News & Analysis as of

Healthcare Medical Devices Technology

Butler Snow LLP

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

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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

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

McDermott Will & Emery on

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

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

Jones Day

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

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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

White and Williams LLP

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

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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

Stinson LLP

FDA Eases Medical Evaluation and Recordkeeping Requirements for Hearing Aids

Stinson LLP on

On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and recordkeeping requirements (21 CFR §801.421(a) and (d)) prior to the...more

Robins Kaplan LLP

The Tech Industry’s Next Frontier?

Robins Kaplan LLP on

Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more

Stinson LLP

Off-Label Promotion —To Speak or Not To Speak?

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Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

Knobbe Martens

PilotFish Announces MedDevice Connection App

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Applied PilotFish Healthcare Integration, Inc. (APHII) recently announced a new application called HealthConnect. APHII is the healthcare division of PilotFish Technology, a provider of middleware solutions for the...more

Stinson LLP

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

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Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

Knobbe Martens

21st Century Cures Congressional Panel Unveils Medical Technology Proposals

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On January 27, 2015, members of the House Commerce and Energy Committee unveiled a set of legislative proposals aimed at speeding up the development of new medical technology. The 21st Century Cures panel, a bipartisan...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

McGuireWoods LLP

Medgadget Lists 2014's Best Medical Technologies

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Medgadget has come out with its list of the best medical technologies of 2014. They are as follows: - 1. Flexible Microelectronics...more

Foley & Lardner LLP

mHealth Technology – Development in an Uncertain Regulatory Climate

Foley & Lardner LLP on

The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more

Manatt, Phelps & Phillips, LLP

Health Update - September 2014

Engaging Patients While Addressing Their Privacy Concerns: The Experience of Project HealthDesign - Patients are using the Internet, personal health records (PHRs) and mobile applications or “apps” to collect and...more

Dorsey & Whitney LLP

Minnesota Federal District Court Explores Application of Corporate Practice of Medicine Doctrine to MRI Scans

Dorsey & Whitney LLP on

On March 25, 2014, in State Farm Mutual Automobile Insurance Company v. Mobile Diagnostic Imaging, Inc., the U.S. District Court for the District of Minnesota held that a corporation not owned or controlled by physicians does...more

Foley & Lardner LLP

Recommendations for NextGen Health IT Infrastructure

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Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute...more

Sheppard Mullin Richter & Hampton LLP

Thoughts on Regulatory Constraints of Business Models

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more

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