On August 8, 2023, the United States Court of Appeals for the Ninth Circuit issued a published opinion holding that conventional text messages do not amount to “artificial or prerecorded voice” calls under the Telephone...more
The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more
8/3/2023
/ 21st Century Cures Act ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Final Rules ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
Information Sharing ,
OIG ,
Physicians ,
Risk Mitigation ,
Webinars
Since the Supreme Court of the United States issued its 2021 ruling in Facebook v. Duguid, which narrowly interpreted the dialing technologies that are considered an automated telephone dialing system (ATDS) regulated by the...more
On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more
7/10/2023
/ 21st Century Cures Act ,
Amended Rules ,
Civil Monetary Penalty ,
CMP Law ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Enforcement Actions ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
Information Technology ,
Investigations ,
OIG ,
Proposed Rules ,
Reporting Requirements
Join Elliot Golding, Daniel Gottlieb and Amy Pimentel for a deep dive into how the new state privacy laws impact the healthcare and financial services industries....more
6/9/2023
/ Banks ,
Continuing Legal Education ,
Data Privacy ,
Financial Institutions ,
Financial Services Industry ,
Health Care Providers ,
Personally Identifiable Information ,
PHI ,
Physicians ,
State Privacy Laws ,
Webinars
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
3/3/2023
/ Data Collection ,
Data Protection ,
Data-Sharing ,
EU ,
European Economic Area (EEA) ,
General Data Protection Regulation (GDPR) ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Personal Information ,
Regulatory Agenda ,
UK
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) issued a Bulletin (Dec. 2022) outlining the obligations for HIPAA covered entities and businesses when deploying online tracking...more
2/10/2023
/ Continuing Legal Education ,
Cookies ,
Covered Entities ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Mobile Apps ,
OCR ,
PHI ,
Unauthorized Disclosure ,
Web Tracking ,
Webinars ,
Websites
On January 17, 2023, the California Health and Human Services Agency (CalHHS) released updated drafts of four policies and procedures (P&Ps) under the California Data Exchange Framework (DxF) to support the implementation of...more
1/30/2023
/ California ,
Comment Period ,
Compliance ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Information Blocking Rules ,
ONC ,
Policies and Procedures ,
Policy Updates
By January 31, 2023, general acute care hospitals, clinical labs and certain physician organizations and medical groups in California are required to enter into the Single Data Sharing Agreement (DSA) to participate in the...more
12/22/2022
/ Acute Facilities ,
California ,
Clinical Laboratories ,
Data Privacy ,
Data Security ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Health and Safety ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Hospitals ,
Personally Identifiable Information ,
Physicians ,
Policies and Procedures ,
Social Services
The US Supreme Court’s recent decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health Organization has raised many questions about potential efforts by law enforcement agencies to obtain data from healthcare and...more
7/11/2022
/ Abortion ,
Biden Administration ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Electronic Protected Health Information (ePHI) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Pregnancy ,
Privacy Concerns ,
Roe v Wade ,
SCOTUS
On June 14, 2021, the US Court of Appeals for the 11th Circuit issued an order withholding issuance of the mandate for its April 21, 2021, holding in Hunstein v. Preferred Collection and Management Services, Inc. In Hunstein,...more
7/8/2021
/ Appeals ,
Consumer Protection Laws ,
Creditors ,
Debt Collection ,
Debt Collectors ,
Debtors ,
Disclosure ,
FDCPA ,
Personal Information ,
Relief Measures ,
Third-Party
On April 1, 2021, the Supreme Court answered a question that has been at the heart of the recent wave of class-action litigation under the Telephone Consumer Protection Act of 1991 (TCPA) in its long-awaited ruling in...more
On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more
12/23/2020
/ 21st Century Cures Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Donations ,
Electronic Medical Records ,
Exceptions ,
Final Rules ,
Hospitals ,
OIG ,
Safe Harbors ,
Software ,
Stark Law ,
Technology
On December 10, 2020, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) with proposed modifications to the Standards for the Privacy of...more
12/18/2020
/ Department of Health and Human Services (HHS) ,
Disclosure ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Access Request ,
HIPAA Privacy Rule ,
Information Requests ,
Medicare ,
NPRM ,
OCR ,
Third-Party
On November 4, 2020, the US Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published an interim final rule with comment period in the Federal Register that...more
On September 17, 2020, the Office of Management and Budget received an Interim Final Rule for review from the Office of the National Coordinator for Health IT (ONC) entitled “Information Blocking and the ONC Health IT...more
Data license agreements have been a hot ticket item of the digital health market and are here to stay. With the exponential growth in licensed data, including de-identified patient data, data license agreement litigation and...more
10/7/2020
/ Asset Protection ,
California Consumer Privacy Act (CCPA) ,
Commercial Litigation ,
Contract Disputes ,
Contract Drafting ,
Contract Interpretation ,
Contract Terms ,
Data Protection ,
De-Identified Protected Health Information ,
Digital Health ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
License Agreements ,
Physicians ,
Regulatory Requirements ,
Remedies ,
Trade Secrets ,
Webinars
On August 31, 2020, the California legislature passed California AB 713, which amends the California Consumer Privacy Act (CCPA) to except from its requirements certain health information, including information that has been...more
9/17/2020
/ California Consumer Privacy Act (CCPA) ,
Data Collection ,
Exceptions ,
Food and Drug Administration (FDA) ,
Governor Newsom ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Life Sciences ,
Patients ,
Personally Identifiable Information ,
State Legislatures
Under the Office of the National Coordinator for Health IT (ONC) 21st Century Cures Act final rule, effective July 1, 2020, health care providers, in their capacities as such, are not subject to civil monetary penalties....more
On April 21, 2020, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) announced that they will...more
As part of the CARES Act signed into law on March 27, 2020, Congress included a provision directing the secretary of Health and Human Services (HHS) to modify long-standing regulatory restrictions under the federal substance...more
On March 9, 2020, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released its long-awaited final rule identifying conduct that does not...more
The Office of the National Coordinator for Health Information Technology recently released a final rule under the 21st Century Cures Act to promote interoperability of health IT and advance access, exchange or use of...more
The Centers for Medicare & Medicaid Services (CMS) published its highly anticipated final rule aimed at enhancing interoperability and increasing patient access to health information. CMS’s final rule will require hospitals...more
3/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Electronic Health Record Incentives ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Information Technology ,
Medicaid ,
Medicare ,
Qualified Health Plans
The ONC's information blocking prohibition applies to certified health IT developers and health care providers, as well as health information exchanges and health information networks. It prohibits certain fees and other...more