On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.Continue Reading ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI
HHS-OIG Releases Final Rule Implementing Information Blocking Penalties
On June 27, 2023, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“OIG Final Rule”) that implements statutory provisions for its enforcement of the information blocking penalties created by the 21stCentury Cures Act (“Cures Act”) and assessment of civil money penalties (“CMPs”) of up to $1 million per violation of information blocking for certain individuals or entities subject to the information blocking requirements.Continue Reading HHS-OIG Releases Final Rule Implementing Information Blocking Penalties
FTC Announces Enforcement Action Against Ovulation Tracking App Premom
On May 17, 2023, the Federal Trade Commission (“FTC”) announced an enforcement action (“Enforcement Action”) against Illinois-based Easy Healthcare Corporation (“Easy Healthcare”), which operates the Premom application, for allegedly violating Section 5 of the FTC Act and the Health Breach Notification Rule (“HBNR”). Easy Healthcare has developed, advertised, and distributed a mobile application called the Premom Ovulation Tracker (“Premom”) that allows users to input and track various types of personal and health information. In the complaint (“Complaint”), the FTC alleges that Easy Healthcare deceived users by disclosing users’ sensitive health data with third parties and failed to notify consumers of these unauthorized disclosures in violation of the HBNR. The proposed order (“Proposed Order”), which was brought by the U.S. Department of Justice on behalf of the FTC, imposes a civil penalty of $100,000 and prohibits Easy Healthcare from sharing user personal health data with third parties for advertising, among other requirements. As part of a related action, Easy Healthcare has agreed to pay an additional $100,000 to Connecticut, the District of Columbia, and Oregon for violating their respective laws.Continue Reading FTC Announces Enforcement Action Against Ovulation Tracking App Premom
President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions
On December 29, President Joe Biden signed into law the Consolidated Appropriations Act, 2023 (P.L. 117-164) (the “Act”)—an approximately $1.7 trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. Continue Reading President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions
CMS Issues Proposed Rule to Standardize Electronic Health Care Attachments Transactions and Electronic Signature under HIPAA
On December 21, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would adopt standards under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for “health care attachments” transactions, which would: (1) support health care claims adjudication and prior authorization transactions; (2) adopt standards for electronic signatures to
CMS Issues “In Lieu of” Services Guidance to Address Health-Related Social Needs in Medicaid Managed Care
On January 4, in its most recent effort to expand federal support for addressing health-related social needs (HRSNs), the Centers for Medicare & Medicaid Services (CMS) issued guidance to clarify an existing option for states to address HRSNs through the use of “in lieu of” services and settings policies in Medicaid managed care. This option
CMS Issues a New “Advancing Interoperability and Improving Prior Authorization Processes” Proposed Rule
On December 6, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule that would (i) further enhance health data exchange by establishing data exchange standards for certain payers, (ii) improve patient and provider access to health information, and (iii) streamline processes related to prior authorization for medical items and services. The
HHS Issues Proposed HIPAA Rule to Adopt Updated Version of Retail Pharmacy Standards for Electronic Transactions
On November 9, the Department of Health and Human Services (HHS) issued a proposed rule to adopt updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and to broaden the applicability of the HIPAA subrogation transaction.
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Top Healthcare Policy Developments in 2023; Register for Crowell Health Solutions Webinar
The results of the 2022 U.S. midterm elections—during which voters were focused on the economy, public safety, and health care and abortion issues—will have longstanding consequences for the development of health care policy over the next two years. With the U.S. House of Representatives and U.S. Senate controlled by different parties, it will be difficult
HHS OCR Issues a Bulletin on HIPAA Requirements for Tracking Health Information When Using Online Technologies
The Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) recently issued a bulletin to highlight the obligations of Health Insurance Portability and Accountability Act of 1996 (HIPAA) on regulated entities under the HIPAA Privacy, Security, and Breach Notification Rules when using online tracking technologies. The bulletin defines