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The Health Sector Cybersecurity Coordination Center’s September 19 Threat Briefing on Healthcare Technology Security

As healthcare technology continues to evolve, so does the need for robust compliance strategies to safeguard patient information and ensure the integrity of medical devices. In a joint September 19, 2024 presentation, the...more

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

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

Recent Trends of State Attorneys General in Healthcare Regulation

State Attorneys General play a significant role in shaping health care policy across the country. While the national debates over health care policy in Congress and the federal government receive significant media attention,...more

FTC's Updated Health Data Breach Rule Covers Apps, Other New Tech

The FTC has updated its HBNR to clarify that the rule also restricts marketing practices involving personal health information. This update to the HBNR was announced on April 26, 2024, and follows several recent enforcement...more

Transforming Care Strategies -- Integration of AI in Healthcare: Summary of Legal/Regulatory Issues

I was pleased to take part in the “Transforming Care – Strategies for Integration of Artificial Intelligence in Healthcare” discussion, hosted by the New England Healthcare Executive Network at Foley Hoag on April 1. The...more

Change Healthcare Cyberattack: Actionable Next Steps for Impacted Entities

Change Healthcare Cyberattack - On February 21, 2024, Change Healthcare—a healthcare technology company owned by UnitedHealth Group—issued a statement that it had been impacted by a ransomware attack. According to Change...more

CISA Publishes Mitigation Guide to Combat Cyber Threats in the Healthcare and Public Health Sectors

If you need a little intellectual stimulation after hours of Thanksgiving turkey and football, the U.S. Cybersecurity and Infrastructure Security Agency (CISA) has just the thing — the new CISA Mitigation Guide for the...more

Your Password Can’t Possibly Be This Bad, Can It?

NordPass (the purveyor of a password manager) has assembled a list of the top 20 passwords in healthcare, based on usage by the world’s largest companies.  According to NordPass’s analysis, the “top” 20 passwords are: -...more

Massachusetts Extends Protections for Counseling Records of Survivors of Sexual Assault

Massachusetts Extends Protections for Counseling Records of Survivors of Sexual Assault - The Massachusetts Supreme Judicial Court has ruled in In the Matter of a Motion to Compel, SJC-13336 that the Superior Court could...more

HHS OCR/ONC Announce Latest Version of Security Risk Assessment Tool

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) have released version 3.4 of their Security Risk Assessment...more

Expiration of COVID-19 Public Health Emergency Means the Beginning of the End for HIPAA Privacy and Security Enforcement...

The Notifications of Enforcement Discretion issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act during the...more

The FTC Outlines What It Sees as “The HIdden Impacts of Pixel Tracking”

In a very comprehensive post from the Federal Trade Commission’s Office of Technology, the FTC takes what it calls “[a] deep dive into the technical side of FTC’s recent cases on digital health platforms, GoodRx &...more

Federal Public Health Emergency Extended to April 11, 2023

On January 11, 2023, the Department of Health and Human Services extended the COVID-19 public health emergency through at least April 11, 2023. This is the twelfth extension of the PHE since January 2020. HHS last renewed the...more

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

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

Key Considerations for Health App Developers from the FTC

If your company creates health-related apps, the Federal Trade Commission (FTC) has set out some key considerations: - Make accurate representations. Clearly explain how people’s information will be used and shared and then...more

National COVID-19 Preparedness Plan Summary

The White House has released a COVID-19 preparedness plan that assumes we will be living with the virus for the long term. The 96-page plan has four primary goals: (1) protect against and treat COVID-19, (2) prepare for...more

OSHA Issues Emergency Temporary Standard Rule for Healthcare Employers

On June 10, 2021, the U.S. Labor Department’s Occupational Safety and Health Administration (OSHA) released a nationwide emergency COVID-19 workplace safety rule, accompanied by a 916-page explanatory preamble. President...more

Fifth Circuit Addresses Scope of “Use” Under Federal Identity Theft Statute

You may have forgotten that there is a federal criminal identity theft statute, 18 U.S.C. § 1028A, which says: Whoever, during and in relation to any felony violation enumerated in subsection (c), knowingly transfers,...more

CISA Issues Ransomware Alert for Activity Targeting the Healthcare and Public Health Sectors

On October 28, 2020, a joint cybersecurity advisory was coauthored by the Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the Department of Health and Human Services...more

The CARES Act: Business and Subject Specific Alerts and Insights

On March 27, 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the third and by far the largest stimulus package passed by Congress to respond to the COVID-19 outbreak. As discussed...more

Enforcement of HIPAA Rules for Telehealth Relaxed Due to COVID-19 Public Health Emergency

On Friday, March 20, 2020, the Department of Health and Human Services Office for Civil Rights (“OCR”) announced it will “exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory...more

Surprise Bills Laws Enacted in California and New York

What Do They Mean for Providers? - Both California and New York have recently enacted so-called “Surprise Bills Laws” that require out-of-network providers to give notice to patients that a particular item or service...more

Massachusetts Legislation Proposes Cost Disclosures and Price Caps for Prescription Drugs

The Massachusetts Legislature is currently considering Senate Bill 1048, “An Act to Promote Transparency and Cost Control of Pharmaceutical Drug Prices.” The bill, sponsored by State Senator Mark Montigny, Vice Chair of the...more

New Rule Permits CMS to Revoke Medicare Billing Privileges for Providers/Suppliers with “Pattern or Practice” of Denied Claims

On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule titled “Requirements for Medicare Incentive Reward Program and Provider Enrollment” (“the Rule”). The Rule implemented several...more

FDA Releases Final Guidance on the Regulation of Mobile Medical Applications

On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more

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