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AI Tools for Health Law Attorneys
AI tools that help health law attorneys research HIPAA rules, find healthcare case law, review clinical trials, and advise on compliance.
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11th Cir. (2024)
OCR settlement upheld — $875K · unauthorized employee access · snooping
9th Cir. (2023)
Business associate liability — vendor breach extends to covered entity
4th Cir. (2023)
Minimum necessary standard — EHR vendor access scope disputed
Trend
Courts increasingly imposing vicarious liability on covered entities for BA failures
Average OCR Settlement
$1.2M per action · 2022–2024
Healthcare regulation and compliance research
Research HIPAA, Stark Law, Anti-Kickback Statute, CMS regulations, and state healthcare laws. Stay current on regulatory guidance, OCR enforcement trends, and recent DOJ settlements affecting healthcare clients.
What are the current HHS-OIG exclusion screening requirements for healthcare providers? How often must providers screen employees and contractors against the OIG exclusion list?
OIG requires monthly screening of all employees and contractors against the LEIE. Joint Commission standards recommend pre-hire and monthly thereafter. Failure to screen can result in repayment of Medicare/Medicaid claims — CMS has imposed penalties up to $10K per violation per day. Three recent settlements reviewed.
ToolRouter research
Screening Frequency
Monthly screening of all employees and contractors required
Joint Commission
Pre-hire AND monthly ongoing screening recommended
Failure to Screen
Medicare/Medicaid repayment required · up to $10K/violation/day
Recent Settlements
3 settlements reviewed · average CMP $2.3M
Case law research for healthcare disputes
Search federal and state court decisions on healthcare contract disputes, HIPAA litigation, False Claims Act cases, and medical staff privileges. Find controlling precedent for your jurisdiction.
Find False Claims Act qui tam case decisions from the last 4 years involving upcoding by hospital systems. What relator disclosure requirements have courts focused on?
Found 12 relevant decisions. Key trend: courts scrutinizing original source requirement more strictly post-Schutte v. SuperValu (SCOTUS 2023). Two circuit splits on upcoding intent standard. Relators now must show subjective vs. objective scienter — significant impact on qui tam strategy.
ToolRouter search_cases
Key Trend
Courts scrutinizing original source requirement more strictly post-Schutte (SCOTUS 2023)
Circuit Split
Subjective vs. objective scienter standard for upcoding intent — 2 circuits divided
Relator Impact
Must now demonstrate subjective scienter — significant strategy implication
Decisions Found
12 relevant FCA upcoding decisions identified
FDA drug and device regulatory research
Look up FDA approval status, prescribing information, warning letters, and recall history for drugs and medical devices. Support product liability defense, regulatory compliance advice, and clinical trial work.
Look up the complete FDA prescribing information for Humira (adalimumab) — indications, black box warnings, post-market safety data, and any biosimilar competition that has affected the labeling.
Humira full prescribing information retrieved. Black box warnings: serious infections (TB, opportunistic), malignancies (lymphoma, other cancers). Post-market: 14 label updates since initial approval. Current biosimilars: 7 approved (Hadlima, Hyrimoz, etc.) — no labeling changes triggered by biosimilar entry.
ToolRouter lookup_drug
Approved Indications
RA · PsA · AS · Crohn's · UC · PS · HS · JIA · uveitis
Black Box Warning
Serious infections (TB · opportunistic) · malignancies (lymphoma)
Post-Market
14 label updates since initial approval · 7 biosimilars approved
Biosimilar Impact
No labeling changes triggered by biosimilar entry
Clinical trial compliance and research
Search ClinicalTrials.gov to research active, completed, and terminated trials for specific drugs, devices, or sponsors. Support clients in clinical trial agreement negotiations and regulatory compliance.
Find all clinical trials sponsored by a major pharma client studying CAR-T cell therapies for B-cell malignancies. Show protocol status, phase, and whether any trials were terminated early.
Found 8 trials matching criteria. 5 active (Phase I-III), 2 completed, 1 terminated early (safety signal — Grade 3 CRS events exceeded protocol threshold). The terminated trial (NCT04912345) includes a full safety report. Early termination report filed with FDA within 15 days per 21 CFR 312.32.
ToolRouter search_trials
Phase I-III Active
5 trials recruiting · NCT04810193 · 04887415 · 05031468 · 05234528 · 05887321
Completed
2 trials — final study reports filed with FDA
Terminated (NCT04912345)
Safety signal — Grade 3 CRS events exceeded protocol threshold
Regulatory Compliance
Early termination report filed within 15 days per 21 CFR 312.32
Healthcare company due diligence
Research healthcare companies for corporate structure, regulatory compliance history, and prior government investigations. Essential for M&A due diligence, joint ventures, and healthcare transaction advisory.
Research MedGroup Solutions LLC for M&A due diligence. I need corporate registration, any OIG or CMS exclusion history, prior DOJ or HHS settlements, and any False Claims Act cases.
MedGroup Solutions LLC: Delaware entity (2016), active. No current OIG exclusion. Prior settlement: DOJ $2.1M settlement (2021) for billing Medicare for services not rendered — Corporate Integrity Agreement in place until 2026. CIA compliance monitoring ongoing. Flag for buyer: CIA terms survive change of control.
ToolRouter lookup_company
Entity Status
Delaware LLC · registered 2016 · active
OIG Exclusion
No current exclusion in LEIE
DOJ Settlement (2021)
$2.1M — billing Medicare for services not rendered
CIA Status
Corporate Integrity Agreement in place until 2026 · monitoring ongoing
Buyer Flag
CIA terms survive change of control — buyer inherits obligations
Product recalls and patient safety research
Search FDA and CPSC product recall databases to support product liability cases, regulatory advice, and healthcare client risk management. Identify patterns in device failures and regulatory responses.
Search FDA medical device recalls from the last 2 years for insulin pumps with Class I recall designations. Include the device name, manufacturer, defect description, and number of units recalled.
Found 4 Class I insulin pump recalls. Most significant: Medtronic MiniMed (2024) — 326,000 units recalled due to over-delivery risk from faulty reservoir threading. FDA required immediate patient notification and replacement. Three prior incidents with same design documented in MAUDE database.
ToolRouter search_recalls
Medtronic MiniMed (2024)
326,000 units · over-delivery risk from faulty reservoir threading
Tandem Diabetes (2024)
18,500 units · software error causing inaccurate bolus calculation
Insulet OmniPod (2023)
44,000 units · adhesive failure — pod detachment risk
MAUDE Database
Medtronic: 3 prior incidents with same design documented
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HIPAA enforcement research
Research HHS OCR HIPAA enforcement actions and settlements from the last 3 years. What are the most common violations cited, average settlement amounts, and any new areas of enforcement focus?
False Claims Act cases
Find False Claims Act cases involving home health agencies from the last 5 years. Show the alleged violation, amount recovered, and any key rulings on scienter or original source doctrine.
Drug regulatory history
Look up the complete regulatory history for Jardiance (empagliflozin): initial approval, all subsequent label changes, black box warnings, post-market safety data, and any pending FDA reviews.
Clinical trial search
Find all Phase III clinical trials for a specific biologic drug. Include trial sponsors, enrollment status, primary endpoints, and any Safety Monitoring Committee holds in the last 12 months.
Healthcare M&A due diligence
Research Apex Medical Group for M&A due diligence. Check corporate registration, any OIG exclusion history, prior government settlements, state medical board actions, and current CIA status.
Device recall research
Search FDA Class I and Class II medical device recalls for orthopedic implants from the last 3 years. Include manufacturer, device type, defect description, units recalled, and regulatory response.
Telehealth regulation research
Research the current federal regulatory framework for telehealth prescribing controlled substances post-COVID. Which DEA waivers expired, which were extended, and what are the current Ryan Haight Act requirements?
State health law research
Research California's Confidentiality of Medical Information Act (CMIA) compared to HIPAA. Where does CMIA provide stronger protections, and how does it apply to digital health apps?
Tools to power your best work
Deep ResearchAI research reports with citations
Drug InformationDrug info: recalls & side effects
Product RecallsFood, drug, and product recalls
Regulatory ActionsSEC, CFPB, FDIC & Federal Register
Company LookupCompany data for UK, US & EU
Compliance ScreeningAML, sanctions, PEP & due diligence investigations
Clinical TrialsClinical trials & drug safety data
Legal ResearchCase law, statutes, regulations & legislation worldwide
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Regulatory compliance audit research
Before advising a healthcare client on compliance, research the current regulatory landscape and recent enforcement actions in their specific area.
Healthcare M&A due diligence
Run a comprehensive regulatory and compliance due diligence on a healthcare acquisition target.
Frequently Asked Questions
Does the legal research tool cover administrative law and agency decisions, not just court cases?
Legal Research covers published federal and state court decisions. For administrative agency decisions (HHS ALJ rulings, CMS coverage determinations, OIG advisory opinions), use Deep Research which searches across government websites and published agency databases.
How does the clinical trials tool handle terminated trials and safety holds?
Clinical Trials searches the full ClinicalTrials.gov database including terminated, withdrawn, and suspended trials. Safety holds (clinical holds under 21 CFR 312.42) and protocol amendments are shown where they have been registered. Early termination reasons are included when disclosed.
Can the drug information tool help with off-label promotion compliance analysis?
Drug Information returns the complete FDA-approved prescribing information and labeling. Comparing the approved indications against a company's actual promotional materials is a key use case for off-label promotion compliance work. The tool shows the full regulatory history of label changes.
How useful is this for Stark Law and Anti-Kickback Statute compliance research?
Deep Research and Legal Research together cover AKS and Stark Law extensively. Deep Research surfaces OIG advisory opinions, safe harbor regulations, and agency guidance. Case Law finds court decisions interpreting the statutes. Regulatory Actions finds relevant DOJ and OIG enforcement cases.
Can I use product recall research to support False Claims Act or product liability cases?
Yes. Product Recalls searches FDA Class I, II, and III device recalls and drug recalls with defect descriptions and units affected. This data supports identifying recall patterns, documenting prior notice to manufacturers, and finding evidence relevant to both government enforcement and private litigation.
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