News & Analysis as of

Health Insurance Portability and Accountability Act (HIPAA) Clinical Laboratories

King & Spalding

OIG Releases Compliance Program Guidance Applicable to All Providers and Suppliers

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On November 6, 2023, OIG released new General Compliance Program Guidance (General CPG). The General CPG applies to all individuals and entities involved in the healthcare industry. The release of the General CPG was not...more

Nelson Mullins Riley & Scarborough LLP

Clinical Research and Patient Data Protection are at a Complicated Intersection

The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more

WilmerHale

Attorneys General Bring Multistate Data Breach Settlement Against DNA Testing Lab

WilmerHale on

On February 17, 2023, the state attorneys general of Pennsylvania and Ohio reached a settlement with Ohio-based DNA Diagnostics Center (“DDC”) for a 2021 data breach that affected 2.1 million individuals nationwide and...more

McDermott Will & Emery

10 Things Providers Should Know About California’s Data Exchange Framework

McDermott Will & Emery on

By January 31, 2023, general acute care hospitals, clinical labs and certain physician organizations and medical groups in California are required to enter into the Single Data Sharing Agreement (DSA) to participate in the...more

Saul Ewing LLP

Clinical Laboratory Agrees to Pay $25,000 to Settle Potential HIPAA Security Rule Violations

Saul Ewing LLP on

On May 25, 2021, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS), announced that Peachstate Health Management, LLC d/b/a AEON Clinical Laboratories (Peachstate) agreed to pay...more

Health Care Compliance Association (HCCA)

[Event] March Research Compliance Academy - March 9th - 12th, San Diego, CA

HCCA's Health Care Research Compliance Academy is a three-and-a-half-day intensive training program focuses on compliance issues related solely to research. Its faculty is made up of experts in the field. With a wide range of...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - December 2019 #3

Robinson & Cole LLP on

It is being reported that LifeLabs, a Canadian lab company that is the largest provider of laboratory diagnostics and lab testing services in Canada, recently paid an undisclosed ransom to hackers who compromised its computer...more

McGuireWoods LLP

Highlights From The 2016 OIG Work Plan

McGuireWoods LLP on

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released its Work Plan for Fiscal Year 2016. The annual work plan can provide valuable insights into the OIG’s planned areas of...more

Davis Wright Tremaine LLP

Starting Oct. 6, Patients Can Access Test Reports Directly From Clinical Laboratories

On Oct. 6, 2014, a final rule issued jointly by the Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and Office for Civil Rights (OCR) will require all HIPAA-covered labs...more

Foley & Lardner LLP

FTC Uses Its "Unfair Acts" Power to Go After PHI Security Breach

Foley & Lardner LLP on

The Federal Trade Commission (FTC) is moving forward with an administrative action against a small medical laboratory that suffered two data security breaches, resulting in its patients’ protected health information falling...more

Obermayer Rebmann Maxwell & Hippel LLP

Lab Results on Demand: CLIA/HIPAA Amendment Increases Patient Access

A new final rule (the “Final Rule”) from the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights (collectively, the “Agencies”) gives patients and their...more

Mintz - Health Care Viewpoints

CMS Finalizes HIPAA and CLIA Amendments Intended to Increase Patient Access to Test Results

Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and...more

Mintz - Health Care Viewpoints

OMB Extends Review of Rule That Would Require Labs to Release Results to Patients

The Office of Management and Budget has extended its review of a proposed rule that would require HIPAA-covered laboratories to make test results available to patients. In our previous post on this issue way back in...more

Davis Wright Tremaine LLP

HHS Delays Require Changes to Notice of Privacy Practices for Certain Clinical Laboratories

Last week the Department of Health and Human Services (“HHS”) announced that it has postponed the Sept. 23, 2013, HIPAA Omnibus Rule deadline for many clinical laboratories to revise their notices of privacy practices...more

Davis Wright Tremaine LLP

FTC Files Complaint Against Lab Over Failed Health Information Security

In a reminder that the U.S. Department of Health and Human Services (“HHS”), with its HIPAA security requirements and enforcement authority, is not the only game in town when it comes to health information privacy, the...more

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