Health policy, systems, and equity
How Europe Funds Deep Tech: Grant Plus Equity
The EIC Accelerator can combine a project grant with an equity or quasi-equity investment, but the two components follow different decisions.
Health & Evidence Library
Health policy, systems, and equity
How access, payment, geography, language, disability, public policy, and system design shape health and care.
69 guides · Page 1 of 2
Health policy, systems, and equity
Early Health Technology Assessment Explained
Early HTA tests the potential value of a health innovation while its design, evidence plan, and investment choices can still change.
Health policy, systems, and equity
Who Uses a Clinical Algorithm Has a Nondiscrimination Duty
Section 1557 makes covered health entities responsible for identifying and mitigating discrimination risk in patient care decision-support tools.
Health policy, systems, and equity
What Orphan Drug and Rare Disease Pathways Do
Orphan designation creates development incentives for rare-disease products. It is not approval, proof of effectiveness, or automatic exclusivity.
Health policy, systems, and equity
What ICH E6(R3) Changed in Good Clinical Practice
ICH E6(R3) modernized GCP through quality by design, proportionality, clearer accountability, data governance, and support for varied trial designs.
Health policy, systems, and equity
What Health Technology Assessment Does
Health technology assessment combines clinical, economic, ethical, social, and organizational evidence to inform transparent health-system decisions.
Health policy, systems, and equity
What Good Clinical Practice Requires
Good Clinical Practice protects participants and result reliability through ethics, consent, quality by design, oversight, data integrity, and transparency.
Health policy, systems, and equity
What an EU Joint Clinical Assessment Is
An EU joint clinical assessment analyzes relative clinical effects for national HTA. It does not decide price, reimbursement, or overall added value.
Health policy, systems, and equity
Three Functions of Health Financing
Revenue raising, pooling, and purchasing determine who pays, how financial risk is shared, and which services providers deliver.
Health policy, systems, and equity
GDPR, HIPAA, and Consumer Health Data: A Practical Privacy Map
A current, practical comparison of GDPR, HIPAA, the FTC Health Breach Notification Rule, and state consumer-health privacy laws.
Health policy, systems, and equity
External Reference Pricing: A Practical Guide
External reference pricing benchmarks a medicine against prices in other countries. Its result depends on the basket, price data, formula, and review rules.
Health policy, systems, and equity
Why Usability Engineering Is a Medical Device Safety Control
How human factors work identifies critical tasks, improves interfaces, validates realistic use, and links use-related risk to FDA submissions.
Health policy, systems, and equity
Why Pilots Do Not Scale
Why a successful pilot is evidence of feasibility, not proof that an intervention will retain its effect, cost, or equity at scale.
Health policy, systems, and equity
Why a Medical Device Clinical Investigation Is Not a Drug Trial Template
How device studies adapt good clinical practice to intended use, users, procedures, configurations, deficiencies, comparators, and design changes.
Health policy, systems, and equity
When Equivalent Device Evidence Can Support an EU MDR Clinical Evaluation
A practical EU MDR guide to technical, biological, and clinical equivalence, data access, evidence gaps, and notified-body review.
Health policy, systems, and equity
What Regulatory Meetings Do Across Drug Development
FDA drug-development meetings reduce uncertainty through precise questions, complete evidence packages, and controlled follow-through.
Health policy, systems, and equity
What a Regulatory Submission Contains
A medicine regulatory submission connects administrative, quality, nonclinical, clinical, labeling, and electronic evidence into a reviewable lifecycle.
Health policy, systems, and equity
What a Plain-Language Summary Must Contain
An EU clinical-trial lay summary must identify the trial, explain its design and participants, and report benefits, harms, results, and follow-up clearly.
Health policy, systems, and equity
What a Notified Body Does
A notified body assesses whether certain medical devices meet EU conformity requirements. Learn its powers, limits, and role after certification.
Health policy, systems, and equity
The IVDR in Plain Language
A practical guide to the European Union's in vitro diagnostic regulation, including risk classes, evidence, notified bodies, and lifecycle duties.
Health policy, systems, and equity
The FDA De Novo Pathway, Explained
The FDA De Novo pathway classifies certain novel medical devices as class I or II when no suitable predicate exists and controls can manage the risks.
Health policy, systems, and equity
The Economics of Prevention: Cost-Saving Is Not the Same as Cost-Effective
Prevention can improve health without saving money. Value depends on effectiveness, costs, time horizon, baseline risk, and who pays.
Health policy, systems, and equity
The Common Rule and How IRBs Work
A plain-language guide to 45 CFR 46, human-subject research, IRB review, consent, exemptions, expedited review, and single-IRB reliance.
Health policy, systems, and equity
Software as a Medical Device After Launch: The Evidence Loop
Launch is the start of medical-device software oversight. Learn how monitoring, complaints, incidents, updates, and change control fit together.
Health policy, systems, and equity
Social Determinants of Health: The Factors Outside the Clinic
How housing, food, income, education, transportation, environment, and social context shape health and health care.
Health policy, systems, and equity
SaMD: Analytical Versus Clinical Validation
Learn how valid clinical association, analytical validation, and clinical validation support a Software as a Medical Device claim.
Health policy, systems, and equity
Risk Management Plans and Additional Risk Minimization
How EU risk management plans connect safety concerns, pharmacovigilance, routine controls, additional measures, and effectiveness evaluation.
Health policy, systems, and equity
Risk Management in Medical Software
How ISO 14971 and IEC 62304 connect hazards, requirements, software life-cycle controls, testing, cybersecurity, and postmarket learning.
Health policy, systems, and equity
Regulation as a Design Input for Medical Software
Start medical software with the intended use, claim, hazards, and evidence plan. A regulatory-first workflow turns obligations into testable specifications.
Health policy, systems, and equity
Reading FDA Adverse Event Signals: From FAERS to AEMS
What spontaneous safety reports and disproportionality analyses can show, why they cannot estimate risk, and how FDA investigates a signal.
Health policy, systems, and equity
Read a PBRER as a Traceable Benefit-Risk Decision
Understand how a PBRER integrates interval and cumulative safety, use, signals, benefits, uncertainties, and actions without delaying urgent reporting.
Health policy, systems, and equity
How the Health System Is Organized, in Plain Terms
A neutral guide to how health care is delivered, financed, coordinated, and regulated, and how a patient actually gets through it.
Health policy, systems, and equity
How Regulators Use Real-World Evidence
Real-world evidence can support product decisions when data are relevant, reliable, and analyzed for a prespecified regulatory question.
Health policy, systems, and equity
Health Literacy: Why Clear Information Changes Outcomes
How personal and organizational health literacy shape understanding, decisions, getting through the system, safety, and health outcomes.
Health policy, systems, and equity
FDA Cleared and FDA Approved Are Different Evidence Claims
The 510(k) pathway compares a device with a legally marketed predicate. Learn what substantial equivalence does and does not establish.
Health policy, systems, and equity
Building an IVD Performance Evaluation From Claim to Lifecycle Evidence
How an IVD intended purpose becomes a traceable evidence plan spanning scientific validity, analytical performance, and clinical performance.
Health policy, systems, and equity
Why a Cost-Effectiveness Threshold Is Really an Opportunity-Cost Question
A cost per QALY threshold measures health displaced elsewhere in a fixed budget, not a price for health. How NICE applies its range and why it is contested.
Health policy, systems, and equity
What Changed in FDA's 2026 Clinical Decision Support Guidance
A plain explainer of FDA's January 2026 updates to its clinical decision support and general wellness guidance, and what now sits under enforcement discretion.
Health policy, systems, and equity
The Netflix Model for Medicines: How Delinked Subscription Payment Works
How delinked subscription payment works for antibiotics, why the UK adopted it, and the market incentive it is built to correct.
Health policy, systems, and equity
The EU AI Act's Four Risk Tiers, and Why Clinical AI Usually Lands in the High-Risk Band
A plain explainer of the EU AI Act risk tiers, why most medical AI is high-risk, the core obligations that follow, and the phased timeline.
Health policy, systems, and equity
The EU AI Act Digital Omnibus: Why the High-Risk Deadlines Moved
The 2026 Digital Omnibus reset EU AI Act deadlines to December 2027 for Annex III systems and August 2028 for AI in regulated products.
Health policy, systems, and equity
The Accelerated-Approval Bargain: Surrogate Endpoints, Confirmatory Trials, and Faster Withdrawal
How FDA accelerated approval trades a surrogate endpoint for a required confirmatory trial, and how the 2022 FDORA reforms tightened that bargain.
Health policy, systems, and equity
Predicate Devices and Substantial Equivalence, Explained for Medical Software
How a device reaches market by matching a predicate, what substantial equivalence really proves, and why software strains the logic.
Health policy, systems, and equity
Paying for a Cure You Can Only Give Once: How Outcomes-Based and Annuity Agreements Work
How outcomes-based, annuity, and warranty agreements let payers cover one-time gene therapies despite uncertain long-term durability
Health policy, systems, and equity
One Set of Principles, Many Rulebooks: Harmonizing AI Medical Devices
How the 2025 IMDRF N88 document moves FDA, EU, and other regulators toward shared expectations for AI-enabled medical devices.
Health policy, systems, and equity
Managed Entry Agreements: Paying for a Drug Before the Evidence Is In
How managed entry agreements let payers cover costly new drugs before the evidence is settled, and why outcomes-based deals are so hard to monitor.
Health policy, systems, and equity
How the WHO Essential Medicines List Is Actually Chosen
An independent WHO committee meets every two years and weighs effectiveness, safety, and comparative cost to choose essential medicines.
Health policy, systems, and equity
How the WHO Classifies Digital Health, and Why a Shared Vocabulary Matters
The WHO framework sorts digital health tools by whom they serve. Here is how it works and why a common language helps evaluate technology.
Health policy, systems, and equity
How Severity Weighting Changes What a Health System Will Pay
How severity modifiers and QALY shortfall (absolute vs proportional) reset the effective price a health system pays for a treatment
Health policy, systems, and equity
How Regulators Grade Clinical Evidence, and Why the Bar Moves With Risk
Regulators weigh clinical evidence on quality, directness, and totality, then set a higher bar where the intended use and potential harm demand it.
Health policy, systems, and equity
How Post-Market Surveillance Works: Watching a Device After It Reaches Patients
A plain guide to how regulators and manufacturers keep monitoring a medical device after approval, from incident reports to periodic safety updates.
Health policy, systems, and equity
How Much Evidence Proves a Drug Works? Two Trials, One Trial, or One Plus Confirmatory Evidence
How the FDA substantial-evidence standard works, from the two-trial default and FDAMA 115 to the 2026 one-trial-plus-confirmatory-evidence shift
Health policy, systems, and equity
How ICER Builds a Value Assessment, Beyond the Price
How ICER combines an evidence-rating matrix with cost-effectiveness modeling to judge a drug's value, and what the method can and cannot settle.
Health policy, systems, and equity
How Hospitals Get Paid a Fixed Price Per Case: DRGs and Activity-Based Funding
How diagnosis-related groups pay hospitals a fixed price per case, the incentives that creates, and why several countries are now rebalancing them.
Health policy, systems, and equity
How Evidence Becomes Health Policy, and Why Good Evidence Does Not Guarantee Good Policy
How evidence travels from studies to guidelines to health policy, and why strong evidence does not automatically make sound policy.
Health policy, systems, and equity
How Clinical Guidelines Are Written
How clinical guidelines are made: who sits on the panel, how evidence is graded, how conflicts are handled, and why the advice keeps changing.
Health policy, systems, and equity
How Accountable Care Organizations Try to Pay for Health, Not Volume
A plain-language guide to how ACOs use spending benchmarks, shared savings, and downside risk, and why the benchmark math decides whether the model works.
Health policy, systems, and equity
How a QALY Is Calculated and What It Cannot Capture
How a QALY combines a utility weight and time, and the documented limits of what this single cost-effectiveness number can capture
Health policy, systems, and equity
Expanded Access Versus Right to Try: Two Doors to an Unapproved Drug
How FDA Expanded Access and the federal Right to Try pathway differ in oversight, and why neither one proves a drug is safe, effective, or even obtainable
Health policy, systems, and equity
EU MDR and Software as a Medical Device, in Plain Language
A plain guide to EU MDR, IVDR, and Software as a Medical Device: what counts as a device, how software is classified, and why the rules build clinical trust.