Report on Research Compliance 19, no. 10 (October, 2022)
- Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled...more
9/28/2022
/ 21st Century Cures Act ,
Department of Health and Human Services (HHS) ,
Falsified Documents ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Massachusetts Institutie of Technology (MIT) ,
National Institute of Health (NIH) ,
National Science Foundation ,
New Guidance ,
OSTP ,
Real World Evidence ,
Research and Development ,
Research Funding ,
Tuition
Report on Patient Privacy 22, no. 9 (September, 2022) -
When recommending best practices, federal privacy and security officials stress that organizations need to follow their protected health information (PHI) wherever...more
9/12/2022
/ Business Associates ,
Corrective Action Plans (CAPs) ,
Covered Entities ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Improper Disposal ,
OCR ,
PHI ,
Settlement Agreements
Report on Research Compliance Volume 19, Number 9 (September, 2022)
- According to the HHS Office of Research Integrity (ORI), Janina Jiang, M.D., Ph.D., a former assistant researcher in the University of California, Los...more
8/30/2022
/ Corrective Actions ,
Department of Health and Human Services (HHS) ,
HHS Office of Research Integrity (ORI) ,
Institutional Review Board (IRB) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
NIST ,
Office for Human Research Protections (OHRP) ,
OIG ,
OSTP ,
Policies and Procedures ,
Research and Development ,
Scientific Research ,
Suspensions & Debarments ,
Universities
Report on Patient Privacy 22, no. 8 (August, 2022) -
Oklahoma State University Center for Health Sciences’ (OSUCHS) breach might not have seemed all that serious at the time: No data is believed to have been misused,...more
8/16/2022
/ Breach Notification Rule ,
Corrective Action Plans (CAPs) ,
Cybersecurity ,
Data Breach ,
Data Breach Costs ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
HIPAA Violations ,
Medical Centers ,
OCR ,
Settlement Agreements
Report on Research Compliance 19, no. 7 (July, 2022)
- Given the already “heavy …burden” faced by small institutions and the National Science Foundation's (NSF) low award rate, the Council on Governmental Relations (COGR)...more
6/28/2022
/ Animal Testing ,
Audits ,
Department of Health and Human Services (HHS) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Research and Development ,
Research Funding ,
Scientific Research ,
Universities
Report on Patient Privacy 22, no. 5 (May, 2022) -
Compared to other agencies, the HHS Office for Civil Rights (OCR) is a little fish in the big federal pond, but it has an outsize effect on HIPAA covered entities (CEs) and...more
5/6/2022
/ Business Associates ,
Civil Monetary Penalty ,
Corrective Action Plans (CAPs) ,
Covered Entities ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Fines ,
Funding ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Violations ,
HITECH Act ,
Injunctive Relief ,
OCR ,
PHI ,
Popular ,
Privacy Laws
Report on Research Compliance 19, no. 5 (May, 2022) -
Nearly a decade after irregularities were first noticed in clinical trials that ultimately led to a misconduct finding and a guilty plea for embezzlement, the HHS...more
4/25/2022
/ APHIS ,
Clinical Trials ,
Corrective Action Plans (CAPs) ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Determination Letter ,
Embezzlement ,
Guilty Pleas ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
National Science Foundation ,
Noncompliance ,
Office for Human Research Protections (OHRP) ,
OIG ,
Research Funding ,
Scientific Research ,
Universities
Report on Research Compliance 19, no. 4 (April, 2022) -
A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the...more
3/28/2022
/ Cancer ,
Clinical Trials ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Determination Letter ,
Food and Drug Administration (FDA) ,
Foreign Students ,
HHS Office of Research Integrity (ORI) ,
Institutional Review Board (IRB) ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Plea Agreements ,
Research Assistants ,
Tuition ,
Universities ,
Wire Fraud
Report on Patient Privacy 21, no. 12 (December, 2021) -
Amid the letters of congratulations to new HHS Office for Civil Rights (OCR) Director Lisa Pino is a plea from the American Hospital Association (AHA): “victims” of...more
12/10/2021
/ American Hospital Association ,
Business Associates ,
Civil Monetary Penalty ,
Covered Entities ,
Cyber Attacks ,
Cybersecurity ,
Data Security ,
Department of Health and Human Services (HHS) ,
HIPAA Security Rule ,
OCR ,
Popular ,
Request For Information ,
Rulemaking Process
Report on Research Compliance 18, no. 12 (December, 2021) -
A month after rumors circulated that President Biden planned to tap former Food and Drug Administration (FDA) Commissioner Robert Califf to serve again, the...more
12/3/2021
/ Biden Administration ,
Department of Health and Human Services (HHS) ,
Electronic Reporting ,
Food and Drug Administration (FDA) ,
Medical Research ,
National Science Foundation ,
Noncompliance ,
Office for Human Research Protections (OHRP) ,
Office of Laboratory Animal Welfare (OLAW) ,
OIG ,
Presidential Nominations ,
SACHRP ,
Scientific Research
Report on Research Compliance 18, no. 12 (December, 2021) -
Washington State University’s (WSU) recent settlement with the HHS Office of Inspector General (OIG) for more than $800,000 followed a university-wide audit that...more
12/2/2021
/ Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Grants ,
OIG ,
Restitution ,
Salary Caps ,
Settlement Agreements ,
Universities
Report on Research Compliance 18, no. 11 (November, 2021) -
A professor in the University of Washington (UW) College of Engineering allegedly falsified award documents submitted to the National Science Foundation (NSF)...more
11/1/2021
/ Audits ,
Coronavirus/COVID-19 ,
DATA Act ,
Department of Health and Human Services (HHS) ,
Environmental Protection Agency (EPA) ,
Espionage ,
False Claims Act (FCA) ,
False Statements ,
Falsified Documents ,
Fraud ,
Guilty Pleas ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
National Science Foundation ,
OIG ,
OMB ,
Probation ,
Professors ,
Research and Development ,
Research Funding ,
Restitution ,
Settlement Agreements ,
Tenure ,
Universities
Report on Research Compliance 18, no. 10 (October, 2021) -
An audit by the HHS Office of Inspector General (OIG) of the National Human Genome Research Institute’s (NHGRI) pre-award risk assessment process concluded that...more
9/28/2021
/ Audits ,
Clinical Trials ,
Compliance ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Statements ,
Form 990 ,
Grants ,
Guilty Pleas ,
Health Care Providers ,
Indictments ,
Institutional Review Board (IRB) ,
IRS ,
Mail Fraud ,
Massachusetts Institutie of Technology (MIT) ,
Medical Records ,
Medical Research ,
Money Laundering ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
OIG ,
Plea Agreements ,
Policies and Procedures ,
Research Funding ,
Restitution ,
Risk Assessment ,
Sexual Harassment ,
Third-Party Risk ,
Wire Fraud
Report on Research Compliance 18, no. 9 (September, 2021) -
A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more
8/30/2021
/ Animal Testing ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Draft Guidance ,
False Claims Act (FCA) ,
Federal Funding ,
Federal Grants ,
Hackers ,
HHS Office of Research Integrity (ORI) ,
Hospitals ,
Indictments ,
Malware ,
Medical Research ,
Medical School ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office of Laboratory Animal Welfare (OLAW) ,
OIG ,
OMB ,
Phishing Scams ,
Public Comment ,
Research and Development ,
Research Funding ,
Scientific Research ,
Universities ,
Voluntary Disclosure
Issue a final rule revising the privacy regulation and write guidance on the information blocking rule. Formalize the fledgling audit program required by Congress more than 10 years ago. Engage with providers and other...more
8/13/2021
/ 21st Century Cures Act ,
Audits ,
Biden Administration ,
Business Associates ,
Covered Entities ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HIPAA Violations ,
Information Blocking Rules ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Ransomware
Report on Research Compliance 18, no. 8 (August, 2021) -
“As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more
7/26/2021
/ Audits ,
Best Practices ,
Clinical Trials ,
Compliance ,
Consent ,
Data Privacy ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Research Funding ,
The Common Rule ,
Universities
Report on Patient Privacy 21, no. 7 (July, 2021) -
...These heartfelt comments are among those submitted to the HHS Office for Civil Rights (OCR) in response to its January notice of proposed rulemaking (NPRM), which...more
7/9/2021
/ Caregivers ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Mental Health ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
PHI ,
Physicians ,
Public Comment ,
Substance Abuse
Report on Research Compliance 18, no. 7 (July 2021) -
In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
6/28/2021
/ Auditors ,
Clinical Trials ,
Compliance ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Data Rights ,
Data Sets ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Failure To Disclose ,
False Statements ,
FBI ,
Food and Drug Administration (FDA) ,
Foreign Investment ,
Funding ,
Guilty Pleas ,
Hospitals ,
Medical Records ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
OMB ,
Pharmaceutical Industry ,
Plea Agreements ,
Research and Development ,
Scientific Research ,
Universities
Report on Research Compliance 18, no. 6 (June 2021) -
Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more
5/24/2021
/ Compliance ,
Criminal Conspiracy ,
Data Transfers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Environmental Protection Agency (EPA) ,
FDA Warning Letters ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Health Care Providers ,
HHS Office of Research Integrity (ORI) ,
Hospitals ,
National Institute of Health (NIH) ,
National Science Foundation ,
Noncompliance ,
OIG ,
OSTP ,
Pharmaceutical Industry ,
Reporting Requirements ,
Restitution ,
Scientific Research ,
Trade Secrets ,
Universities
Report on Research Compliance 18, no. 6 (June 2021) -
Nearly four years after noticing spending “irregularities” by a principal investigator (PI), the University of Nevada Las Vegas (UNLV) entered into a settlement...more
5/21/2021
/ Civil Monetary Penalty ,
Conflicts of Interest ,
Department of Health and Human Services (HHS) ,
FCOI ,
Fringe Benefits ,
HRSA ,
National Institute of Health (NIH) ,
OIG ,
Risk Assessment ,
Self-Disclosure Requirements ,
Settlement Agreements
Report on Patient Privacy 21, no. 5 (May 2021) -
Given the hundreds of thousands of HIPAA covered entities (CEs) and business associates (BAs) and the two dozen or so enforcement actions the HHS Office for Civil Rights...more
5/7/2021
/ Business Associates ,
Cooperation ,
Covered Entities ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Failure to Notify ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Investigations ,
OCR ,
PHI ,
Popular
Report on Research Compliance 18, no. 5 (May 2021) -
For the first time since 2012, the HHS Office of Research Integrity (ORI) issued an annual report, but for those used to previous updates or looking for useful details,...more
Report on Research Compliance 18, no. 4 (April 2021) -
A new report by the National Academies of Sciences, Engineering, and Medicine examining the impact of the COVID-19 pandemic found “intensified complications related...more
3/30/2021
/ Conflicts of Interest ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
HRSA ,
JCORE ,
Medical Research ,
National Institute of Health (NIH) ,
National Security ,
Office for Human Research Protections (OHRP) ,
OIG ,
Presidential Memorandum ,
Research Funding ,
Scientific Research ,
Universities
Report on Patient Privacy 21, no. 3 (March 2021) -
Sometime during the fall, a worker for a subcontractor of Humana Inc. decided to share actual member information from medical records via a Google document with people he...more
3/25/2021
/ Business Associates ,
Business Associates Agreement (BAA) ,
Compliance ,
Covered Entities ,
Data Breach ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Records ,
Notice Requirements ,
OCR ,
Patient Privacy Rights ,
PHI ,
Subcontractors
Report on Patient Privacy 21, no. 2 (February 2021) -
Unless an extension is granted or the notice of proposed rulemaking (NPRM) is withdrawn, covered entities (CEs) and business associates (BAs) have until late March to...more
2/26/2021
/ Business Associates ,
Comment Period ,
Covered Entities ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
HIPAA Privacy Rule ,
HIPAA Violations ,
Medical Records ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Right of Access ,
Settlement Agreements