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Software Department of Health and Human Services (HHS)

Ankura

Updates to the Translation and Accessibility Standards for Required Materials and Content in the Medicare 2024 Final Rule

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Medicare Advantage Organizations and Part D sponsors have a responsibility to ensure they offer and provide their members and potential enrollees with content and materials in alternate languages or accessible formats for...more

Balch & Bingham LLP

Eight Categories Summarizing the Directives of Biden’s Executive Order on Artificial Intelligence

Balch & Bingham LLP on

On October 30, 2023, President Biden issued an “Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence” (“EO”) that issues a multitude of directives across a wide swath of federal agencies and departments,...more

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more

Jones Day

Vital Signs Digital Health Law Update | Summer 2023

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more

Health Care Compliance Association (HCCA)

Privacy Briefs: June 2023

Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Robinson+Cole Data Privacy + Security Insider

MedEvolve OCR Settlement for $350,000 due to Alleged Failures to Protect Data

On May 17, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced a settlement with MedEvolve, Inc. for $350,000. MedEvolve provides practice and revenue cycle management and practice...more

J.S. Held

Litigation Surge From the Use of Tracking Technology & the Sharing of Healthcare and Personal Data

J.S. Held on

Introduction: Tracking Software in the Healthcare Industry - Privacy-related concerns have become increasingly prominent in recent years, especially with the widespread use of third-party tracking tools such as tracking...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

CISA Announces New Binding Operational Directive to Manage Federal Civilian Agency Threats

Takeaway: The latest directive from CISA will enhance federal agencies’ ability to identify vulnerabilities in their networks to prevent and respond to cybersecurity incidents....more

Wiley Rein LLP

Cabinet Agencies Publish U.S. Critical Supply Chain Reports

Wiley Rein LLP on

On February 24, 2022, seven cabinet agencies published reports in response to President Biden’s Executive Order (EO) 14017 with assessments of and recommendations for strengthening certain critical U.S. supply chains....more

McDermott Will & Emery

Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on

On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more

Baker Donelson

Regulatory Sprint: HHS Proposes Expansion of Protections for EHR and Cybersecurity Donations

Baker Donelson on

In furtherance of its goals of expanding the adoption of electronic health records (EHR) and improving security through the use of cybersecurity technology, the Department of Health and Human Services (HHS) has proposed...more

Mintz - Health Care Viewpoints

A Tale of Two False Claims Act Settlements Involving EHR Vendors

Last week the Department of Justice (DOJ) announced a $57 million settlement with electronic health record (EHR) software vendor Greenway Health LLC (Greenway). According to DOJ, Greenway violated the False Claims Act (FCA)...more

Jones Day

"Meaningfully Useful" Risk Mitigation Strategies for Providers Following the eClinicalWorks Settlement

Jones Day on

The Health Information Technology for Economic and Clinical Health Act ("HITECH Act") established financial incentives under Medicare and Medicaid for eligible health care providers that adopt, implement, and demonstrate use...more

McDermott Will & Emery

Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

The US Department of Health and Human Services (HHS) has recently issued guidance under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and...more

Sheppard Mullin Richter & Hampton LLP

HHS releases new software for updating (but not replacing) HIPAA security risk assessment toolkits

Last week, the Department of Health and Human Services (HHS) released a new, free, downloadable tool to assist small and medium-size health care provider offices to conduct security risk assessments (SRA)....more

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