News & Analysis as of

Office of the Inspector General Data-Sharing

Akin Gump Strauss Hauer & Feld LLP

Research Security: New NIH Policy Requires Foreign Subrecipients to Share Lab Notebooks & Research Data With the U.S. Prime...

On September 15, 2023, the National Institutes of Health (NIH) moved forward with a controversial new policy requiring foreign subrecipients to provide, at least once per year, copies of lab notebooks, data and documentation...more

Sheppard Mullin Richter & Hampton LLP

HHS OIG Publishes Eagerly-Anticipated Federal Information Blocking Enforcement Final Rule

Industry stakeholders have been eagerly waiting for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Secretary of HHS to provide more clarity on federal information blocking...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 1. In This Month's E-News: January 2022

Report on Research Compliance 19, no. 1 (January, 2022) - Although a continuing resolution is now in place that funds the federal government through Feb. 18, committees are still working on bills that could contain...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 8. In This Month’s E-News: August 2021

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

McGuireWoods LLP

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

McGuireWoods LLP on

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more

Health Care Compliance Association (HCCA)

Compliance Perspectives: Permissible Disclosures under HIPAA, Especially in the Time of COVID-19

With the COVID-19 pandemic demands for Personal Health Information (PHI) from law enforcement, the press, politicians and the public are increasing. While there may be good reasons behind many of these demands, healthcare...more

Manatt, Phelps & Phillips, LLP

[Webinar] Re-Mapping the Fraud and Abuse Landscape: Understanding Proposed Reforms - February 13th, 1:00 pm ET

What larger healthcare goals are fueling the proposed revisions to AKS and Stark? What safe harbors and exceptions are introduced in the proposed rules? And what would the potentially transformational changes mean for...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

Ballard Spahr LLP

OIG report looks at CFPB internal sharing of complaint data

Ballard Spahr LLP on

The Office of Inspector General for the CFPB (and the Fed) recently issued a report on its evaluation of the Office of Consumer Response’s sharing of complaint data within the CFPB. ...more

K&L Gates LLP

K&L Gates Triage: Digital Health Update: ONC Information Blocking Proposal Aims to Remove Barriers to Data Sharing

K&L Gates LLP on

The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule aimed at promoting the interoperability of health information technology and enabling access to electronic...more

Bass, Berry & Sims PLC

Sprinting to Coordinated Care: Healthcare Industry Urges Stark Law Relief as OIG Solicits Feedback on Changes to the Anti-Kickback...

August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more

King & Spalding

OIG Warns Information Blocking May Affect Safe Harbor Protection

King & Spalding on

In an alert published October 6, 2015, the OIG reminded the public that “information blocking”—generally described as individuals or entities knowingly and unreasonably interfering with the exchange or use of electronic...more

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