HHS Secretary Announces Department Reorganization. In a press release, Robert F. Kennedy, Jr, Secretary of the Department of Health and Human Services (HHS), announced a restructuring in accordance with President Trump's Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” The Department estimates the restructuring will save taxpayers $1.8 billion per year through a workforce reduction of about 10,000 full-time employees. When combined with HHS’ other efforts, including employees accepting early retirement, the restructuring will result in a total downsizing from 82,000 to 62,000 full-time employees. In addition, the Department is seeking to streamline functions by consolidating its 28 divisions into 15 new divisions. This will include a new Administration for a Healthy America, or AHA, and will centralize core functions such as Human Resources, Information Technology, Procurement, External Affairs, and Policy. The current 10 regional offices will be reduced to 5.

Other actions include:

• The Food and Drug Administration will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. According to the Department, this reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.
• The Centers for Disease Control (CDC) will decrease its workforce by approximately 2,400 employees, with a focus on returning to its core mission of preparing for and responding to epidemics and outbreaks. This includes moving ASPR under CDC to enhance coordination of response efforts. The Department notes that the “CDC” decrease would only be 1,400 if you included the individuals coming over from ASPR (approximately 1,000 individuals).
• The National Institutes of Health will decrease its workforce by approximately 1,200 employees by centralizing procurement, human resources, and communications across its 27 institutes and centers.
• CMS will decrease its workforce by approximately 300 employees, with a focus on reducing minor duplication across the agency. According to the Department, this reorganization will not impact Medicare and Medicaid services.
• A new Administration for a Healthy America will consolidate the OASH, HRSA, SAMHSA, ATSDR, and NIOSH in an effort is coordinate chronic care and disease prevention programs and harmonize health resources to low-income Americans. Divisions of AHA include Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce, with support of the U.S. Surgeon General and Policy team.
• HHS will have a new Assistant Secretary for Enforcement to provide oversight of the Departmental Appeals Board (DAB), Office of Medicare Hearings and Appeal (OMHA), and the Office for Civil Rights (OCR) to combat waste, fraud, and abuse.
• HHS will combine the Assistant Secretary for Planning and Evaluation (ASPE) and Agency for Healthcare Research and Quality (AHRQ) into the Office of Strategy to conduct research that informs the Secretary’s policies and evaluates the effectiveness of the Department’s programs for a healthier America.

For additional information on the reorganization, go here to access the fact sheet.

Senate Confirms Heads of FDA and NIH. The U.S. Senate voted largely along party lines to confirm Marty Makary as the commissioner of the FDA and Jay Bhattacharya as NIH director. All Republicans backed Bhattacharya in a 53-47 vote, and all Republicans plus three Democrats backed Makary in a 56-44 vote. Both reiterated Department of Health and Human Services Secretary Robert F. Kennedy’s promises to make America healthy again during their confirmation hearings.

Senate Committee Votes to Move Dr. Oz’s Nomination Forward. The U.S. Senate Committee on Finance voted 14-13 along party lines to move the confirmation of Dr. Mehmet Oz to be Administrator of the Centers for Medicare & Medicaid Services (CMS) forward for a vote by the full Senate.

Dr. Susan Monarez Tapped to Lead CDC. President Trump will nominate Susan Monarez, PhD, the acting director of the CDC, to lead the agency, as reported in Politico. The President withdrew the nomination of his first pick, David Weldon, MD, earlier this month. Monarez came from an outside federal government agency, the Advanced Research Projects Agency for Health Monarez and has been serving as the CDC's acting director since January. Prior to serving as the CDC’s acting head, Monarez was a leader in the artificial intelligence and health technology space and has served at the White House in the Office of Science and Technology Policy and on the National Security Council.

OCR Settles HIPAA Security Rule Investigation for $227k. The HHS Office for Civil Rights (OCR) announced a settlement with a health fitness company located in Illinois, that provides wellness plans to clients across the country, resolving a potential violation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. The settlement marks the fifth enforcement action in OCR’s Risk Analysis Initiative.  This enforcement initiative was created to focus select investigations on compliance with the HIPAA Security Rule Risk Analysis provision, a key Security Rule requirement, and the foundation for effective cybersecurity and the protection of ePHI; to increase the number of completed Security Rule investigations involving potential violations of the Risk Analysis provision; and to highlight the critical need for organizations to prioritize compliance with this foundational HIPAA Security Rule requirement.

The settlement resolves OCR’s investigation of the organization, which OCR initiated after receiving four reports from them of breaches of unsecured protected health information over a three-month period (October 15, 2018, to January 25, 2019). The entity filed the breach reports on behalf of multiple covered entities as their business associate.  They reported that beginning approximately in August 2015, ePHI became discoverable on the internet and was exposed to automated search devices (web crawlers) resulting from a software misconfiguration on the server housing the ePHI. They discovered the breach on June 27, 2018, and initially reported that approximately 4,304 individuals were affected and later estimated that the number of individuals affected may be lower.  OCR’s investigation determined that the organization had failed to conduct an accurate and thorough risk analysis, until January 19, 2024, to determine the potential risks and vulnerabilities to the ePHI.

Under the terms of the resolution agreement, the organization agreed to implement a corrective action plan that OCR will monitor for two years and paid $227,816 to OCR.  Under the corrective action plan, the organization committed to taking steps to ensure compliance with the HIPAA Security Rule and protect the security of ePHI, including:

• Annually reviewing and updating as necessary its risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
• Developing and implementing a risk management plan to address and mitigate security risks and vulnerabilities identified in its risk analysis;
• Implementing a process for evaluating environmental and operational changes that affect the security of ePHI; and
• Developing, maintaining, and revising, as necessary, certain written policies and procedures to comply with the HIPAA Privacy, Security, and Breach Notification Rules.

The resolution agreement and corrective action plan may be found here.

NIST Finalizes Guidelines on Mitigating Cyberattacks Against AI. The National Institute of Standards and Technology (NIST) finalized guidelines entitled Adversarial Machine Learning: A Taxonomy and Terminology of Attacks and Mitigations. The guidelines were developed to address attacks on artificial intelligence (AI) systems to make them malfunction and highlight how to identify and mitigate these attacks. The guidelines include a number of revisions from the draft publication aimed at AI developers and users. These include: (i) the section on GenAI attacks and mitigation methods has been updated and restructured to reflect the most recent developments regarding these technologies and how businesses are using them; and (ii) a new section, an index of attacks and mitigations, has been added to allow for fine-grain definition and navigation of attacks. Go here to access additional information.

Article: Can Artificial Intelligence Replace Radiologists? An article in Medpage Today explored whether artificial intelligence (AI) has the ability to replace radiologists. The short answer is no. The author notes that the AI models currently used in radiology are narrow in scope and useful in highly specific tasks. To fully replace a radiologist, however, an AI model would need to accurately interpret thousands of imaging findings across the entire body, perform clinical reasoning, and integrate other inputs, such as lab values and the patient's medical history. In addition, the author states that radiologists also engage in frequent communication with other physicians, discussing imaging findings on the phone or in person to help guide clinical decisions. They also play a vital role in tumor boards, actively contribute to the multidisciplinary management of complex cases, and often speak directly with patients to discuss sensitive topics, such as abnormal results.