Assurance is the ability to answer a specific question
A medicines organisation needs to understand what it is being asked to use, which responsibilities it would carry and what evidence supports the proposed use. Assurance should make that assessment clearer.
PHARMORIS assurance work centres on the people, information and decisions involved in a defined task. The aim is a productive review with pharmacy, clinical, operational, digital and commercial colleagues, supported by evidence that matches the particular proposition.
Agree the intended use first
A tool used to organise an organisational evidence case raises different questions from a tool used to recommend treatment for an individual. The user, setting, information and consequence of the output shape the assessment.
Begin with a precise description of the task and the decisions the tool is intended to support. Identify what the organisation expects people to check and which actions remain subject to its existing authority. This allows reviewers to examine the relevant risks and evidence rather than debate an undefined promise about AI.
Give professional reviewers meaningful control
The people accountable for a medicines decision must be able to challenge the reasoning. A reviewer may require more information, reject a proposed option or identify circumstances in which a general conclusion does not apply.
Our design direction keeps qualified judgement central to the workflow. The useful assurance question is how that responsibility operates in practice: what someone sees, what they are asked to decide and how an unresolved issue reaches an appropriate person. A human name attached to a process is only useful when the work and authority are clear.
Make information traceable and appropriate
Important statements need a route back to the material supporting them. Dates, scope and source context help a reviewer distinguish a reported finding from an interpretation or a local assumption. They also make later correction more useful.
Information supplied by an organisation needs an agreed purpose and appropriate permission. A potential evaluation should establish which information is necessary, who is authorised to provide it and what handling requirements apply. Those decisions belong before information is shared. Public enquiry forms are a place to describe the problem, rather than submit patient or confidential commercial records.
Assess the complete working arrangement
An assurance discussion should consider ordinary work and exceptions. What happens when a source changes, information is missing or two accounts disagree? How would a user obtain support? When should a decision be revisited?
The organisation also needs to understand training, accessibility, operational support and the demands of introducing a different approach. These questions connect safety and usability with the commercial case. A product that is difficult to check or sustain can create work elsewhere, even when its individual output appears useful.
Know what the answer depends on.
The useful assurance question is specific: what is this output for, which evidence supports it, who reviews it and what happens when the inputs change?
Inspect a constructed decision brief through its source, assumption and open-question views. The example is designed to invite challenge; it is not a PHARMORIS assessment report.
Film source and contextAbstract optical stock movement. Not data, an instrument signal or software output.
A public decision brief | An illustrative example
Open the question.
Inspect the reasoning.
Choose a business question, then look beneath its claim. See what a public source supports, what depends on the local setting and what a useful next step could be.
A medicines or implementation team considering an AI-supported evidence review.
Would a quicker review make the decision better?
The interesting question is the complete piece of work: finding relevant material, checking it, correcting the draft and reaching an accountable decision.
A proposition to investigate
Less preparation. The same ability to challenge.
An evidence-review approach could be useful if it reduces avoidable preparation while preserving source access, relevant qualifications and professional checking. That is the proposed value to test. No time reduction, accuracy improvement or customer result is asserted in this example.
The proposition is constructed for this public brief. It is not a published finding about PHARMORIS.
What the next brief would contain
A decision someone
can commission.
- The decision
- Whether one defined review task merits an agreed evaluation.
- The comparator
- The team's existing complete review process, including checking and corrections.
- The evidence
- Representative cases, source records, reviewer decisions, complete-task effort and exceptions.
- Stop or redesign
- Stop or redesign if source checking weakens, errors are unacceptable or the complete task offers insufficient value.
Constructed public example | Not PHARMORIS-generated software output or a measured customer result.
Keep this example briefUse the relevant assessment route
In England, NHS Digital Technology Assessment Criteria provide a framework for assessing digital-health technology across clinical safety, data protection, technical security, interoperability, usability and accessibility. DTAC sits alongside other requirements; it does not replace them.
The appropriate route depends on intended use, the product and the organisation considering it. Medical-device requirements may be relevant to software with a medical purpose. An assurance discussion therefore needs to establish the applicable questions and actual evidence. Reviewers should be able to distinguish completed assessments from requirements still to be addressed for the proposed use.
NEUVIOR Data Analysis
A source.
A question.
A clearer decision.
Useful intelligence keeps its evidence attached.
Our public analysis connects a defined question with named sources, reporting periods and methods. Each source below shows the work available today and the access still needed.
Published-data analysis, research hypotheses and evidence studies are distinct kinds of work. Their meaning should remain clear as the programme grows.
NHS Business Services Authority and NHS England | Weekly
Dictionary of medicines and devices
Can the same product identity be followed consistently across sources?
Access reviewNHS England and SNOMED International | Edition-specific; UK Drug Extension every four weeks
SNOMED CT UK edition and Drug Extension
What does a concept mean in the correct edition and release?
Licence requiredNHS Business Services Authority | Monthly
BNF and SNOMED mapping
Do codes join to the correct product level and reporting month?
Source identifiedConnect the evidence to the proposed use
An assessment is most useful when it describes the proposition being examined and the information on which the reviewer can rely. Evidence from another task or an earlier evaluation may provide context without resolving the present question.
We want potential evaluators to understand what has been examined, the limits of that evidence and what the next evaluation would establish. Detailed supporting material can be discussed within an appropriately scoped engagement. The useful outcome is a clear understanding of what a next evaluation would need to establish for the organisation considering it.
Bring the assurance question that matters
Whether you lead pharmacy, clinical safety, information governance, digital services or procurement, start with the decision you need to make and the evidence your organisation expects.
A focused PHARMORIS discussion can establish the intended task, the relevant review participants and the information required to assess a possible evaluation. Clear questions create a more useful route forward for both sides.
