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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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 Aims to Address Growing Cybersecurity Threats to Medical Devices
The agency recently issued draft guidance to medical device manufacturers to help protect their products from cyberattacks.
First G2 Webinar Since LMG Takeover Sees Lively Q&A Session
April 27 webinar featuring an update on the brand and talk on recent lab industry developments sees strong engagement.
Protect Your Lab against HIPAA Right of Access Liability Risks
Key points to educate your staff on when it comes to patient requests for test records and other protected health information.
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
In this month’s key cases, Myriad Genetics shells out, Illumina wins a decisive victory, a whistleblower suit is tossed, and false billing of UDTs costs a lab at least $11.6 million.
A Model Script to Help Avoid HIPAA Right of Access Violations
This script helps prepare frontline staff to answer questions that patients seeking access to their PHI are likely to ask.
Who’s Allowed to Bill for Laboratory Reference Testing?
An overview of the rules and requirements to help you keep your reference laboratory billing arrangements compliant.
Lowering the Boom on COVID-19 Relief Scammers
The DOJ recently charged 21 defendants across the US for allegedly carrying out COVID-19 scams worth just under $150 million.
Upcoding Accusations Cost Pathology Practice $2.4 Million
Recent case highlights importance of having an actual written analysis in your records justifying use of a certain code.
White House Asks Congress to Get Moving on COVID-19 Relief Funding
The Biden administration released another statement on Wednesday reminding lawmakers of the consequences of not resolving the issue quickly.
Non-COVID Products Help Drive QIAGEN Q1 2022 Growth
Assay tech company shares that its Q1 2022 results were better than expected in spite of declines in COVID-19 product sales.