On August 29, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) withdrew its appeal of the US District Court for the Northern District of Texas’s June 20, 2024, decision in American...more
9/4/2024
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Appeals ,
Cookies ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
OCR ,
Technology Sector ,
Tracking Systems ,
Web Tracking ,
Websites
On August 19, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) filed a notice of appeal of the US District Court for the Northern District of Texas’s June 20, 2024, decision in American...more
8/28/2024
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Appeals ,
Cookies ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
OCR ,
Technology Sector ,
Tracking Systems ,
Web Tracking ,
Websites
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
In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled in American Hospital Association...more
On February 8, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) jointly issued a final rule to amend the...more
On March 18, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) issued an update to its December 1, 2022, bulletin titled “Use of Online Tracking Technologies by HIPAA Covered Entities and...more
3/22/2024
/ Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Enforcement Priorities ,
Guidance Update ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
PHI ,
Tracking Systems ,
Web Tracking ,
Websites
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more
Online tracking technologies, such as pixels, have become a common feature of the modern web and app ecosystem. Pixels and other online tracking technologies may be configured to collect user data about website visits,...more
9/25/2023
/ Data Collection ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Online Platforms ,
Regulatory Requirements ,
Technology Sector ,
Web Tracking ,
Websites
On Thursday, July 20, 2023, the Federal Trade Commission and HHS Office for Civil Rights issued a rare joint press release announcing that approximately 130 hospital systems and telehealth providers received a letter alerting...more
7/24/2023
/ Data Collection ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
Joint Statements ,
Mobile Apps ,
OCR ,
Telehealth ,
Tracking Systems ,
Websites
On December 1, 2022, the Office for Civil Rights (OCR) at the US Department of Health and Human Services (HHS) issued a Bulletin on the obligations of covered entities and business associates (regulated entities) under the...more
12/6/2022
/ Data Privacy ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Mobile Apps ,
New Guidance ,
OCR ,
Personally Identifiable Information ,
PHI ,
Tracking Systems ,
Web Tracking
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
Hospitals and health systems are facing consumer demand for innovation, the need to expand and enhance streams of revenue and the push for improved quality, all while navigating changing regulations, federal enforcement,...more
2/6/2020
/ Antitrust Litigation ,
Centers for Medicare & Medicaid Services (CMS) ,
CMIA ,
Cyber Attacks ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medicare ,
No-Poaching ,
OCR ,
Popular ,
Ransomware
The US Department of Health and Human Services, Office for Civil Rights (OCR) published a long-awaited Request for Information seeking feedback on whether and how the HIPAA Rules should be revised to better promote...more
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
A complex—and occasionally, inconsistent—patchwork of federal and state regulatory requirements apply to entities that perform human subjects research in the United States. In recognition of one such inconsistency, the...more
The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more
2/7/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Human Rights ,
Informed Consent ,
IRB ,
Medical Devices ,
Medical Research ,
NPRM ,
Proposed Regulation ,
Scientific Research ,
The Common Rule
In Depth -
On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.”...more
On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often...more
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more
Earlier this month, a bipartisan group, led by U.S. Senator Brian Schatz (D-Hawaii), introduced a bill in the Senate focused on promoting cost savings and quality care under the Medicare program through the use of telehealth...more
On January 6, 2016, the U.S. Department of Health and Human Services (HHS) issued a final rule amending the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to strengthen the current background check...more
In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more
9/9/2015
/ Clinical Trials ,
Comment Period ,
Data Security ,
Department of Health and Human Services (HHS) ,
Exemptions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Human Genome Project ,
Informed Consent ,
IRB ,
Jurisdiction ,
Medical Research ,
NPRM ,
Proposed Regulation ,
Recordkeeping Requirements ,
Scientific Research ,
The Common Rule
On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more
On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule (Final Rule) containing modifications to the privacy standards (Privacy Rule), security...more
2/21/2013
/ Business Associates ,
Covered Entities ,
Data Breach ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Enforcement ,
GINA ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Notice Requirements ,
OCR ,
PHI ,
Privacy Rule