The Bio-Startup Standard
06.02.2025

USA Issue Crossword

«Crossword Theme»
Across:
U.S. law that mandates privacy compliance for healthcare entities
U.S. agency responsible for regulating medical devices and drugs
Technology rapidly developing in healthcare, requiring risk management plans
In vitro diagnostic products designed, manufactured, and used within a single laboratory
U.S. insurance coverage affecting pricing and sales potential
Compliance required for handling medical data, especially under HIPAA
U.S. President whose policies could impact the biotech market
U.S. research institution that may see varying funding levels under different administrations
U.S. federal health insurance program for people aged 65 and older
Adherence to regulatory requirements in healthcare and biotech industries
Industry that could benefit from deregulation and domestic incentives
Considerations in the development of digital health technologies
Access pathway ensuring healthcare solutions reach patients
Essential for demonstrating the value of medical innovations
Critical aspect of business strategy in digital health
Coverage that affects market entry and sales potential in the U.S.
Type of trials and data required for market access and reimbursement
Medical products that may require FDA approval or clearance
Type of company that needs a strong marketing and communications infrastructure
A concern in clinical decisionmaking tools that hospitals must mitigate
Medical Device Reporting requirements for adverse events
Reporting requirements for corrective actions taken to address health risks
System complaint files required by the FDA for LDTs
Central focus of U.S. market access strategies
Centers for Medicare amp; Medicaid Services, involved in reimbursement decisions
European data protection regulation relevant to clinical trials
Contract Research Organization, often used for clinical trials
A startup’s first crucial sales goal in a new market
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