Below is an excerpt of an article co-authored with Robinson+Cole Construction Law Group lawyer Virginia K. Trunkes and published in Healthcare Facilities Today on March 31, 2021. The need to update and implement new processes for delivering healthcare in response to the COVID-19 pandemic has resulted in the adoption of more automation, remote access and monitoring technologies. It also has brought data analytics into treatment and the patient environment. Healthcare providers have shifted from traditional waiting…

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Connecticut Extends Expansion of Access to Telehealth Services

By Conor Duffy

March 19, 2021

On March 14, 2021, Connecticut Governor Lamont issued Executive Order 10C (EO 10C), which extends provisions of Public Act 20-2 (PA 20-2), a law passed by the Connecticut legislature in July 2020 that “provided additional flexibility for the delivery of telehealth services and insurance coverage of these services” but was scheduled to expire March 15, 2021. As a result of EO 10C, the provisions of PA 20-2 that were scheduled to…

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COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP Act

By Conor Duffy

January 29, 2021

On January 28, 2021, the Department of Health and Human Services (HHS) issued a Fifth Amendment to HHS’s Declaration under the Public Health Readiness and Emergency Preparedness Act (PREP Act) that provides liability immunity to certain individuals and entities arising from the manufacturing, distribution, administration or use of medical countermeasures (e.g., therapeutics and vaccines) against COVID-19.…

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Excellus Health Plan Pays $5.1M to OCR in Settlement Following Data Breach

By Linn Foster Freedman

January 22, 2021

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced that it had entered into a Resolution Agreement, Corrective Action Plan, and settlement with Lifetime Healthcare, Inc., the parent of Excellus Health Plan, over alleged violations of HIPAA relating to a data breach that occurred from December 23, 2013 through May 11, 2015. During that time, a cybercriminal obtained access to its IT systems and installed malware that allowed the…

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Fifth Circuit Overturns “Arbitrary and Capricious” $4.3 Million HIPAA Penalty Against Hospital

By Conor Duffy

January 21, 2021

On January 14, 2021, the U.S. Court of Appeals for the Fifth Circuit overturned a $4.348 million penalty for alleged HIPAA violations assessed by the U.S. Department of Health & Human Services (HHS) against the University of Texas M.D. Anderson Cancer Center (Hospital). The case arises from an enforcement action undertaken by HHS following the Hospital’s self-disclosure of three separate instances of lost or stolen portable devices containing electronic protected health information (ePHI). The government’s…

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OCR Announces it Will Not Impose HIPAA Penalties for Use of COVID-19 Vaccine Scheduling Apps

By Nathaniel Arden

January 21, 2021

The Office of Civil Rights (OCR) issued a notice yesterday stating that it will not impose penalties for HIPAA non-compliance in connection with a covered entity health care provider’s or business associate’s good faith use of online or web-based scheduling applications (WBSAs) for the scheduling of appointments for COVID-19 vaccinations during the public health emergency. The notice is retroactively effective to December 11, 2020. OCR highlights to covered health care providers and business associates that…

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HHS Proposes Modifications to the HIPAA Privacy Rule to Enhance Care Coordination and Management and Remove Barriers to Accessing Information

By Conor Duffy & Jean Tomasco

December 15, 2020

On December 10, 2020, the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, which is one of several rules that protect the privacy and security of individuals’ medical records and other protected health information (PHI). According to HHS, the proposed changes are intended to support individuals’ engagement in their health care, remove barriers to coordinated care and case management, and reduce…

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In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

By Conor Duffy

December 11, 2020

On December 7, 2020, Connecticut Governor Ned Lamont signed Executive Order No. 9Q (the “Order”) in anticipation of the approval of COVID-19 vaccines. The Order addresses and expands COVID-19 vaccine administration, establishes flu vaccine reporting requirements for pharmacists, and limits out-of-network charges for administration of authorized COVID-19 vaccines. Specifically, the Order:…

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HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

By Robinson+Cole's Health Law Group

December 9, 2020

On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil Monetary Penalty (CMP) Rules related to beneficiary inducements. Most of the changes are effective January 19, 2021. Together with the…

Health Law Diagnosis

CMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law Regulations

By Robinson+Cole's Health Law Group

December 4, 2020

On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) published its long-awaited and highly anticipated final rule updating regulations promulgated under the Physician Self-Referral or “Stark” law (the OIG simultaneously published updates to the Anti-Kickback Statute regulations). Among other things, CMS introduced new Stark exceptions for certain “value-based arrangements,” the donation of cybersecurity technology and services and limited remuneration to physicians; introduced new definitions and updated key terms, including “commercial reasonableness,”…

Health Law Diagnosis

Monitoring the Pulse of Health Care and Life Sciences

Blog Authors

Construction and Maintenance: Connectivity and Cyber Security Considerations

Connecticut Extends Expansion of Access to Telehealth Services

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP Act

Excellus Health Plan Pays $5.1M to OCR in Settlement Following Data Breach

Fifth Circuit Overturns “Arbitrary and Capricious” $4.3 Million HIPAA Penalty Against Hospital

OCR Announces it Will Not Impose HIPAA Penalties for Use of COVID-19 Vaccine Scheduling Apps

HHS Proposes Modifications to the HIPAA Privacy Rule to Enhance Care Coordination and Management and Remove Barriers to Accessing Information

In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

CMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law Regulations

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