Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
November 2023 Labs in Court
This month’s roundup of cases includes Walgreens’ settlement with Theranos customers, kickbacks, and age discrimination.
Compliance Perspectives: When Do Cybersecurity Donations Violate Kickback Laws?
The compliance risks of giving referral sources software or equipment to ensure the security of protected health information.
Compliance Tool: Model Policy on Donating Cybersecurity Technology to Physicians
This template aims to help lab leaders develop a policy for donations of cybersecurity technology that complies with safe harbor requirements.
Digital Pathology: Regulatory and Business Considerations for Laboratories and Pathology Groups
This session will explain the digitization of the practice of pathology and the resulting business and compliance considerations of evolving digital pathology models
FDA Proposal for LDTs Risks Serious Consequences
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
FDA Watch: What Labs Need to Know About New Medical Device Cybersecurity Rules
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
Information Blocking: Simplifying the New Enforcement Rules
This session will offer an understanding of the Cures Act, as well as responsibilities and opportunities available to laboratories as a result of the law.
The Basics of Business Associate Agreements (BAAs) for Labs
When it comes to protected health information, it’s important that labs manage contracts with external sources to ensure HIPAA compliance.
Privacy in the Post Roe v. Wade World: How Could Proposed HIPAA Restrictions on Reproductive PHI Affect Labs?
Key points labs should know about the recently proposed OCR rule on privacy protections for PHI associated with reproductive health care.
