Scott Wallask
Articles by Scott Wallask
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
Workers Use AI More than Lab Leaders Think
CEO SUMMARY: In part one of an analysis about the state of AI in clinical laboratories, The Dark Report explores how frontline workers, especially younger ones, are using AI tools like ChatGPT far more than lab leaders. Recent reports elsewhere in the business world show e…
Regional Health Systems Are New Dominant Players in M&A
READERS OF THE DARK REPORT UNDERSTAND HOW INTERTWINED THEIR CLINICAL LAB BUSINESS is with healthcare system mergers and acquisitions (M&A). Thus, financial service firm Morgan Stanley’s recent report on M&A activity in the healthcare industry will be of inte…
News Briefs on Alzheimer’s Detection
FDA-cleared IVD could replace scans There has been a significant amount of activity in recent weeks as it concerns tests to detect Alzheimer’s disease. Clinical labs and neuropathologists will want to keep a cl…
June 23, 2025, Intelligence: Late-Breaking Lab News
Clinical labs that have business in clinical trials involving genetic samples should note that on June 18, the Food and Drug Administration (FDA) ordered a review of new trials that send samples to “hostile countries for genetic engineering.” The FDA mentioned China specifically. Th…
UnitedHealth Group Heads into Difficult Waters Mid-Year
WITH THE NEWS THAT THE FORMER HEAD OF UNITEDHEALTH GROUP (UHG) has returned after the sudden resignation of the company’s CEO, it is apparent that pressure on the healthcare company continues to mount. This latest twist comes on top of a bad…
Elizabeth Holmes’ Partner Sought Campaign to Get Her Out of Jail
IN A BRIEF MENTION THAT WENT LARGELY UNNOTICED, a well-known marketing professor said he declined a request by Billy Evans—the partner of disgraced Theranos founder Elizabeth Holmes—to help organize an effort to get Holmes out of prison. “[Evans] reached out t…
June 2, 2025, Intelligence: Late-Breaking Lab News
Our sibling publication, G2 Intelligence, reported in May about a new Department of Justice (DOJ) memorandum that indicated prosecutors will seek to exercise fairness when deciding how to pursue fraud cases against clinical laboratories and other organizations. The DOJ emphasiz…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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