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- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more
In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more
On January 21 2025, the Council of the European Union (Council) announced its decision to adopt the Regulation of the European Parliament and of the Council on the European Health Data Space (EHDS). As we have previously...more
In early January, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rulemaking. The Proposed Rule would modify the Security Standards for the Protection of...more
On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more
On January 6, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published significant proposed amendments (proposed rule) to the Security Rule under the Health Insurance Portability and...more
Cyberattacks on healthcare organizations are on the rise, with the number of affected individuals nearly tripling between 2022 and 2024, according to data compiled by the Department of Health and Human Services Office for...more
‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more
Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more
The September Monthly Minute highlights the DOL’s extension of existing cybersecurity guidance to health and welfare plans and also addresses the new HIPAA reproductive health privacy rule....more
The Interim AI Measures is China's first specific, administrative regulation on the management of generative AI services. Laws/Regulations directly regulating AI (the “AI Regulations”) The Cyberspace Administration of China,...more
Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more
In response to the number of successful, large-scale ransomware attacks affecting healthcare organizations nearly tripling since 2018, the Department of Health and Human Services (HHS) has released guidance outlining its...more
As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the...more
A recently introduced bill in the Florida Legislature would provide businesses operating in Florida, including health care providers, with a legal defense to data breach lawsuits if they maintain robust cybersecurity measures...more
The Current Status of Privacy Laws Across the United States - Unlike the General Data Protection Regulation (GDPR) in the European Union (EU), the United States does not have a nationwide comprehensive data privacy law....more
New York has released proposed cybersecurity regulations for hospitals. The regulations, which were published in The State Register on Dec. 6 and will undergo a 60-day public comment period ending on Feb. 5, are designed to...more
On October 30, the U.S. government released its long-awaited, sweeping executive order (the AI EO or Order) on artificial intelligence (AI). The Order directs various U.S. government departments and agencies to evaluate AI...more
On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
For better or worse, generative artificial intelligence (AI) is already transforming the way we live and work. Within two months of its initial release to the public, ChatGPT reached 100 million monthly active users, making...more
The Federal Trade Commission (FTC) recently proposed changes to the Health Breach Notification Rule (Rule), enacted in 2009, to clarify that the Rule applies directly to an estimated 170,000 health and wellness mobile...more
In the span of two days, mobile device users learned of two data breaches that could compromise their personal data. In one, Experian (a credit reporting agency) reported that it was hacked, potentially putting 15 million...more