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Federal Court Allows UnitedHealthcare AI Coverage Denial Case to Proceed on Contract Claims

By Digital Health Law Group on March 27, 2025 • ( 0 )

On February 13, 2025, a federal court dismissed several state law claims against UnitedHealthcare but allowed breach of contract and good faith claims to proceed in a case alleging improper use of AI to deny medical coverage. More specifically, the… Read More ›
Artificial Intelligence in Medical Devices: FDA Releases Draft Guidance for Lifecycle Management and Marketing

By Digital Health Law Group on January 28, 2025 • ( 0 )

The U.S. Food and Drug Administration recently issued its first-ever draft guidance on the use of AI for the development of drug and biological products. Entitled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” it serves as… Read More ›
HHS Releases Comprehensive AI Strategic Plan

By J.D. Kim, Esq. on January 18, 2025 • ( 0 )

The Department of Health and Human Services (HHS) released its AI Strategic Plan in January 2025, establishing a comprehensive approach to artificial intelligence. The Plan’s Overview states that it “provides a framework and roadmap to ensure that HHS fulfills its… Read More ›
Proposed 2026 MA Rule: Changes to Internal Coverage Criteria and Prior Authorization Requirements

By Digital Health Law Group on December 27, 2024 • ( 0 )

The Centers for Medicare & Medicaid Services (CMS) has released a proposed rule that would significantly enhance regulations around how Medicare Advantage (MA) organizations use internal coverage criteria, particularly relating to prior authorization and utilization management. The proposed changes, part… Read More ›
California Law Requires Disclosure of AI Use in Healthcare Communications

By Digital Health Law Group on December 18, 2024 • ( 0 )

New legislation in California regulates communications by health care providers who use artificial intelligence in communications with patients. Specifically, an addition to the state’s Health and Safety Code entitled “Artificial Intelligence in Health Care Services” requires a disclaimer that… Read More ›
Senate Investigation Reveals How Medicare Advantage Plans Use Artificial Intelligence to Deny Post-Acute Care

By Digital Health Law Group on December 17, 2024 • ( 0 )

Medicare Advantage insurers are using prior authorization requirements to systematically deny seniors access to post-acute care facilities, according to a recent U.S. Senate investigative report. Dated October 17, 2024, the Majority staff report of the Senate Permanent Subcommittee on Investigations… Read More ›
HHS Information Security Program Rated ‘Not Effective’ for FY 2024

By Digital Health Law Group on December 13, 2024 • ( 0 )

The Department of Health and Human Services’ (HHS) information security program failed to meet federal effectiveness standards according to a November 14, 2024, audit report, signaling important cybersecurity lessons for healthcare entities and digital health companies. Specifically, the report stated… Read More ›
Fate of Cigna PXDX Lawsuit Hangs in Balance as Court Weighs Motion to Dismiss

By Digital Health Law Group on December 12, 2024 • ( 0 )

Earlier this year on September 20, 2024, Plaintiffs filed their Opposition papers to Cigna Corporation’s and Cigna Health and Life Insurance Company’s (collectively, “Cigna”) motion to dismiss their lawsuit challenging Cigna’s use of an AI algorithm to allegedly automatically deny… Read More ›
Proposed 2026 MA Rule: Changes to Prior Authorization Rules to Advance Health Equity

By Digital Health Law Group on December 11, 2024 • ( 0 )

CMS is proposing revisions to the required metrics for the annual health equity analysis of the use of prior authorization. Under the proposed changes, MA organizations would have to report the metrics for the analysis by each item or service,… Read More ›
CMS Proposes New Rules for AI Use in Medicare Advantage Plans

By Digital Health Law Group on December 3, 2024 • ( 0 )

New regulations requiring Medicare Advantage (MA) organizations to ensure non-discriminatory use of artificial intelligence and automated systems have been proposed by the Centers for Medicare & Medicaid Services (CMS). These AI provisions are part of a broader proposed rule titled… Read More ›

Featured Categories

Cybersecurity ›

HHS Information Security Program Rated ‘Not Effective’ for FY 2024
December 13, 2024
Cybersecurity and HIPAA: NIST’s 2024 Resource Guide for Regulated Entities
May 22, 2024
HHS releases Cybersecurity Performance Goals for the Healthcare and Public Health Sector
May 4, 2024
2024-2030 Federal Health IT Strategic Plan Draft released
April 13, 2024
White House Office of Management and Budget releases Policy Memorandum on use of AI in Federal Agencies
April 9, 2024

TELEHEALTH ›

DEA TELEMEDICINE PRESCRIBING RULES TRACKING
2008 Ryan Haight Online Pharmacy Consumer Protection Act (Ryan Haight Act)
March, 2020 DEA Grants COVID-19 Public Health Emergency (PHE) Exceptions to Ryan Haight Act
3/1/2023 DEA Publishes the General Telemedicine & Buprenorphine Notices of Proposed Rulemaking
5/11/2023 DEA's First Extension of COVID-19 PHE Exceptions Begin, Coinciding with the End of the PHE
September 2023 DEA Holds Public Listening Sessions to Better Inform Rulemaking
11/11/2023 DEA's 2nd Extension of the COVID-19 PHE Exceptions Begins
Fall, 2024 DEA states it is Working to Promulgate new Standards or Safeguards by this Time-frame
12/31/2024 Expiration Date for Second Extension of COVID-19 PHE Exceptions

HOSPITAL PRICE TRANSPARENCY RULE TRACKING (45 CFR 180)
Beginning on 1/1/2024
- Hospitals subject to the Rule must make a good faith effort to ensure that their standard charge information in machine-readable files is true, accurate and complete (45 CFR 180.50(a)(3)(i)).
- Hospitals subject to the Rule must ensure that the public website they select to host their machine-readable file establishes a .txt file and a link in the footer of the website labelled "Price Transparency" that links directly to the publicly available web page that hosts the link to the machine-readable file as further specified in 45 CFR 180.50(d)(6).
Prior to 7/1/2024
- Hospitals subject to the Rule must include all data required by 45 CFR 180.50(b)(1) such as descriptions of each item or service provided by the hospital and gross charge information.
- Prior to this date, required information must be published in a single digital file that is in machine-readable format pursuant to 45 CFR 180.50 (c)(1).
Beginning 7/1/2024
- Hospitals subject to the Rule must affirm in their machine-readable files that they have included all applicable standard charge information and otherwise complied with 45 CFR 180.50(a)(3)(ii).
- Hospitals subject to the Rule must also encode in their machine-readable files all standard charge information required under 45 CFR 180.50(b)(2), such as hospital name, license number, location, and each type of standard charge.
- The machine-readable files of hospitals subject to the Rule must conform to a CMS template layout, data specifications, and data dictionary and hospitals must otherwise comply with 45 CFR 180.50(c)(2).