Accréditation Sans Frontières · ASF Health Standards 9.0
Standard 17 · Digital Care and Artificial Intelligence Systems for Care
8 criteria · base standard
Base standard. 8 criteria, of which 0 non-negotiable. Each criterion is numbered 17.Y, with its classification and verification questions.
Criteria
- 17.1 Digital Care Systems Follow an Assessment and Management Process (STANDARD)
- 17.2 Digital Care Never Disadvantages a Patient Who Cannot Use It (CORE)
- 17.3 Technical Expertise Supports Digital Care Systems (STANDARD)
- 17.4 AI Systems Are Introduced in Line With Law and Best-Practice Guidance (STANDARD)
- 17.5 AI Systems Are Monitored for Unintended Consequences (STANDARD)
- 17.6 Staff Are Consulted Before an AI System Is Introduced (STANDARD)
- 17.7 Accountability for AI-Assisted Care Is Explicitly Defined (STANDARD)
- 17.8 Patients Are Informed When Their Care Involves AI (STANDARD)
17.1 Digital Care Systems Follow an Assessment and Management Process
STANDARD
Before any digital care system — telehealth platform, remote monitoring tool, patient-facing app — is introduced, the facility assesses its costs and benefits, manages its implementation, and continues to manage it afterwards — not adopted because a vendor made a compelling pitch, with no internal evaluation.
VERIFICATION QUESTIONS
- Is a cost/benefit analysis conducted before any digital care system is implemented, not adopted on vendor assurance alone?
A documented evaluation, not a decision made purely on a sales pitch. - Is interoperability between the new system and existing clinical systems assessed, with risks from non-interoperability mitigated?
Risk assessment, not an assumption that systems will simply work together. - Are potential unintended consequences of introducing the system considered before implementation, not discovered only afterwards?
Proactive consideration, not a system deployed and its effects observed only in hindsight.
17.2 Digital Care Never Disadvantages a Patient Who Cannot Use It
CORE
A process ensures that patients who cannot use digital devices, lack internet access, or are otherwise unable to engage with digital approaches are never disadvantaged by the facility's use of digital care — not digital convenience for most patients purchased at the cost of access for the patients least able to adapt.
VERIFICATION QUESTIONS
- Is there a defined alternative for patients who cannot or do not want to use a digital care approach?
An equally functional alternative, not a digital-only pathway with no fallback. - Was the introduction of a new digital care service pre-tested with representatives of patients who might struggle to use it?
Prior testing with the affected group, not an assumption that accessibility will work out. - Is there evidence that a patient unable to use digital care received equivalent, undiminished service through the alternative route?
A demonstrated instance, not a theoretical alternative that has never been tested in practice.
17.3 Technical Expertise Supports Digital Care Systems
STANDARD
The facility has access to technical expertise — in-house, vendor-provided, or contracted — to support the effective use of its digital care systems, including testing and quality checks before full implementation, not digital systems left running with no technical support behind them.
VERIFICATION QUESTIONS
- Does the facility have accessible technical expertise
in-house or contracted — for its digital care systems? — Available support, not systems left to run unsupported once installed. - Were new testing and quality checks performed before full implementation of a digital care system?
A pre-launch verification process, not a system deployed directly to patients untested. - When a digital system issue arises, is there a known route to technical support, not staff left to troubleshoot alone?
A known escalation path, not an assumption that someone will eventually sort it out.
17.4 AI Systems Are Introduced in Line With Law and Best-Practice Guidance
STANDARD
Any artificial intelligence system used to support diagnosis, triage, or care decisions is introduced and managed in accordance with applicable national or regional law and regulation or, where none exists, available best-practice guidance such as WHO's Ethics and governance of artificial intelligence for health: WHO guidance (2021) — not adopted with no reference to any external standard of responsible use.
VERIFICATION QUESTIONS
- Is any AI system in clinical use introduced in line with applicable law or regulation on AI, where this exists?
Verified compliance, not an assumption that general IT policy already covers AI-specific requirements. - Where no specific legislation exists, is the AI system's introduction informed by recognised best-practice guidance, such as WHO's Ethics and governance of artificial intelligence for health: WHO guidance (2021)?
A referenced guidance source, not an ad hoc decision with no external grounding. - Can the facility identify, when asked, the specific regulatory or guidance basis for how a given AI system is governed?
A specific answer, not a vague assurance that AI use is "handled appropriately."
17.5 AI Systems Are Monitored for Unintended Consequences
STANDARD
The facility monitors and evaluates its AI systems — auditing results for over-diagnosis or missed diagnosis, tracking patient complaints related to AI-assisted care, and checking for other unintended consequences — not deploying an AI tool and assuming it works as intended with no ongoing scrutiny.
VERIFICATION QUESTIONS
- Is the output of AI-assisted diagnosis or care decisions audited for over-diagnosis or missed diagnosis, not assumed reliable without checking?
Ongoing audit, not an assumption that AI accuracy requires no verification. - Are patient complaints or concerns related to AI-assisted care tracked and reviewed?
A specific tracking mechanism, not AI-related concerns absorbed into general feedback with no distinct visibility. - Can the facility show a recorded case where monitoring identified an issue with an AI system's performance, and a response followed?
A concrete example, not a monitoring process that has never caught anything in practice.
17.6 Staff Are Consulted Before an AI System Is Introduced
STANDARD
Staff who will deliver care using a new AI system are consulted before it is introduced, to understand the practical implications and identify training needs — not an AI tool rolled out to clinical staff with no engagement beyond a brief notification that it now exists.
VERIFICATION QUESTIONS
- Are staff who will use a new AI system consulted before its introduction, not informed only after the decision is finalised?
Prior consultation, not a rollout announcement to staff with no input sought. - Does this consultation identify practical training needs, which are then addressed before go-live?
Identified needs matched by delivered training, not a consultation that produces no follow-through. - Can staff asked directly describe having been consulted about a recent AI system introduction?
Tests whether consultation reached and registered with staff, not just whether it technically occurred.
17.7 Accountability for AI-Assisted Care Is Explicitly Defined
STANDARD
The facility has considered and documented accountability arrangements for care and treatment delivered with AI support — who is responsible when an AI-assisted decision is wrong — not leaving this as an unexamined question until the first time it matters.
VERIFICATION QUESTIONS
- Is clinical accountability for a decision made with AI support explicitly documented, not left ambiguous between clinician and system?
A clear answer, not an assumption that responsibility will sort itself out if something goes wrong. - Do clinicians using AI-supported tools understand their own accountability for the final care decision?
Demonstrated staff understanding, not a policy nobody using the tool has internalised. - Is there a defined process for reviewing accountability when an AI-assisted decision contributes to a safety incident?
A usable process, not a question left entirely open until an actual incident forces it.
17.8 Patients Are Informed When Their Care Involves AI
STANDARD
A patient whose care involves an aspect delivered with AI system support is informed of this — not left to assume every decision was made by a human clinician alone, with disclosure treated as optional rather than a standard part of informed care.
VERIFICATION QUESTIONS
- Is a patient informed when an aspect of their care involves AI system support?
Standard disclosure, not an assumption that the patient will simply figure it out or does not need to know. - Is this disclosure understandable, not buried in technical language or a general consent form a patient never reads?
A plain-language explanation a patient could act on. - Can a patient asked directly confirm they were told AI was involved in an aspect of their care?
A concrete confirmation, not disclosure that exists in policy but never reaches the patient. ————————————————————