News & Analysis as of

Health Information Technologies Regulatory Agenda

McDermott Will & Emery

ASTP Proposes Certification Criteria for Patient, Payer and Provider APIs

On August 5, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

Verrill

Massachusetts Attorney General Artificial Intelligence Guidance: What Healthcare Providers and Health IT Developers Need to Know

Verrill on

With the explosion of Artificial Intelligence (AI) use and application, the Massachusetts Attorney General’s recent release of AI guidelines should serve as a reminder to healthcare providers and health IT developers of the...more

Foley Hoag LLP - Security, Privacy and the...

In Wake of Healthcare System Cyberattack, 22 State Attorneys General Call for Further Action of Data Privacy

On April 25, 2024, the attorneys general of 22 states issued a letter encouraging UnitedHealth Group and its subsidiary, Change Healthcare, to take additional steps to respond to a massively disruptive cyberattack. The broad,...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

Burr & Forman

Proposed Penalties for Information Blocking Violations

Burr & Forman on

On October 30, 2023, the Department of Health and Human Services (HHS) released a proposed rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century...more

Robinson+Cole Health Law Diagnosis

HHS Proposes Disincentives for Providers that Commit Information Blocking

On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information...more

Hogan Lovells

U.S. Senator requests information on ways to improve privacy protections of health data

Hogan Lovells on

Adding to the growing trend of policymakers interested in regulating health and wellness data, last week U.S. Senator Bill Cassidy requested stakeholder feedback to help identify solutions to modernize HIPAA and ensure all...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | June 2023 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more

McDermott Will & Emery

Trending in Telehealth: June 6 – 12, 2023

McDermott Will & Emery on

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies,...more

Akerman LLP - Health Law Rx

Health Apps Beware: FTC Clarifies Health Breach Notification Rule with Significant Proposed Changes

Direct-to-consumer health and wellness applications are forewarned: the Federal Trade Commission (FTC) is proposing changes to the Health Breach Notification Rule (HBNR), 16 C.F.R. part 318, that, if finalized, would cement...more

Polsinelli

Proposed Regulatory Oversight on the Emerging Use of Artificial Intelligence in Digital Health

Polsinelli on

Recent months have seen a heightened interest in artificial intelligence (“AI”)-based technology solutions. Although AI is derived from neural networks that date back to the 1940s, new technologies such as generative AI...more

McDermott Will & Emery

Health Data in the EU and UK – Regulatory Trends and Developments

In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more

Nelson Mullins Riley & Scarborough LLP

FDA Concludes Software Pre-Cert Pilot Program, Noting Federal Legislative Action is Needed

The U.S. Food and Drug Administration (“FDA” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...more

McDermott Will & Emery

2022 J.P. Morgan Healthcare Conference: Healthcare Private Equity Leaders Forum

During this session, leading private equity investors explored key drivers and trends across diverse industry subsectors. They examined how shifting regulations and the upcoming 2022 midterm elections may alter the deal...more

Manatt, Phelps & Phillips, LLP

The Manatt State Cost Containment Update - October 2021: Health Data Corner

The Health Data Corner compiles the latest state health care data capacity innovations and policy developments, as well as showcases novel data analytic use cases emerging from states. Other developments featured here include...more

Foley Hoag LLP - Security, Privacy and the...

Cybersecurity 2020 — The Year in Preview: Changes in Health Data Privacy Legislation

Editors’ Note: This is the fourth in our fourth-annual end-of-year series examining important trends in data privacy and cybersecurity in the coming year. Our previous entry discussed the CCPA, energy, and Brexit. Up next:...more

Bricker Graydon LLP

CMS and OIG propose changes to existing rules for donations of electronic health records and new rules for donations of...

Bricker Graydon LLP on

On October 9, 2019, the Office of Inspector General (OIG) released proposed changes to the regulations interpreting the federal Anti-Kickback Statute (AKS). On the same day, the Centers for Medicare and Medicaid Services...more

Polsinelli

Unique Opportunity to Influence Anti-Kickback Statute Rules

Polsinelli on

Starting today, the industry has 75 days to provide input on the proposed rules published in the Federal Register regarding the future enforcement of the Anti-Kickback Statute (AKS). ...more

Epstein Becker & Green

FTC Submits Comments on Proposed “Information Blocking” Rule in Effort to Protect Market Competition

Epstein Becker & Green on

On June 6, 2019, the Federal Trade Commission (“FTC”) submitted a comment letter regarding a proposed rule by the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology...more

McDermott Will & Emery

ONC Proposes to Define Conduct That Is Not Information Blocking under the Cures Act

McDermott Will & Emery on

The ONC finally released its long-awaited proposed rule to implement the “information blocking” prohibition of the 21st Century Cures Act by identifying conduct that is not information blocking. If finalized, ONC’s proposed...more

Foley & Lardner LLP

Health Care Information Exchanges and Price Transparency Initiatives: CMS Requests Input from Providers

Foley & Lardner LLP on

On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule introducing changes to the Medicare physician fee schedule, and soliciting comments from providers on CMS data sharing initiatives....more

Bradley Arant Boult Cummings LLP

CMS Proposes Significant E/M Coding and Documentation Changes - Healthcare Alert

On July 27, 2018, the Centers for Medicare & Medicaid Services (CMS) published its proposed annual update to the Medicare Physician Fee Schedule, which proposes changes to the E/M coding and documentation process that CMS...more

Foley & Lardner LLP

INSIGHT: CMS’s Virtual Care Codes Pave New Avenues for Telemedicine Services Delivery

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The Centers for Medicare & Medicaid Services issued a proposed rule introducing monumental changes to the physician fee schedule, paving the way for asynchronous telemedicine and new technologies through a new set of virtual...more

Foley & Lardner LLP

Medicare’s New Virtual Care Codes: A Monumental Change and Validation of Asynchronous Telemedicine

Foley & Lardner LLP on

The Centers for Medicare and Medicaid Services just issued a proposed rule introducing monumental changes to the physician fee schedule, paving the way for asynchronous telemedicine and new technologies through a new set of...more

Proskauer Rose LLP

CMS Issues Proposed Rule with Significant Revisions to the Medicare Physician Fee Schedule and Other Payment Policies

Proskauer Rose LLP on

On July 12, 2018, the Centers for Medicare & Medicaid Services ("CMS") issued a proposed rule that includes proposals to update payment policies and rates for services furnished under the Medicare Physician Fee Schedule...more

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