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Health Care Compliance Association (HCCA)

Understanding the requirements for waiving or altering HIPAA authorization for research

The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 10. In This Month’s E-News: October 2021

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

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

Patterson Belknap Webb & Tyler LLP

Ransomware Attacks During COVID-19

As we previously described and as reflected in the rapidly increasing number of cyber-attacks since its start, the COVID-19 pandemic has triggered a shift in working practices that hackers and other bad actors are using to...more

Professional Liability Underwriting Society (...

Technology in Healthcare

From the 2015 PLUS Medical PL Symposium session “Technology in Healthcare: EHRs & PHI,” moderator Patricia Marzella-Graubert (Swiss Re American Holdings Corporation) and panelist Alexander Grijalva (New York Presbyterian...more

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