Author Archives

J.D. is an attorney.

• The World Health Organization Issues Guidance on Large Multi-Modal AI Models

  By J.D. Kim, Esq. on March 30, 2024 • ( 0 )

  On January 18, 2024, the World Health Organization (WHO) published, “Ethics and governance of artificial intelligence for health Guidance on large multi-modal models,” which follows an earlier 2021 guidance on AI and addresses regulatory issues surrounding generative AI, specifically large… Read More ›

• CMS continues its efforts to increase data transparency and data capabilities in Medicare Advantage by issuing a Request for Information 

  By J.D. Kim, Esq. on March 13, 2024 • ( 0 )

  According to the Centers for Medicare & Medicaid Services (CMS), the Medicare Advantage program has now exceeded 50% of Medicare enrollments and in order to further increase transparency and strengthen programmatic data, on January 25, 2024, the agency issued a… Read More ›

• CMS Interoperability and Prior Authorization Final Rule seeks to improve processes through greater Interoperability  

  By J.D. Kim, Esq. on February 12, 2024 • ( 0 )

  The Center for Medicare & Medicaid Services (CMS) released the CMS Interoperability and Prior Authorization Final Rule on January 17, 2024, which according to CMS.gov “emphasizes the need to improve health information exchange to achieve appropriate and necessary access to… Read More ›

• HHS Health Data, Technology, and Interoperability Final Rule furthers Agency’s effort to build the Digital Foundation for U.S. Health Care

  By J.D. Kim, Esq. on January 30, 2024 • ( 0 )

  After releasing a proposed rule in April 2023, the Office of the National Coordinator for Health Information Technology (ONC) issued the final Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Rule on December 13,… Read More ›

• The DEA extends Telemedicine Prescribing Flexibilities to December 31, 2024, as it continues to seek effective Safeguards against Diversion

  By J.D. Kim, Esq. on December 12, 2023 • ( 0 )

  The U.S. Drug Enforcement Agency (DEA) has recently extended COVID-19 Public Health Emergency (COVID-19 PHE) telemedicine flexibilities with regards to the prescribing of controlled substances until December 31, 2024, as it continues its rulemaking with regards to whether the requirement… Read More ›

• Biden Executive Order Seeks Comprehensive Oversight of AI in Healthcare and Other Fields 

  By J.D. Kim, Esq. on November 15, 2023 • ( 0 )

  On October 30, President Joe Biden issued an Executive Order on the “Safe Secure and Trustworthy Development and Use of Artificial Intelligence,” which includes provisions that will potentially have a broad impact on healthcare as it seeks to ensure the… Read More ›

• FTC’s Proposed Changes Seek to Apply Health Breach Notification Rule to Developers of Health Apps and Similar Technologies

  By J.D. Kim, Esq. on August 9, 2023 • ( 0 )

  Through proposed amendments to its Health Breach Notification Rule (16 CFR Part 318), the FTC is currently seeking to formalize the extension of notification requirements as to covered security breaches of consumers’ electronic health information to developers of health applications… Read More ›

• Proposed HHS Data Interoperability Rule Seeks to Address AI and Bring Certification Program Updates

  By J.D. Kim, Esq. on July 20, 2023 • ( 0 )

  In April of this year, the Department of Health and Human Services (HHS) published a proposed rule concerning data interoperability that is of significant importance to developers of health information technology (health IT).   Having the title, “Health Data, Technology, and… Read More ›

• HHS OIG Establishes Final Rule for Information Blocking Enforcement 

  By J.D. Kim, Esq. on July 6, 2023 • ( 0 )

  On July 3, 2023, a final rule establishing the penalties for information blocking, which according to the HealthIT.gov site refers to practices that are “likely to interfere with the access, exchange, or use of electronic health information (EHI),” was published… Read More ›