News & Analysis as of

Mobile Apps Digital Health Health Insurance Portability and Accountability Act (HIPAA)

K&L Gates LLP

Litigation Minute: Pixel Tools in the Health Care Arena (Pixel Tool Litigation Series: Part Four of Four)

K&L Gates LLP on

What You Need to Know in a Minute or Less - The use of pixel technologies on websites and mobile apps in the health care field has garnered considerable attention from regulators and the plaintiffs’ class action bar....more

McDermott Will & Emery

FTC Proposes Health Breach Notification Rule Amendments

McDermott Will & Emery on

The Federal Trade Commission (FTC), at its May 18, 2023, open Commission meeting, voted unanimously to issue a Notice of Proposed Rulemaking to amend the Health Breach Notification Rule (HBNR). The FTC’s proposed amendment...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

Perkins Coie

FTC Claims Sharing User Health Data With Advertising Platforms Is a “Security Breach”

Perkins Coie on

For the first time, the Federal Trade Commission has brought an enforcement action under its 2009 Health Breach Notification Rule (HBNR). The case was brought against a digital health company, GoodRx Holdings, Inc., for...more

Sheppard Mullin Richter & Hampton LLP

FTC and Other Regulators Continue to Signal Interest in Mobile Health Apps

The FTC is closing out 2022 with additional guidance for mobile health app developers signaling its continued interest in this industry. Since 2021, we have seen several steps from the agency demonstrating a focus on...more

K&L Gates LLP

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers – Part II: HIPAA (Continued) & Additional...

K&L Gates LLP on

In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...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

Wyrick Robbins Yates & Ponton LLP

The California Attorney General's Settlement with Glow: A Wake-Up Call for Consumer Health App Developers

Consumer-directed health apps are experiencing a boom thanks to COVID-19, as consumers seeking to avoid doctors’ office waiting rooms are increasingly relying on apps to measure and maintain their health.  That trend is...more

Morgan Lewis - Health Law Scan

Health Datapalooza - February 2020

Partner Reece Hirsch recently attended and spoke at the 2020 Health Datapalooza held in Washington, DC. This year, Health Datapalooza was co-located with the National Health Policy Conference, providing attendees with an...more

Burns & Levinson LLP

The Continuing Challenge of Cybersecurity Hygiene in Digital Health and Life Sciences

Burns & Levinson LLP on

A recent issue of MIT’s Technology Review magazine is titled, “Look how far precision medicine has come.“ At least part of the premise is that personalized medicine or precision medicine is not perceived as having made the...more

Wilson Sonsini Goodrich & Rosati

Digital Health: FDA Gives Nod to Multiple First-in-Class Devices

Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more

Troutman Pepper

AGs Weave Themselves Into Patchwork of Digital-Health Regs

Troutman Pepper on

There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

Polsinelli

Agencies Encourage New Privacy Regulations to Close the mHealth Black Hole and Keep Pace with Evolving Technologies

Polsinelli on

On July 19, 2016, the ONC submitted a report to Congress which suggests that health privacy regulations soon may be revised to catch up with the universe of mHealth technologies that now use and share personal health data....more

Polsinelli

OCR New Guidance Aims to Help Medical Mobile App Developers Predict when HIPAA Obligations Might Apply

Polsinelli on

Predicting whether the activities of a mobile health application developer trigger legal obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) presents some new challenges – not surprising...more

Faegre Drinker Biddle & Reath LLP

Get Your Questions Ready

A lot has changed since the HIPAA Privacy Rule was finalized in 2002 and the HIPAA Security Rule was finalized a year later in 2003. The iPhone had not been released (that happened in 2007), Apple had just released the...more

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