| Triple Play: HHS Issues Three New Final Rules - Compliance Dates and Steps to Take Now
Presenter: Rachel Rose, JD, MBA
Time: 1.02 Hours
Description: In early 2024, the U.S. Department of Health and Human Services issued three new final rules: 42 CFR Part 2, HIPAA Privacy Rule to Support Reproductive Healthcare Privacy, and Preventing Non-Discrimination and Advancing Civil Rights in Healthcare. Rachel Rose, Attorney at Law, delves into each, including implementation dates and compliance steps to take now.
Objectives:
- Discuss headline highlights.
- Study relevant history.
- Understand the HIPAA Privacy Rule on reproductive healthcare.
- Recognize confidentiality of Substance Use Disorder (SUD) patient records regulations at 42 CFR Part 2.
- Appreciate the new rule to strengthen nondiscrimination protections and advance civil rights in healthcare.
- Review compliance considerations.
Key Topics:
Headline Highlights – FTC
• FTC Finalizes Changes to the Health Breach Notification Rule
• HBNR Background
• HBNR Enforcement Not Until 2023!
• Notable Terms
Relevant History – Legislative and Regulatory History
• Legislative History
• HIPAA Security Requirements
• The HITECH Act & HR 7898
• Psychotherapy Notes
HIPAA Privacy Rule – Reproductive Healthcare
• UNION PAC. RY. CO. v. BOTSFORD, 141 U.S. 250 (May 25, 1891)
• U.S. Constitution Privacy Provisions
• Roe and Casey
• Dobbs v. Jackson Women's Health Organization (Decided June 24, 2022)
• Majority and Dissent – Dobbs & Privacy
• HIPAA Considerations
• HIPAA Law Enforcement Exception
• HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Healthcare
• OMB Clears Final Rule on HIPAA Privacy Protections for Reproductive Health Information
• Key Points
Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”) - Interplay between SAMHSA and OCR
• 42 CFR Part 2 (“Part 2”)
• Key terms – WHO FALLS UNDER SAMHSA & Part 2?
• 42 CFR Part 8 – Final Rule (Opioid Treatment Programs)
• February 8, 2024 HHS Bulletin
• Final Rule – Aligning Part 2 with HIPAA
• The Final Rule Includes the Following Modifications to Part 2 That Were Proposed in the NPRM
• And What Substantive Changes Have Occurred Since the Notice of Proposed Rule Making, Which Are a Direct Result of the Public Comments During the NPRM Period?
• How Is Part 2 Patient Data Exchanged?
New Rule to Strengthen Nondiscrimination Protections and Advance Civil Rights in Healthcare - Notable Item – AI
• Items to Know
• Part B Changes
• Artificial Intelligence (AI) – Part A
• Artificial Intelligence (AI) - Part B
• Additional Highlights
Compliance Considerations - Mitigating Risk
• Compliance Programs in Healthcare
• HHS-OIG Guidance 2023
• NIST SP 800-66r2, Implementing the HIPAA Security Rule: A Cybersecurity Resource Guide
Conclusion - Take-Aways
Speaker Rachel V. Rose, JD, MBA - Principal. https://www.rvrose.com/ Ms. Rose has a unique background. Throughout her career, she has accumulated knowledge in a multitude of fields, with an emphasis on various facets of healthcare. Her experiences include: - working on Wall Street and at one of the "Big Four" consulting firms;
- producing for the Chairman of the Reform and Oversight Committee on Capitol Hill;
- interning at the Department of Health and Human Services;
- compiling policy papers at the Royal College of Nursing in London;
- consultative work as a top performing representative for the pharmaceutical and medical device industry;
- clerking for the Honorable Linda R. Allan (6th Judicial Circuit, FL).
Prior to opening her law firm, she was Director of Business Development and Assistant General Counsel for a healthcare advisory company. She is extensively published and presents on a variety of healthcare, False Claims Act and securities law topics including: cybersecurity, qui tam, physician reimbursement, ICD-10, access to care, anti-kickback and Stark laws, U.S. Supreme Court cases impacting the medical device industry, international comparative healthcare laws, and the HIPAA/the HITECH Act.
Presently, she is the immediate past-chair of the Federal Bar Association's Corporate and Associations Counsel Division (2014-2016), one of eighteen lawyers, who serves on the Federal Bar Association's Government Relations Committee. Ms. Rose has co-authored The American Bar Association's books - The ABCs of ACOs and What Are International HIPAA Considerations?, as well as being a co-editor of American Health Lawyers Association’s Enterprise Risk Management Handbook (2nd Edition). Ms. Rose is also an Affiliated Member of the Baylor College of Medicine's Center for Health Policy and Medical Ethics, where she teaches bioethics and is on the University of Houston Law School's Healthcare Law Advisory Board.
Education - Bachelor of Arts- History (The Pennsylvania State University)
- Master of Business Administration (Vanderbilt University)
- Doctorate of Jurisprudence (Stetson University College of Law); Editor, The Journal of International Law and Aging
Honors and Awards - National Scribes Award
- The William F. Blews Pro Bono Service Award
- Federal Bar Association Fellow
- Named to Texas Bar College
- National Women Trial Lawyers Association - Top 25,, 2018 and 2019
- Houstonia Magazine's Top Lawyers- Healthcare Law, 2018 and 2019
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