News & Analysis as of September 23, 2024

Cybersecurity › Health Information Technologies

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

Massachusetts Attorney General Announces Breach Resources for Consumers Impacted by Change Healthcare Breach

Foley Hoag LLP - Security, Privacy and the... on 7/16/2024

The Massachusetts Attorney General’s Office (AGO) issued an announcement last week to inform consumers who may have had their personal information breached in Change Healthcare’s cyberattack this past February. The AGO was...more

In Wake of Healthcare System Cyberattack, 22 State Attorneys General Call for Further Action of Data Privacy

Foley Hoag LLP - Security, Privacy and the... on 5/6/2024

On April 25, 2024, the attorneys general of 22 states issued a letter encouraging UnitedHealth Group and its subsidiary, Change Healthcare, to take additional steps to respond to a massively disruptive cyberattack. The broad,...more

HHS-OIG Releases Cybersecurity Toolkit

Foley Hoag LLP - Security, Privacy and the... on 3/27/2024

On March 26, 2024, the HHS Office of Inspector General (OIG) released a cybersecurity toolkit for HHS leaders to help them plan and deploy information systems in response to disasters and public health emergencies. The...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Skadden, Arps, Slate, Meagher & Flom LLP on 3/25/2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

HHS Updates Pixels and Trackers Guidance for HIPAA Regulated Entities

Foley & Lardner LLP on 3/21/2024

Pixels, cookies, and trackers continue to be front of mind for HIPAA regulated entities seeking clarity on their ability to advertise, market, and engage with existing and prospective patients. On March 18, 2024, the U.S....more

[Event] 28th Annual Compliance Institute - April 14th - 17th, Nashville, TN

Health Care Compliance Association (HCCA) on 12/5/2023

Get ready to be inspired with game-changing insights and industry connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas, learn...more

Cybersecurity Awareness Month: FDA Guidance on Cybersecurity in Medical Devices

Jackson Lewis P.C. on 10/23/2023

Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on...more

U.S. Senator requests information on ways to improve privacy protections of health data

Hogan Lovells on 9/12/2023

Adding to the growing trend of policymakers interested in regulating health and wellness data, last week U.S. Senator Bill Cassidy requested stakeholder feedback to help identify solutions to modernize HIPAA and ensure all...more

The Imperative of Cyber Preparedness: The Power of Tabletop Exercises

Bradley Arant Boult Cummings LLP on 8/15/2023

In an age where digital connectivity is rapidly advancing, cybersecurity has become an inescapable concern for organizations across industries. With cyber threats ranging from data breaches to ransomware attacks, it is...more

Cybersecurity: What Businesses Need to Know

Butler Snow LLP on 6/30/2023

Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

Health Apps Beware: FTC Clarifies Health Breach Notification Rule with Significant Proposed Changes

Akerman LLP - Health Law Rx on 6/9/2023

Direct-to-consumer health and wellness applications are forewarned: the Federal Trade Commission (FTC) is proposing changes to the Health Breach Notification Rule (HBNR), 16 C.F.R. part 318, that, if finalized, would cement...more

Focus on Electronic Health Information

Burr & Forman on 5/15/2023

There have been several recent governmental actions which highlight the balance between securing electronic patient information and the need for interoperability and appropriate exchange of such information. This article will...more

Washington Enacts First In the Nation Health Data Protection Law

UB Greensfelder LLP on 5/1/2023

By: Frances Floriano Goins and Michael Davis Hoenig About: Cybersecurity & Privacy May 1, 2023 – Last week, the Governor of Washington signed a package of legislation aimed at protecting the health care of women in response...more

Health Information Technology and Exchange Opportunities and Priorities for Older Adults

Manatt, Phelps & Phillips, LLP on 4/27/2023

Editor’s Note: Data exchange is crucial to coordinating care and services for older Californians, particularly those who have an array of health and social needs and require multidisciplinary teams to manage care and...more

Enforcement of U.S. Consumer Data Privacy Laws Part 1: Federal Agency Enforcement

Pierce Atwood LLP on 4/26/2023

A threshold consideration for businesses trying to understand the actors that enforce U.S. consumer privacy laws is an analysis of which laws apply to that business. This is because U.S. consumer privacy laws exist as a...more

FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions

Nelson Mullins Riley & Scarborough LLP on 4/18/2023

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more

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

Health Care Compliance Association (HCCA) on 1/17/2023

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

HHS Office for Civil Rights Posts HIPAA Security Rule Security Incident Procedures

Foley Hoag LLP - Security, Privacy and the... on 10/26/2022

Every October, in recognition of National Cybersecurity Awareness Month, the federal government and its partners work to educate stakeholders on cybersecurity awareness and how best to protect the privacy and security of...more

Supply Chain Vulnerability in the Healthcare Industry

Dunlap Bennett & Ludwig PLLC on 9/2/2022

The healthcare industry possesses invaluable data in the forms of patient health information, personal identifying information, and payment card information. The industry is a treasure trove of information to be exploited by...more

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on 8/17/2022

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

HIPAA Compliance & the Role of Enterprise Information Archiving

Hanzo on 6/28/2022

Most people have heard of the Health Insurance Portability and Accountability Act (HIPAA), so it’s not surprising that companies dealing with digital health information will have to be HIPAA compliant. To do so, any protected...more

Digital Health Trends to Watch in 2022

Morgan Lewis on 2/25/2022

In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

EyeMed Fined $600K for 2020 Data Breach

Rivkin Radler LLP on 2/1/2022

On January 24, New York Attorney General Letitia James announced a settlement with EyeMed Vision Care LLC based on shortcomings in the company’s data security procedures. The problems were discovered during the state’s...more

ECRI Names Cybersecurity Attacks as Top Health Technology Hazard for 2022

Robinson+Cole Data Privacy + Security Insider on 1/20/2022

ECRI has been publishing its annual report of health technology hazards for the past 15 years. According to ECRI’s Device Evaluation group, “the Top 10 Health Technology Hazards list identifies the potential sources of danger...more

FTC Policy Statement on Health Breach Notification Rule: A Conversation with Reece Hirsch

Morgan Lewis - Tech & Sourcing on 1/7/2022

As we start 2022, as part of our Spotlight series, we connect with Reece Hirsch, the co-head of Morgan Lewis’s privacy and cybersecurity practice, to discuss the recent policy statement issued by the US Federal Trade...more

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