Report on Research Compliance Volume 20, Number 3. February 23, 2023 -
To those who say whistleblowers are only interested in the money a settlement can bring, meet Devin English. An assistant professor in the Department of...more
2/27/2023
/ Bonuses ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Fraud ,
Fraud and Abuse ,
Grants ,
Individual Accountability ,
Luxury Goods ,
National Institute of Health (NIH) ,
Settlement ,
Transparency ,
Whistleblower Awards ,
Whistleblowers
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
Report on Research Compliance Volume 20, Number 2. (January 2023)
-Hired under the Intergovernmental Personnel Act (IPA), staff referred to as IPAs assist the National Science Foundation (NSF) as temporary directors,...more
1/31/2023
/ Audits ,
Code of Conduct ,
Coronavirus/COVID-19 ,
False Advertising ,
False Reporting ,
GPS ,
Hiring & Firing ,
Investigations ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Repayment Options ,
Retirement ,
Scientific Research ,
Universities
Report on Research Compliance Volume 20, Number 2. (January 2023)
-Since his arrest in August 2019, Feng “Franklin” Tao has published 16 “research articles” for the University of Kansas (KU), authored a book and began...more
1/31/2023
/ Appeals ,
China ,
Criminal Convictions ,
Criminal Investigations ,
Deceptive Intent ,
Department of Justice (DOJ) ,
Disclosure ,
False Statements ,
National Science Foundation ,
Research and Development ,
Scientific Research ,
Termination ,
Universities
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
The university in the eastern Ukrainian city of Severodonetsk was shelled Feb. 24—the first day Russian forces invaded. The attack destroyed most of the research enterprise of Volodymyr Dahl East Ukrainian National...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
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 Research Compliance 19, no. 10 (October, 2022) -
What is a malign foreign government talent recruitment program and why does it matter?
This is a term with which research compliance officials managing federal...more
9/27/2022
/ Annual Reports ,
Disclosure Requirements ,
Educational Institutions ,
Gifts ,
National Science Foundation ,
National Security ,
New Legislation ,
OIG ,
OSTP ,
Recruitment Policies ,
Research and Development ,
Research Funding ,
Risk Assessment ,
Semiconductors ,
Training Requirements
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 Research Compliance Volume 19, Number 9 (September, 2022) -
Nina F. Schor, M.D., had been in her job as acting deputy director of NIH’s intramural research program (IRP) for 15 days when she received an email...more
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.8 (August, 2022) -
The most recent semiannual report (SAR) to Congress issued by the National Science Foundation (NSF) Office of Inspector General (OIG) details five misconduct...more
Report on Research Compliance 19, no.8 (August, 2022)
- An audit of San Francisco State University (SFSU) by the National Science Foundation (NSF) Office of Inspector General (OIG) that tested more than $1.9 million of...more
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 Research Compliance 19, no. 7 (July, 2022) -
NIH’s highest ranking external advisory committee had just heard a spirited, hour-long explanation about the agency’s Advanced Research Project Agency for Health...more
Report on Patient Privacy 22, no. 6 (June, 2022) -
Sometimes numbers tell the most compelling story. So, here are some associated with a cyberattack the University of Vermont Medical (UVM) Center suffered in October 2020...more
Report on Research Compliance 19 no. 6 (June, 2022)
- Auditors for the National Science Foundation (NSF) Office of Inspector General (OIG) questioned $35,316 of costs claimed by the University of Idaho (UI) among $42.7...more
6/2/2022
/ Audits ,
Criminal Conspiracy ,
Criminal Convictions ,
Federal Funding ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
National Science Foundation ,
OIG ,
OMB ,
Research Funding ,
Scientific Research ,
Trade Secrets ,
Universities