Clinical decision support AI that shows its sources
Ask a clinical question and get an answer grounded in guidelines and studies, with citations you can open and check. Arkangel AI supports the clinician's decision; it does not make it.
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Reviewed by: Arkangel AI clinical review team, Medical AI content
Clinical decision support software: what it is and how the FDA treats it
Clinicians face more guidelines, trials and drug updates than anyone can track during a visit. Clinical decision support (CDS) software brings that knowledge to the point of care: alerts and order sets in the EHR, drug-interaction checkers, risk calculators and, more recently, AI that answers clinical questions in plain language.
The problem CDS has to solve
An answer a clinician cannot verify is hard to act on. When a tool does not show why it recommends something, clinicians either ignore it or lean on it too much. Useful clinical decision support is specific to the question, current, and transparent about its sources.
FDA's four criteria for non-device CDS
Section 3060(a) of the 21st Century Cures Act (2016) added section 520(o)(1)(E) to the Federal Food, Drug, and Cosmetic Act, which excludes certain CDS software functions from the definition of a medical device. FDA's guidance "Clinical Decision Support Software" (docket FDA-2017-D-6569; current version dated January 2026, as of October 2026) explains how the agency reads the criteria. A software function is non-device CDS only if it meets all four:
- It is not intended to acquire, process or analyze a medical image, a signal from an in vitro diagnostic device, or a pattern or signal from a signal acquisition system.
- It is intended to display, analyze or print medical information about a patient or other medical information, such as peer-reviewed clinical studies and clinical practice guidelines.
- It is intended to support or provide recommendations to a health care professional about the prevention, diagnosis or treatment of a disease or condition.
- It is intended to enable that health care professional to independently review the basis for the recommendations, so that the professional does not rely primarily on them to make a clinical diagnosis or treatment decision about an individual patient.
What the criteria mean in practice
A function that fails any one criterion may be a device subject to FDA oversight: for example, software that analyzes an ECG waveform or a medical image, software meant for patients or caregivers rather than professionals, or software whose basis the clinician cannot review. Whether a specific product qualifies depends on its intended use and labeling, and the guidance gives examples on both sides of the line. This section summarizes the law; it is not legal or regulatory advice.
Where Arkangel AI fits
Arkangel AI is a medical search assistant for health professionals. It answers clinical questions with the guidelines and studies cited, so the clinician can review the basis of each answer before acting. This page makes no claim of FDA clearance or of an FDA determination for any Arkangel AI product; check your own regulatory and institutional requirements before clinical use.
How Arkangel AI supports clinical decisions
Evidence-cited answers that you review before you act.
Answers with citations
Each answer links to the guidelines and studies it draws on, so you can check the basis of a recommendation instead of trusting a summary.
Options and trade-offs, not a verdict
For diagnostic and treatment questions it lays out the guideline-supported options, their benefits and risks, and the patient factors that change the choice.
The decision stays with you
Arkangel AI organizes the evidence; the clinician reviews it, applies it to the individual patient and decides with them.
Evidence-based search built for clinicians
Ask any clinical question and get a concise, cited answer drawn from peer-reviewed literature and clinical guidelines.
Explore potential documentation gaps
Review available, supported records for potential billing details and documentation gaps. Validate findings against the complete clinical context.
Evidence at your fingertips
Explore available clinical guidelines and literature, and check the sources and relevance of each finding before applying it.
Findings for clinical review
Surface potential clinical risks and documentation gaps in supported records for professional review. Timing and coverage depend on the configured workflow.
Review potential billing gaps
Identify possible missing charges or coding gaps in supported records. Billing professionals validate the documentation and applicable payer rules before making changes.
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Book a demoFrequently asked questions
What is clinical decision support software?
Clinical decision support (CDS) software gives clinicians patient-specific information or recommendations at the point of care: EHR alerts and order sets, drug-interaction checks, risk calculators and AI assistants that answer clinical questions. It supports the clinician's judgment; it does not replace it.
How is AI used in clinical decision support?
AI clinical decision support reads a clinical question written in plain language and returns an answer drawn from guidelines and studies. Arkangel AI cites the sources behind each answer so the clinician can verify it before acting.
Is clinical decision support software regulated by the FDA?
It depends on the function. Under section 520(o)(1)(E) of the FD&C Act, added by the 21st Century Cures Act, CDS software that meets four criteria is not a medical device. Functions that analyze medical images or device signals, that are meant for patients rather than professionals, or whose basis a clinician cannot independently review may be devices. FDA's guidance "Clinical Decision Support Software" (January 2026 version, as of October 2026) explains the criteria.
What are the four criteria for non-device CDS?
All four must be met: (1) the software does not acquire, process or analyze medical images or signals from in vitro diagnostic devices or signal acquisition systems; (2) it displays, analyzes or prints medical information, such as patient information, clinical studies or guidelines; (3) it supports or provides recommendations to a health care professional about prevention, diagnosis or treatment; and (4) it lets that professional independently review the basis for the recommendations, so they do not rely primarily on them.
Does Arkangel AI replace clinical judgment?
No. It lays out the evidence and the options with their sources; the clinician reviews them and makes the decision with the patient.
Compare Arkangel AI with other clinical tools
Clinical decision support, not a replacement
Arkangel AI supports clinical decision-making and does not replace clinician judgment. Always confirm recommendations against primary sources and your local protocols before acting.