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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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
FDA’s Breakthrough Designation Now Includes Health Equity Provision
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
Building a Home for Health Equity
The laboratory’s role in reaching underserved patient populations: an interview with Richard Levenson, Keisuke Nakagawa, and Michele Mitchell
Bringing the Lab to the Patients
Actions clinical laboratories can take to better reach underserved communities, raise the lab’s profile, and increase health equity for all
Removing Racial Inequalities in Lab Referrals
Clinical laboratory professionals must consider how race affects test referrals and what they can do to combat existing inequities
Diversity, Equity, and Inclusion: Beyond the Checklist
Working toward greater equity and access to careers in the clinical lab
The Benefits of Group A Streptococcus NAAT
Labs that invested heavily in POC molecular tests during COVID-19 are well positioned to leverage this equipment toward GAS diagnostics
May 2024 Labs in Court
Recent enforcement actions and court cases include kickback schemes a-plenty and a reminder to focus on HIPAA compliance
Choosing and Using the Right Compliance Solution
Factors laboratories should consider when evaluating their compliance challenges, needs, and goals to select compliance solutions
Increasing Fees, Decreasing Access to Data in New CMS Proposal
New policies aim to better protect data against increasing cyberattacks, but academics say the changes will limit critical research
The Landscape of Laboratory Corruption
How widespread is corruption in the lab—and what can be done to combat it?