy developments. (Granted, one of these items is not so much “news” as an ever-present truth about TOS.)...more

Hogan Lovells

"Make in India" Initiative Extends to Medical Devices - India's New Medical Device Rules Are Now in Effect

Hogan Lovells on

In January 2017, India's Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017 (MDR 2017 or the Act), which took effect on January 1, 2018. Upon implementation, this regulation replaced...more

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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