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NY AG Announces Settlements with Three Mobile-Health App Developers Over Privacy, Marketing Concerns

On March 23, 2017, New York State Attorney General Eric T. Schneiderman announced settlements with three mobile health application (app) development companies aimed at curbing deceptive marketing practices and inadequate...more

Florida Supreme Court Rejects PSQIA Preemption of Florida Constitution

On January 31, 2017, the Florida Supreme Court held that adverse medical incident reports produced in accordance with Florida law cannot constitute confidential and privileged patient safety work product (PSWP) under the...more

Second Circuit Denies En Banc Rehearing in Microsoft Email Case

On January 24, 2017, the U.S. Court of Appeals for the Second Circuit denied the Department of Justice’s request for an en banc rehearing in In the Matter of a Warrant to Search a Certain Email Account Controlled and...more

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

OIG Recognizes New Local Transportation Safe Harbor and Exceptions to CMP in Updated Fraud and Abuse Regulations

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more

21st Century Cures Act Includes Prohibition on Information Blocking and Mandates for Additional HIPAA Guidance

On November 30, 2016, the U.S. House of Representatives voted strongly in favor of the 21st Century Cures Act (the Act), an expansive health bill that addresses the discovery and development of new medical therapies as well...more

CMS Finalizes MACRA Rule and Continues Transition Toward Value-based Payments

On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released a final rule with comment period (Final Rule) implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The Final Rule...more

Sixth Circuit: Substantial Risk of Harm and Mitigation Costs Sufficient to Confer Standing in Data Breach Case

On October 12, 2016, the U.S. Court of Appeals for the Sixth Circuit denied a petition for an en banc rehearing of its September 12 decision in Galaria, et al. v. Nationwide Mutual Insurance Company (Nos. 15-3386/3387). In...more

Third Circuit Delivers Resounding Victory for FTC in Pennsylvania Hospital Merger Case

On September 27, 2016, the U.S. Court of Appeals for the Third Circuit handed the Federal Trade Commission (FTC) a significant antitrust victory by granting its request for a preliminary injunction to stay the pending merger...more

Health Law Pulse - September 2016

DOJ, NY AG REACH SETTLEMENT WITH HOSPITALS IN LANDMARK 60 - DAY RULE CASE - On August 24, 2016, the U.S. attorney for the Southern District of New York and the New York State attorney general announced a $2.95 million...more

CMS Issues Warning to Nursing Homes Regarding Abuse of Residents Via Social Media

On August 5, 2016, the Centers for Medicare & Medicaid Services (CMS) issued guidance to nursing homes in a letter to state survey agencies that addresses nursing homes’ obligations to protect residents. The Letter focuses on...more

HHS: Ransomware Attacks Likely HIPAA Breaches In Absence of Encryption

On July 11, 2016, the U.S. Department of Health & Human Services (HHS) issued a Fact Sheet that provides guidance on (i) how HIPAA Security Rule compliance can assist health care organizations combat ransomware attacks, and...more

Health Law Pulse - July 2016

On June 14, 2016, a federal district court in the Northern District of Illinois denied a request from the Federal Trade Commission (FTC) for a preliminary injunction to enjoin the pending merger of Advocate Health Care...more

Connecticut Legislative Update: Public Act 16-77: An act concerning patient notices, designation of a health information...

This legislation (P.A. 16-77) makes substantive and technical changes related to Public Act 15-146, a major public health and health care bill passed by the Connecticut Legislature during its 2015 Legislative Session....more

Medicare Launches Home Health Pre-Claim Review Demonstration in Five States

The Centers for Medicare and Medicaid Services (CMS) recently announced it will implement a pre-claim review demonstration for home health services. The three-year demonstration will apply to home health services performed in...more

HHS guidance seeks to clarify scope of PSQIA

On May 24, 2016, the Department of Health & Human Services (HHS) issued guidance (Guidance) to health care providers and patient safety organizations (PSOs) in an attempt to clarify the definition of patient safety work...more

Health Law Pulse - June 2016

On May 9, 2016, a federal district court for the Middle District of Pennsylvania rejected a request from the Federal Trade Commission (FTC) for a preliminary injunction to enjoin the pending merger (Merger) between Penn...more

Connecticut Legislature Passes Bill Limiting Physician Non-Compete Agreements

The Connecticut legislature recently passed Public Act No. 16-95 (PA 16-95), which aims to increase competition among health care providers by, among other things, restricting physician non-compete agreements. Though passed...more

OIG laments failure to comprehensively address EHR fraud

The U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) recently released a compendium (Compendium) of its top unimplemented recommendations. The Compendium comprises 25 unimplemented past OIG...more

Internal Revenue Service Issues Proposed Regulations Affecting Type I and Type III Supporting Organizations

On February 19, 2016, the IRS issued proposed regulations regarding Type I and Type III supporting organizations (Proposed Regulations). The Proposed Regulations implement amendments to Section 509(a)(3) of the Internal...more

Physical therapy provider’s patient testimonials lead to $25,000 OCR settlement and admission of civil liability

On February 16, 2016, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) announced that it had entered into an agreement with Complete P.T., Pool & Land Physical Therapy, Inc. (CPT), a physical...more

Connecticut Governor Dannel P. Malloy Establishes Certificate of Need Task Force and Places Temporary Moratorium on Certain...

On February 25, 2016, Connecticut Governor Dannel P. Malloy issued Executive Order No. 51 (Executive Order), which establishes a taskforce (Taskforce) to study and provide recommendations on the state’s certificate of need...more

CMS Finalizes 60-Day Rule Overpayment Regulations

On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) released a final rule (Final Rule) interpreting the application of Section 1128J(d) of the Social Security Act (the 60-Day Rule) to over payments...more

CMS Issues Final Rule Implementing Mandatory Bundled Payment Program for Lower Extremity Joint Procedures

The Centers for Medicare & Medicaid Services (CMS) recently issued a final rule (Final Rule) that implements the Comprehensive Care for Joint Replacement model (CJR Model), a new bundled payment program covering certain...more

HHS issues new guidance on individual access to PHI under HIPAA

On January 7, 2015, HHS issued new guidance (Guidance) regarding an individual’s right to access his or her health information under HIPAA’s Privacy Rule. The Guidance emphasizes that HIPAA, while protecting the privacy and...more

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