Report on Research Compliance 18, no. 3 (March 2021) -
◆ A former post-doctoral fellow at the McGovern Medical School, part of the University of Texas (UT) Health Science Center, admitted to committing research misconduct...more
2/24/2021
/ Audits ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
False Statements ,
Guilty Pleas ,
HHS Office of Research Integrity (ORI) ,
Hospitals ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Scientific Research ,
Universities ,
Wire Fraud
Report on Research Compliance 18, no. 1 (January 2021) -
The National Science Foundation (NSF) will be accepting comments on a revised version of its Proposal & Award Policies & Procedures Guide (PAPPG) expected to be...more
12/30/2020
/ Colleges ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
False Statements ,
GAO ,
Grants ,
Guilty Pleas ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Professors ,
Regulatory Requirements ,
Research Funding ,
Scientific Research ,
Universities
Report on Research Compliance 17, no. 12 (December 2020) -
Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
11/25/2020
/ Clinical Trials ,
Comment Period ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Communications ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Health Care Providers ,
Health Technology ,
HHS Office of Research Integrity (ORI) ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Intent to Defraud ,
Medical Records ,
Medical Research ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
Office of Laboratory Animal Welfare (OLAW) ,
Pediatrics ,
Pharmaceutical Industry ,
Physicians ,
Public Comment ,
Public Health ,
Research and Development ,
Telehealth ,
Veterinarians ,
Wire Fraud
Report on Research Compliance 17, no. 11 (November 2020)
- In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board...more
10/24/2020
/ AAMC ,
Biomedical Companies ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Criminal Convictions ,
Cybersecurity ,
Data Management ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Funding ,
Fraud ,
Institutional Review Board (IRB) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
Professors ,
Public Health Emergency ,
Scientific Research ,
Universities
Report on Patient Privacy 20, no. 10 (October 2020) -
September was quite the month for enforcement actions by the HHS Office for Civil Rights (OCR). The agency announced eight settlements totaling more than $10 million....more
10/16/2020
/ Business Associates ,
Compliance ,
Corrective Action Plans (CAPs) ,
Covered Entities ,
Data Breach ,
De-Identified Protected Health Information ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Hackers ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Settlement
Report on Research Compliance 17, no. 10 (September 24, 2020) -
Although full implementation is several years away, leaders of research institutions and organizations representing them are asking the Department of Defense...more
Report on Research Compliance 17, no. 6 (June 2020) -
With the recent appointment of an HHS leader as its permanent director and a former Johns Hopkins misconduct official to another key post, the HHS Office of Research...more
5/22/2020
/ Academic Misconduct ,
Administrative Appointments ,
Compliance ,
Department of Health and Human Services (HHS) ,
Electronically Stored Information ,
Federal Grants ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
Regulatory Oversight ,
Request For Information ,
Research and Development ,
Scientific Research ,
Sequestration
Report on Research Compliance 17, no. 5 (May 2020)
- Cybercriminals are “sending malicious phishing emails that appear to be from trusted federal agencies,” such as HHS, in order to “steal sensitive data,” warned Michael...more
4/29/2020
/ Academic Misconduct ,
Allowable Expenses ,
Collusion ,
Compliance ,
Cyber Crimes ,
Department of Health and Human Services (HHS) ,
Electronically Stored Information ,
Evidence ,
Foreign Affiliates ,
Government Investigations ,
HHS Office of Research Integrity (ORI) ,
Internal Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
OIG ,
Peer Review ,
Phishing Scams ,
Repayment Options ,
Termination ,
University Studies
Report on Research Compliance 17, no. 4 (April 2020)
The Food and Drug Administration has accused a University of Michigan physician and professor of conducting research for more than three years after his approval from the...more
4/1/2020
/ Audits ,
Clinical Trials ,
Compliance ,
Conflicts of Interest ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Grants ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
NASA ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
Professors ,
Reporting Requirements ,
Sexual Harassment ,
Warning Letters ,
Wrongful Termination
Report on Patient Privacy 20, no. 3 (March 2020) -
A gastroenterologist in Utah who felt he was being held captive by an electronic health record (EHR) vendor found his 2013 complaint to the HHS Office for Civil Rights...more
Report on Patient Privacy 20, no. 2 (February 2020) -
The year is still young, but the federal government has announced a potentially far-reaching privacy effort that should catch HIPAA compliance officers’ attention. And...more
2/12/2020
/ Cybersecurity ,
Department of Health and Human Services (HHS) ,
EHR ,
Health Insurance Portability and Accountability Act (HIPAA) ,
NIST ,
OCR ,
OMB ,
ONC ,
Patient Access ,
Patient Privacy Rights ,
Public Comment
Report on Patient Privacy 20, no. 1 (January 2020) -
In the waning days of 2019, the HHS Office for Civil Rights (OCR) didn’t halt the HIPAA enforcement momentum it had built up during the last quarter of the year, dinging...more
1/13/2020
/ Ambulance Providers ,
Business Associates ,
Compliance ,
Corrective Action Plans (CAPs) ,
Corrective Actions ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Encryption ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HIPAA Security Rule ,
OCR ,
PHI ,
Security Risk Assessments ,
Settlement
Report on Research Compliance 17, no. 1 (January 2020) -
? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more
12/20/2019
/ Clinical Trials ,
Criminal Conspiracy ,
Criminal Convictions ,
DATA Act ,
Department of Health and Human Services (HHS) ,
Diversity ,
Drug & Alcohol Abuse ,
Ethics ,
FCOI ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Fraud ,
GAO ,
Healthcare Fraud ,
Institutional Review Board (IRB) ,
IRB ,
JCORE ,
Medical Research ,
National Institute of Health (NIH) ,
NIAAA ,
NIDA ,
Office for Human Research Protections (OHRP) ,
OMB ,
Opioid ,
OSTP ,
Public Citizen ,
Public Comment ,
Request For Information ,
Sexual Harassment ,
USAspending.gov
Report on Research Compliance 17, no. 1 (January 2020) -
Ah, those pesky residents. If you’re a teaching hospital, you can’t live without them, right? But sometimes living with them is mighty costly, as the University of...more
12/19/2019
/ Administrative Appeals ,
Civil Monetary Penalty ,
Covered Entities ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Encryption ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Violations ,
Laptop Computers ,
Medical Research ,
Medical Residents ,
OCR ,
PHI ,
Settlement ,
Teaching Hospitals
Report on Patient Privacy 19, no. 12 (December 2019) -
Sentara Hospitals, a nonprofit group of 12 medical centers in Virginia and North Carolina, will implement a fairly minimal two-year corrective action plan (CAP) and...more
12/5/2019
/ Billing ,
Billing Errors ,
Business Associates ,
Business Associates Agreement (BAA) ,
Civil Monetary Penalty ,
Compliance ,
Corrective Actions ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Violations ,
HIPAA Breach ,
Hospitals ,
Inadvertent Disclosure ,
Medical Records ,
OCR ,
Patient Privacy Rights ,
PHI ,
Reporting Requirements ,
Settlement