News & Analysis as of

Mobile Apps Electronic Medical Records

BakerHostetler

FTC Vastly Expands Reach of the Health Breach Notification Rule

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On April 26, the Federal Trade Commission (FTC) announced its final rule (Final Rule) making changes to the Health Breach Notification Rule (HBNR)....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

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 23, Number 1. Privacy Briefs: January 2023

Report on Patient Privacy Volume 23, no 1 (January 2023) The Centers for Medicare & Medicaid Services (CMS) said a data breach at a Medicare subcontractor impacted the personally identifiable information and protected...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

Stinson LLP

Health App Vendors Be Warned: You Could Be Subject to FTC's Health Breach Notification Rule

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The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...more

Lippes Mathias LLP

New ‘Information Blocking’ Compliance Obligations Take Effect April 5, 2021

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The 21st Century Cures Act (Act) and a recently adopted final rule by the Office of the National Coordinator for Health Information Technology (ONC) in the U.S. Department of Health and Human Services will now prohibit...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

Rivkin Radler LLP

OCR Updates Mobile Health App Resources

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The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently unveiled a new website with updated guidance and resources for mobile health app developers regarding the HIPAA Privacy, Security, and...more

Robinson+Cole Data Privacy + Security Insider

Changing the Conversation About Sharing and Using Health Information

Some app developers know more about our health than our doctors do. Take, for instance, FitBit, which is attached to our wrist and measuring in real time our temperature, our heart rate, our steps and whether we have had...more

Ballard Spahr LLP

The Office for Civil Rights Speaks: HIPAA Liabilities Contained (Except When They Aren’t)

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After a quiet winter, the Department of Health and Human Services’ Office for Civil Rights (OCR) revived with the spring, issuing a set of frequently asked questions and two recent announcements. ...more

Foley Hoag LLP - Security, Privacy and the...

MaHIMA Webinar: "Alexa, What Medication Am I Taking?" (Presentation)

"Open the pod door, HAL" • Commercial voice-activated intelligent personal assistants from Amazon, Apple, Google, and Microsoft, among others, are growing in popularity. • A report from NPR and Edison Research states...more

McDermott Will & Emery

Recycle, Recycle, Recycle: Key Considerations for Research, Medical Education, and Other Secondary Uses of Data

The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with potential to provide valuable insights into disease and wellness and help...more

Mintz - Health Care Viewpoints

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...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

Polsinelli

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

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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

Manatt, Phelps & Phillips, LLP

Manatt Digital Media - October 2015

In this newsletter, we highlight some of the ways digital technologies are transforming healthcare and the opportunities and challenges they present to individuals and businesses. We also introduce you to our team at Manatt...more

Davis Wright Tremaine LLP

[Webinar] Mobile Device Management for Health Care Organizations and Vendors - Sept. 10th, 10:00am PDT

In this webinar, we will demystify the HIPAA Security Rule and how to apply the administrative, physical, and technical safeguards in a mobile environment. We will discuss key takeaways from the recently released NIST Draft...more

Foley & Lardner LLP

Is My Telehealth App Subject to HIPAA?

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Many telehealth and mHealth app developers are concerned about whether or not their app is a medical device under FDA regulations (and rightfully so), they often pay less attention to the Health Insurance Portability and...more

BakerHostetler

Use of File-Sharing Service Leads To $218,400 Fine For HIPAA Violations

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Internet-based file-sharing services such as Dropbox and Google Drive can be easy and convenient to use, whether via the touch of an app on a mobile device or by opening a browser on a PC. Healthcare professionals are often...more

Goodwin

FDA Issues Final Guidance on Mobile Medical Applications

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Last week, the FDA issued guidance on its approach to regulating mobile apps. FDA intends to regulate only those mobile apps that meet the agency’s definition of “device” and are considered higher risk in that they could...more

Fenwick & West Life Sciences Group

Big Data Could Save Healthcare System $300+ Billion Annually

According to a recent report released by Rock Health, Big Data has the potential to save the healthcare system more than $300 billion per year by improving poorly coordinated care, reducing fraud and abuse, and improving...more

Fenwick & West Life Sciences Group

Venture Investment in Digital Health Effectively Doubles in H1 2012

Venture investment in healthcare convergence technologies soared in the first half of 2012. According to a recent report from Burrill & Co, digital health, into which they group healthcare IT, mobile health and wireless...more

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