News & Analysis as of

Information Technology Healthcare

Burr & Forman

Healthcare Provider Disincentives for Information Blocking

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On June 31, 2024, the Department of Health and Human Services (“HHS”) published a final rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century Cures...more

McDermott Will & Emery

Key Takeaways | Clinical Research Technology (ClinTech)

McDermott Will & Emery on

During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases...more

Ballard Spahr LLP

2024 HIPAA Developments

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Over the course of the past few months, the Office of Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC), both of which are divisions of the U.S. Department of Health and...more

Dentons

Ep. 19 - What to Do When Your Business Associate Suffers a Ransomware Attack

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The healthcare industry remains a popular target for ransomware attacks. If you haven’t been impacted by a ransomware attack, it’s likely only a matter of time before someone you do business with or buy services from is...more

Health Care Compliance Association (HCCA)

Privacy Briefs: May 2024

Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more

Burr & Forman

FDA Releases New Draft Guidance Regarding Clinical Trial Data Monitoring Committees

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The U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a data monitoring committee (DMC) in clinical trials. Originally...more

Health Care Compliance Association (HCCA)

Privacy Briefs: April 2024

The Cybersecurity and Infrastructure Agency (CISA) is seeking comment on a proposed rule to implement reporting requirements for critical infrastructure entities, including health care entities, on cyberattacks and ransomware...more

Wyrick Robbins Yates & Ponton LLP

Sense and Sensitivity: Latest FTC Enforcement Actions Continue Focus on Sensitive Health Data

We’ve talked before about the FTC’s focus on consumer health privacy. In cases against BetterHelp and GoodRx, a blog post announcing rules it intends to enforce in the space, and a report summarizing its recent privacy and...more

Robinson & Cole LLP

Health Law Diagnosis - April 2024

Robinson & Cole LLP on

Additional States Implement Notice Requirements for Healthcare Transactions - In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions....more

McDermott Will & Emery

Special Report: Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework

McDermott Will & Emery on

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more

Epstein Becker & Green

ONC’s “Information Blocking Enhancements” Under the HTI-1 Rule Are in Effect

On Monday, March 11, 2024, the Office of the National Coordinator for Health Information Technology’s (ONC) Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information...more

Paul Hastings LLP

CISA Proposes Sweeping Cybersecurity Incident Reporting for U.S. Companies

Paul Hastings LLP on

On March 27, 2024, the Cybersecurity & Infrastructure Security Agency (“CISA”) released proposed regulations requiring expansive new cybersecurity incident and ransomware payment reporting across sixteen “critical...more

Akin Gump Strauss Hauer & Feld LLP

Geneva Insights - April 2024

The World Trade Organization (WTO) Committee of Participants on the Expansion of Trade in Information Technology Products (ITA Committee) meets on April 11. The committee holds regular meetings twice a year to review...more

Wiley Rein LLP

CISA’s Proposed Cyber Incident Reporting Requirements Would Hit a Range of Industries and Sectors

Wiley Rein LLP on

The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is publishing a proposed rule (Proposal or NPRM) that will require broad segments of industry to meet onerous and quick...more

Spilman Thomas & Battle, PLLC

HHS Cybersecurity Performance Goals and the Healthcare Industry

The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare industry is such a ripe hunting ground for cybercriminals, the...more

Shutts & Bowen LLP

New Guidelines Anticipated Following HHS’s Health Cybersecurity Concept Paper

Shutts & Bowen LLP on

Updates to the Health Insurance Portability and Accountability Act Security Rule (“HIPAA Security Rule”) are planned for Spring 2024. New guidance from The Department of Health and Human Services (“HHS”) via a recently...more

McDermott+

McDermottPlus Check-Up: February 9, 2024

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House Passes Legislation to Prohibit Use of QALYs in All Federal Health Programs. The House passed H.R. 485, the Protecting Health Care for All Patients Act of 2023, a bill designed to prohibit the use of QALYs and similar...more

Health Care Compliance Association (HCCA)

Privacy Briefs: February 2024

The American Hospital Association (AHA) has warned that information technology (IT) help desks are being targeted in a social engineering scheme that uses the stolen identity of revenue cycle employees or employees in other...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

Fenwick & West LLP on

On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

Snell & Wilmer

HHS Establishes Certification Requirements for Artificial Intelligence and Machine Learning Software Developers

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As the impact of artificial intelligence on various sectors of the U.S. economy grew in 2023, so did the involvement of regulators and policymakers. One of the most recent — and substantive — regulatory standards is the...more

Health Care Compliance Association (HCCA)

Behavioral health, artificial intelligence, and compliance

Technology’s exponential development and use in healthcare provides potentially significant benefits for behavioral health patients but also raises ethical and compliance concerns. The most recent technological advance...more

Robinson+Cole Health Law Diagnosis

ONC’s HTI-1 Final Rule Updates Information Blocking Regulations

On December 13, 2023, the Office of the National Coordinator for Health Information Technology (ONC) issued its final rule entitled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm...more

McDermott Will & Emery

European Health & Life Sciences Symposium 2023 | Key Takeaways

McDermott Will & Emery on

200+ leading individuals in healthcare, life sciences and private equity gathered at the Shangri-La Hotel in Paris for the European Health & Life Sciences Symposium 2023 to enjoy a day packed with fireside chats, in-depth...more

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

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

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2023

Report on Patient Privacy 23, no. 11 (November, 2023) The American Hospital Association (AHA) is urging federal lawmakers to intervene with the HHS Office for Civil Rights (OCR) so that hospitals and health systems can...more

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