How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
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.
Enforcement Trends: Six Ways Your Lab Can Avoid HIPAA Right of Access Issues
An analysis of recent OCR enforcement actions and settlements identifies the common pitfalls labs should watch out for.
Dx Deal Roundup: Key Acquisitions for Danaher & Exact, and a Big AI Partnership
Here are what G2 Intelligence considers the three most significant deals announced in the period from late August to early September.
Compliance Perspectives: How to Ensure HIPAA Compliance among Marketing Staff
Lab leaders are at the greatest risk of HIPAA violations when they get complacent about privacy training.
Compliance Tool: Model Policy on Use of HIPAA-Protected Health Information for Marketing Purposes
This template helps lab leaders implement a written policy limiting and establishing procedures governing use of PHI for marketing.
Compliance Tool: HIPAA Compliance Fact Sheet for Lab Marketing Staff
This template helps labs create a fact sheet that highlights the key HIPAA-related do’s and don’ts for marketing staff.
Inside the Lab Industry: Q2 Earnings Decline Despite Rebound in Core Business
Though COVID-19 testing declines continue to negatively affect lab industry profits, the latest figures suggest the worst may be over.
October 2023 Labs in Court
Recent cases involve charges and judgments related to COVID-19 add-on tests, genetic testing fraud, and kickbacks.
Compliance Perspectives: How to Comply with the CMS 60-Day Overpayment Repayment Rule
While overpayments may not be your fault, they expose your lab to the risk of liability under the Affordable Care Act.
