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Electronic Health Record Incentives

McDermott Will & Emery

FTC Amends Health Breach Notification Rule to Regulate Health Apps and Expand Breach Notification Requirements

McDermott Will & Emery on

On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a complement and counterpart to the breach notification requirements...more

Manatt, Phelps & Phillips, LLP

Changes to the Substance Use Disorder Confidentiality Regulation: Implications for Stakeholders

Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more

McDermott Will & Emery

HHS Issues Provider Information Blocking Disincentives Proposed Rule

McDermott Will & Emery on

On October 30, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) released a...more

Holland & Knight LLP

HHS Proposes Information Blocking Disincentives for Healthcare Providers

Holland & Knight LLP on

Two divisions of the U.S. Department of Health and Human Services (HHS) – the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator (ONC) – released the "21st Century Cures Act:...more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more

Shumaker, Loop & Kendrick, LLP

Florida Electronic Health Records Exchange Act Effective July 1

Florida has a new law as of July 1, 2023 relating to the storage of certain health records. The newly enacted Florida Statutes section 408.051 creates the “Florida Electronic Health Records Exchange Act.” The Act states in...more

Davis Wright Tremaine LLP

Deadline Approaching for Comments on Proposed Changes to Substance Use Disorder Confidentiality Rule

The Department of Health and Human Services ("HHS") has proposed amendments to the Confidentiality of Substance Use Disorder Patient Records Rule, 42 C.F.R. part 2 (the "Part 2 Rule") with a comment deadline of January 31....more

The Volkov Law Group

Modernizing Medicine Settles False Claims Act Violations for $45 Million

The Volkov Law Group on

The Justice Department continues to pile up healthcare enforcement actions — false claims, anti-kickback, and fraud.  DOJ is on its way to a record year....more

WilmerHale

The European Commission publishes its proposal on the European Health Data Space (EHDS)

WilmerHale on

On May 3, 2022, the European Commission published a proposal for a Regulation on the European Health Data Space (EHDS) (“EHDS Regulation”, or “Proposal”). With the Proposal, the European Commission aims to make significant...more

Tarter Krinsky & Drogin LLP

The Anti-Kickback Statute and its Implications on Medical Practices

The Anti-Kickback Statute (AKS) protects healthcare beneficiaries from the influence of money in their medical decision-making. Overall, the AKS criminalizes renumeration “intended to induce patient referrals or influence the...more

Mintz - Health Care Viewpoints

Information Blocking Rule: Key Considerations for 2022

While the Office of the National Coordinator for Health Information Technology (ONC) issued the 21st Century Cures Act; Interoperability, Information Blocking, and the ONC Health IT Certification Program (Information Blocking...more

Skadden, Arps, Slate, Meagher & Flom LLP

Navigating Relationships With Practice Support and Other Tech Vendors

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Q2 2021

In this issue, we discuss U.S. Food and Drug Administration (FDA) regulation of wellness devices. We also look at good commercial contracting hygiene for digital health start-ups. Other articles include recent enforcement...more

Tucker Arensberg, P.C.

Proposed HIPAA Changes Intended to “Empower Patients” and “Improve Coordination of Care”

Tucker Arensberg, P.C. on

On December 10, 2020, the Department of Health and Human Services (HHS) and the Office of Civil Rights (OCR) collaborated on announcing proposed HIPAA changes, intended to “empower patients” and “improve coordination of...more

Bricker Graydon LLP

Recent kickback cases yield almost $20 million in settlements for the United States

Bricker Graydon LLP on

The Department of Justice (DOJ) and U.S. Attorney’s Offices have been quite busy settling False Claims Act (FCA) cases during the first month and a half of 2021. Two recent FCA lawsuits based, at least in part, on allegations...more

Mintz - Health Care Viewpoints

HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part V: Cybersecurity...

On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come...more

King & Spalding

Major Changes Finalized to Stark Rules, Anti-Kickback Statute Safe Harbors and the Beneficiary Inducements CMP

King & Spalding on

CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...more

King & Spalding

HHS Issues Final Rules Implementing Stark Law and Anti-Kickback Statute Reforms

King & Spalding on

On Friday of last week, HHS published two long-awaited final rules implementing significant changes to the regulations under the Stark Law and Anti-Kickback Statute (AKS). The two final rules are: (i) Revisions to the Safe...more

Holland & Hart - Health Law Blog

Final Rules for Stark and Anti-Kickback Reforms Issued by CMS and OIG

On November 20, 2020 the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) issued two final rules to modernize and clarify the Physician...more

Faegre Drinker Biddle & Reath LLP

Revised EHR Donation Rule Published

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) each published a final rule (collectively, the Final...more

Troutman Pepper

FDA Launches Digital Center of Excellence and ONC Updates HIPAA Security Risk Assessment Tool

Troutman Pepper on

Why It Matters - In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more

Shook, Hardy & Bacon L.L.P.

Privacy and Data Security Alert | ONC and CMS Final Rules

Aimed at enabling greater patient access and mandating interoperability, recent Final Rules from the Office of the National Coordinator for Health IT (“ONC”) and the Centers for Medicare and Medicaid Services (“CMS”) have put...more

Seyfarth Shaw LLP

CMS Announces Extension on Publishing Final Rule Governing Physician Self-Referrals in Stark Law

Seyfarth Shaw LLP on

Health care providers looking for long-awaited answers to new proposed rules changes governing physician self-referral arrangements may have to wait a bit longer. ...more

Fox Rothschild LLP

“I Have An App For That”: ONC’s Information Blocking Rule And HIPAA Access Rights

Fox Rothschild LLP on

A patient asks her doctor to send her test results to an app the patient has downloaded on her phone. The doctor worries that the app is not secure and that the patient might not understand the security risks. What should...more

Bricker Graydon LLP

Deadline approaching to submit promoting interoperability hardship exception to avoid payment adjustment

Bricker Graydon LLP on

The Centers for Medicare & Medicaid Services (CMS) requires all hospitals to meaningfully use certified electronic health record technology (CEHRT) as part of the Medicare Promoting Interoperability Program. Eligible...more

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