The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
1/30/2024
/ AAMC ,
Cancer ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
GAO ,
Healthcare ,
Legislative Agendas ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OSTP ,
Proposed Legislation ,
Proposed Regulation ,
Regulatory Requirements ,
Scientific Research ,
Technology
If the penultimate enforcement settlement of 2023 issued by the HHS Office for Civil Rights (OCR) sounds familiar, that’s with good reason. And the last one of the year should ring some bells, too....more
1/17/2024
/ Amended Rules ,
Corrective Action Plans (CAPs) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Employee Training ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Breach ,
HIPAA Security Rule ,
HIPAA Violations ,
OCR ,
PHI ,
Policies and Procedures ,
Proposed Regulation ,
Regulatory Reform ,
Right-To-Access ,
Security Risk Assessments ,
Settlement
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more
12/22/2023
/ Bayh-Dole Act ,
Comment Period ,
Compliance ,
Department of Health and Human Services (HHS) ,
Falsified Documents ,
Fraud ,
Healthcare ,
HHS Office of Research Integrity (ORI) ,
Inventions ,
Life Sciences ,
March-in-Rights ,
Medical Research ,
National Science Foundation ,
NIST ,
OIG ,
Patents ,
Scientific Research ,
Technology ,
U.S. Commerce Department ,
Universities ,
USPTO
Report on Patient Privacy 23, no. 12 (December, 2023)
Spring 2020 was a terrifying period in the annals of COVID-19, and New York was at the epicenter. COVID-19 cases, and deaths, already the highest in the nation, were...more
12/8/2023
/ Coronavirus/COVID-19 ,
Corrective Action Plans (CAPs) ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
HIPAA Privacy Rule ,
HIPAA Violations ,
Hospitals ,
Media ,
OCR ,
Patients ,
Personal Information ,
Photographs ,
Prior Authorization ,
Privacy Laws ,
Public Health Emergency ,
Settlement ,
Video
Report on Research Compliance 20, no. 12 (December 2023)
In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
11/27/2023
/ Comment Period ,
Compliance ,
Department of Health and Human Services (HHS) ,
Disclosure ,
Extensions ,
Food and Drug Administration (FDA) ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
NPRM ,
Proposed Regulation ,
Regulatory Requirements ,
Rulemaking Process ,
Scientific Research ,
Universities
Report on Research Compliance Volume 20, no. 10 (October, 2023)
The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will have two new members when it meets this month. In an email sent to its...more
9/26/2023
/ Build America Investment Initiative ,
Compliance ,
Department of Health and Human Services (HHS) ,
Ethics ,
Falsified Documents ,
Federal Funding ,
Guidance Update ,
HHS Office of Research Integrity (ORI) ,
Infrastructure Investment and Jobs Act (IIJA) ,
Investigations ,
Office for Human Research Protections (OHRP) ,
OMB ,
Research and Development ,
Research Funding ,
SACHRP ,
Willful Misconduct
Start with a records request. Add a seven months’ wait. Stir in the chaos of the pandemic, with most employees working from home. Blend in a perhaps-neglected post office box. Bake for two-and-a-half years....more
A criminology professor at Florida State University (FSU), dogged by accusations of research misconduct and the subject of multiple probes, was terminated last month, according to a letter published by Retraction Watch. Hired...more
8/30/2023
/ AAMC ,
Artificial Intelligence ,
Audits ,
Department of Health and Human Services (HHS) ,
Institutional Review Board (IRB) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Negligence ,
Office for Human Research Protections (OHRP) ,
OIG ,
Professional Misconduct ,
Validation and Re-Validation Requirements
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more
8/30/2023
/ 21st Century Cures Act ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Informed Consent ,
Institutional Review Board (IRB) ,
Office for Human Research Protections (OHRP) ,
Proposed Rules ,
Reimbursements ,
Rulemaking Process ,
SACHRP
Report on Research Compliance Volume 20, no 8 (August 2023)
With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more
8/1/2023
/ Department of Health and Human Services (HHS) ,
Enforcement ,
Final Rules ,
Financial Fraud ,
Fines ,
Fraud ,
Fraud and Abuse ,
Grants ,
Health Care Providers ,
Healthcare ,
Information Blocking Rules ,
Medical Research ,
OIG ,
Penalties ,
Research and Development
Report on Patient Privacy Volume 23, no 7 (July 2023)
In two public talks this spring, Melanie Fontes Rainer, director of the HHS Office for Civil Rights (OCR), said completing the 2021 proposed regulation extensively...more
7/17/2023
/ Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
HIPAA Privacy Rule ,
HIPAA Violations ,
Information Blocking Rules ,
Information Technology ,
Investigations ,
OCR ,
Penalties ,
Proposed Regulation ,
Regulatory Requirements
Five Years After ‘a Singular Human Error,’ Two Breach Notices, Revenue Firm Settles With OCR -
As far as settlements for alleged HIPAA violations go, a recent agreement announced by the HHS Office for Civil Rights (OCR)...more
6/9/2023
/ Data Breach ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
File Transfer Protocols (FTP) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Violations ,
OCR ,
PHI ,
Risk Assessment ,
Settlement ,
State Data Breach Notification Statutes ,
Subcontractors
After reviewing recommendations from its Office of Inspector General (OIG), the National Science Foundation (NSF) required Yale University to repay $172,213 of the $251,973 auditors flagged in a 2020 report. According to a...more
After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.” The industry to which the Democratic...more
HIPAA covered entities (CEs) longing for the opportunity to dispense with what some would call the more nettlesome aspects of notices of privacy practices (NPPs) will just have to be patient. For how long, no one is saying....more
5/12/2023
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
HIPAA Privacy Rule ,
OCR ,
Patient Privacy Rights ,
PHI ,
Proposed Amendments ,
Proposed Rules ,
Reproductive Healthcare Issues
Report on Research Compliance Volume 20, Number 5. April 27, 2023 -
- NIH should conduct “site visits to foreign facilities that perform NIH-funded animal research” or require third-party verification to offer “reasonable...more
5/1/2023
/ Academic Misconduct ,
Compliance ,
Department of Health and Human Services (HHS) ,
False Statements ,
GAO ,
Grants ,
HHS Office of Research Integrity (ORI) ,
National Institute of Health (NIH) ,
OIG ,
Professional Misconduct ,
Scientific Research ,
Technology
Report on Research Compliance Volume 20, Number 3. February 23, 2023 -
The Office of Management and Budget (OMB) is planning to revise the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for...more
2/27/2023
/ Audits ,
Build America Investment Initiative ,
Buy American Act ,
Compliance ,
Corrective Actions ,
Department of Health and Human Services (HHS) ,
GAO ,
Hackers ,
Health Technology ,
HIPAA Breach ,
HIPAA Privacy Rule ,
Infrastructure ,
National Institute of Health (NIH) ,
National Science Foundation ,
OCR ,
OIG ,
OMB ,
PHI ,
Proposed Rules ,
Repayment Options ,
Request For Information ,
Uniformity
Report on Patient Privacy Volume 23, no 2 (February 2023)
When Micky Tripathi’s mom was recently transferred to a rehab facility to recover from a broken hip, the hospital, “right in front of me…printed off her record,...more
2/16/2023
/ Compliance ,
Data Privacy ,
Data Security ,
Data Storage ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Electronic Medical Records ,
Enforcement ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
ONC ,
PHI ,
Regulatory Agenda
The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more
12/28/2022
/ Clinical Trials ,
Compliance ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Hiring & Firing ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Notice of Non-Compliance ,
Office for Human Research Protections (OHRP) ,
Technology ,
The Common Rule
Alice C. Chang, formerly an associate professor of basic medical sciences in the College of Veterinary Medicine at Purdue University, “falsified and/or fabricated data from the same mouse models or cell lines by reusing the...more
12/28/2022
/ Audits ,
Department of Health and Human Services (HHS) ,
False Reporting ,
False Statements ,
Falsified Documents ,
Fraud ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
Medical Research ,
National Science Foundation ,
OIG ,
Probation ,
Professors ,
Research and Development ,
Research Funding ,
Restitution ,
Retracted Documents ,
Settlement Agreements ,
Universities
The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more
11/28/2022
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Exports ,
Healthcare ,
HHS Office of Research Integrity (ORI) ,
Life Sciences ,
National Institute of Health (NIH) ,
National Science Foundation ,
Research and Development ,
Scientific Research ,
The Common Rule
Two organizations representing research institutions and integrity officials have called for a virtual rewrite of the regulations that govern misconduct in Public Health Service-funded studies. The Association of Research...more
Report on Patient Privacy Volume 22, Number 11. (November 2022)
Nearly five years passed from the time the University of Texas MD Anderson Cancer Center reported to the HHS Office for Civil Rights (OCR) that three...more
11/14/2022
/ Administrative Law Judge (ALJ) ,
Civil Monetary Penalty ,
Data Breach ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Violations ,
HITECH Act ,
OCR ,
Patient Privacy Rights ,
PHI ,
Statutory Penalties
NIH is unable to “ensure grants have appropriate cybersecurity provisions” and should make nearly a half-dozen changes, according to auditors for the HHS Office of Inspector General (OIG). Yet, NIH said it had already made...more
Report on Patient Privacy 22, no. 10 (October, 2022) -
How about free?
Patients daily face the machinations of getting records from their providers, and health care practices, hospitals and even dentists struggle with...more
10/10/2022
/ Corrective Action Plans (CAPs) ,
Covered Entities ,
Dentists ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Excessive Fees ,
Health Care Providers ,
HIPAA Violations ,
Medical Records ,
OCR ,
PHI ,
Settlement Agreements