Standards › Standard 2D › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · DIG-SOP-002 · Version 1.1 · Approved by the ASF Expert Committee
Supports: 2D.1
At a glance
- Assess every digital care system before it is introduced: costs, benefits, interoperability and possible unintended effects.
- Record the assessment on DIG-FRM-002, signed by the clinical and IT leads.
- Do not adopt a system on vendor claims alone.
- Review each system after go-live and at least yearly.
- Stop and get help straight away if: a system is in clinical use with no completed assessment.
1. Purpose
To make sure every digital care system (telehealth, remote monitoring, patient-facing app, clinical software) is assessed, implemented and managed through a defined process, not adopted on a vendor pitch [EC].
2. Scope
| Applies to | Clinical leads, IT lead, procurement lead, chief executive |
| Locations | All clinical and patient-facing digital systems at the facility |
| When | Before introduction, at go-live, and yearly |
| Does not apply to | Standard office software with no clinical use (covered by IT policy DIG-POL-001) |
3. Definitions
| Term | Meaning |
|---|---|
| Digital care system | Any software or device that supports diagnosis, treatment, monitoring or communication with patients |
| Interoperability | The ability of two systems to exchange and use data correctly |
| Unintended consequence | An effect not planned, such as extra workload, duplicate records or missed alerts |
4. Background
Digital tools can improve care but also create new risks: extra workload, data errors, failed links between systems and missed alerts. Criterion 2D.1 asks for an internal assessment and management, not reliance on a vendor’s claims.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Chief executive | Approves systems with a major clinical impact | Executive |
| Clinical lead for the area | Defines the clinical need; signs the assessment | Clinical |
| IT lead | Assesses interoperability and security | Health informatics (EC) |
| Procurement lead | Collects vendor information; keeps the contract | Procurement |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Digital tool assessment template (DIG-FRM-002) | Current | Available to project leads |
| Vendor information and evidence | From the vendor, dated | On file |
7. Safety
- No clinical system goes live without a tested interface to the systems it depends on.
- Patient data handling must meet the information security policy (DIG-POL-001).
8. Before you start
- Confirm the clinical need in writing before any vendor evaluation.
9. Procedure
Step 1. Define the need.
- Write the clinical problem the system will solve, the patients affected, and how success will be measured.
Key point: A system without a stated problem will be hard to evaluate later.
Step 2. Assess costs and benefits.
- Estimate costs: purchase, training, support, interfaces, and staff time.
- Estimate benefits and how they will be measured.
- Record the comparison on DIG-FRM-002.
Key point: Cost and benefit must be compared with real figures, not the vendor brochure.
Step 3. Assess interoperability.
- List every system the new tool must exchange data with.
- Test each link in a non-live environment.
- Record each risk from non-interoperability and its mitigation.
Key point: Two systems that do not talk create the most common data errors.
Step 4. Assess unintended consequences.
- Ask the clinical lead and two front-line staff what could go wrong: extra workload, duplication, alert fatigue, data errors or delay.
- Record each possible effect and how it will be prevented or checked.
Key point: Ask the people who will use it, not only the people who buy it.
Step 5. Decide and manage implementation.
- The approver decides on the basis of the record.
- Manage go-live with a named owner, training, a fall-back plan and a support route.
Key point: A fall-back plan is needed before go-live, not after the first failure.
Step 6. Review.
- Review the system after three months of use, and yearly after that.
- Record the findings and actions.
Key point: Systems change, and so do the risks.
10. Decision points
- If the assessment shows a high clinical risk that cannot be mitigated, the system is not introduced until the chief executive decides otherwise, with reasons recorded.
11. Special situations
| Situation | Action |
|---|---|
| Urgent need (for example, during an outbreak) | Use a temporary, reviewed approval with a time limit set by the chief executive, then complete the assessment. |
12. Escalation
- System failures affecting patients go to the chief executive and INC-POL-001 at once.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Systems in clinical use with completed assessment | 100% | Yearly | IT lead | Stop use until assessed |
| Post-implementation reviews done at 3 months | 100% | Each system | Clinical lead | Escalate to chief executive |
| Interface failures logged and reviewed | 100% | Quarterly | IT lead | Escalate |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| DIG-FRM-002 Digital Tool Assessment | IT governance file | the period set by the facility’s records policy years after the system is retired |
15. Training
- Project leads are trained in the assessment method at appointment (EC).
16. Related documents
| ID | Title | Use |
|---|---|---|
| DIG-FRM-002 | Digital Tool Assessment Template | Used in steps 2 to 4 |
| DIG-POL-001 | Information Security and Access Control Policy | Security rules |
| DIG-FRM-004 | Digital System Test and Support Record | Test records |
17. Evidence
| Reference | Note |
|---|---|
| E-006 | ASF Policy Framework v1.2. Adapted. |
| E-009 | ASF Expert Committee consensus. Assessment thresholds to be set by the committee. |
18. Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | First version | Approved by the ASF Expert Committee |
| 1.1 | the date of approval | Internal quality review: corrected cross-references, status wording and document control | Approved by the ASF Expert Committee |
E-learning for this document
Planned course: Digital care assessment and management process. New course planned.
References
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)
- Accréditation Sans Frontières (2026). ASF Policy Framework v1.2. (E-006)