News & Analysis as of

Data Collection Digital Health

Wyrick Robbins Yates & Ponton LLP

First Lawsuit Filed under Washington’s My Health My Data Act

After Washington adopted the My Health My Data Act (MHMDA) almost two years ago, we and others predicted that the law would lead to a wave of private lawsuits against companies operating in or adjacent to the health space....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

J.S. Held

Inside the Healthcare Industry: Understanding Emerging Data Privacy & Security Risks and Regulations

J.S. Held on

According to the Theft Resource Center and its 2022 data breach reports, data privacy and security threats are impacting all aspects of the healthcare industry – from providers to payers to medical device companies to...more

Foley & Lardner LLP

Decentralized Clinical Trials: Sponsor Responsibilities

Foley & Lardner LLP on

In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more

Sheppard Mullin Richter & Hampton LLP

Regulators Send Warning Letter to Hospitals and Telehealth Providers About Tracking Technology Use

The FTC and OCR at HHS are continuing to scrutinize the use of tracking technologies that may reveal information about a person’s health or health status. Both agencies recently sent a letter to a reported 130 hospitals and...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Bradley Arant Boult Cummings LLP

New Florida Law Will Ban Offshoring of Certain Patient Data

Effective July 1, 2023, a new Florida law will limit certain health care providers from storing patient information offshore. CS/CS/SB 264 (Chapter 2023-33, Laws of Florida), amends the Florida Electronic Health Records...more

Jones Day

Vital Signs Digital Health Law Update | Spring 2023

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Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more

Akerman LLP - Health Law Rx

The FTC Sends Another Warning to Digital Healthcare Platforms About Use of Tracking Pixels

The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 23, Number 2. Privacy Briefs: February 2023

Report on Patient Privacy Volume 23, no 2 (February 2023) DCH Health Systems, based in Tuscaloosa, Ala., said it fired an employee in December after a routine privacy audit revealed evidence that the worker had accessed some...more

Foley & Lardner LLP

Key Takeaways from the HLTH 2022 Conference

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With over 10,000 people in attendance, HLTH 2022 was inspiring and covered a wide range of subjects from health equity to the future of the digital health investment environment. Some sessions were laser-focused on current...more

Fox Rothschild LLP

Keep Your Health Data Secure. And Your App-Hosted Health Data Securer.

Fox Rothschild LLP on

California Attorney General Rob Bonta has issued statement about protecting health data in mobile apps in view of the upcoming SCOTUS decision in Dobbs. In the process, he also signaled continued enforcement....more

MoFo Life Sciences

FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

MoFo Life Sciences on

In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

King & Spalding

A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

King & Spalding on

With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more

Foley & Lardner LLP

FDA Addresses the Role of Digital Health Technology in Clinical Trials

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The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. DHT can take the form of hardware and...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more

Foley & Lardner LLP

Digital Health Apps Must Allow Users to Delete Accounts, Per New Apple App Store Rules

Foley & Lardner LLP on

The regulatory scrutiny on telemedicine and digital health companies continues to tighten, whether it is privacy warning shots, new direct-to-consumer (DTC) advertising limits, a wave of reimbursement audits, or multistate...more

Foley & Lardner LLP

CMS Proposes New Remote Therapeutic Monitoring Codes: What You Need to Know

Foley & Lardner LLP on

The Centers for Medicare & Medicaid Services (CMS) has proposed a new category of digital health services—Remote Therapeutic Monitoring (RTM)—to complement the existing suite of Remote Physiological Monitoring (RPM) codes...more

Foley & Lardner LLP

Telemedicine Companies Can Use Patent Law as a Strategic Advantage

Foley & Lardner LLP on

This is the first of a multi-part series on how telemedicine and digital health entrepreneurs can better avail themselves of patent and intellectual property strategies to gain a competitive advantage and increase the asset...more

Sheppard Mullin Richter & Hampton LLP

Recent FTC Settlement Serves as Reminder For Digital Health Developers

Many digital health app developers offering health and wellness solutions directly to consumers may find themselves in a space unregulated by the Health Insurance Portability and Accountability Act (“HIPAA”). While...more

Perkins Coie

DHHS Updates Resources for Mobile Health App Developers

Perkins Coie on

The COVID-19 pandemic and the resulting need for patient access to remote healthcare, as well as the development of contact-tracing apps, have spotlighted the importance of health-focused mobile applications (mHealth apps)....more

Womble Bond Dickinson

Wellness Wearables and Big Data

Womble Bond Dickinson on

Nearly half of Americans have tried wellness wearables or another digital health product. In a global pandemic, can we use the information tracked by wellness wearables to help prevent further spread and infection?...more

Jones Day

JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials

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Digital health technologies have brought a number of significant breakthroughs to clinical trial programs, including faster patient recruitment, more efficient data collection, and better tracking of biometric information....more

Troutman Pepper Locke

Exploring Digitization of Health and Medical Data and Records Part One

Troutman Pepper Locke on

The Digital Planning Podcast is designed to educate individuals about all things digital in connection with estate planning, business planning and estate administration. Your hosts, Jennifer Zegel, Ross Bruch and Justin...more

McDermott Will & Emery

Getting Cross-Industry Collaborations Right, Part 2: All About That Data

McDermott Will & Emery on

As discussed in the first post in this two-part series, new players from outside the traditional healthcare paradigm are joining forces with hospitals, health systems and other providers to drive unprecedented innovation....more

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