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Mobile Apps Digital Health

MoFo Life Sciences

Digitalization Of German Healthcare System To Receive Legislative Boost In 2024

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It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At...more

Arnall Golden Gregory LLP

FDA Issues New Draft Guidance on Regulatory Considerations for Prescription Drug Use-Related Software

New technologies continue to emerge that improve care for patients taking prescription medications. On September 18, 2023, five years after the Food and Drug Administration sought initial public comment, the agency issued its...more

K&L Gates LLP

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

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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

Arnall Golden Gregory LLP

Comment Deadline Approaching: Health Breach Notification Rule

Summary - On May 18, 2023, the Federal Trade Commission (“FTC”) announced a Notice of Proposed Rulemaking (the “Proposed Rule”), which both clarifies the scope of the Health Breach Notification Rule (“HBN Rule”) to include...more

McDermott Will & Emery

FTC Proposes Health Breach Notification Rule Amendments

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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”

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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

Fox Rothschild LLP

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

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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

K&L Gates LLP

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

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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

Foley & Lardner LLP

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

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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

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

Jackson Lewis P.C.

More Movement towards Digital COVID Vaccination Records

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A key tech initiative as COVID-19 vaccinations begin rolling out are digital health passports. One example is being developed by a group of large tech companies along with the Mayo Clinic as part of the Vaccination Credential...more

Perkins Coie

DHHS Updates Resources for Mobile Health App Developers

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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

FDA Regulation of COVID-19 Apps, Digital Therapeutics, and Other Digital Health Technologies

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With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19...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

Nossaman LLP

FDA Policy for Mobile Medical Applications

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The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more

McDermott Will & Emery

[Event] Munich Life Sciences Bootcamp For In-House Counsel - November 21st, Munich, Germany

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McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more

Patterson Belknap Webb & Tyler LLP

FDA Issues Updated Guidance on Medical Apps Oversight

Last month, the Food & Drug Administration (FDA) issued a long-awaited revision to its Policy for Device Software Functions and Mobile Medical Applications Medical App - Guidance for Industry and Food and Drug Administration...more

Foley & Lardner LLP

OIG Greenlights Digital Health Program Offering Free Smartphones to Patients

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Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare...more

Holland & Knight LLP

OIG Approves Pharmaceutical Manufacturer’s Loaning of Smartphones to Support Digital Medicine (DM)

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On Jan. 29, 2019, the Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and...more

Burns & Levinson LLP

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

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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

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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

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