Summary
Regulation 11 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 says care and treatment must only be provided with the consent of the relevant person, and where somebody aged 16 or over lacks capacity the registered person must act in accordance with the Mental Capacity Act 2005. Nothing in it mentions a form. What a system has to evidence is therefore harder than a stored signature. What was explained, which risks and alternatives were covered, who explained them, when that happened relative to the procedure, and where capacity was in question, that it was assessed. A signed PDF in a document store proves a form was signed and almost nothing else.
Consent is the question where the gap between a document and a record is widest. Almost every clinic can produce a signed form. Far fewer can produce an account of the conversation the form was supposed to summarise.
Regulation 11 is three sentences long and asks only that care is provided with consent. The weight sits in what consent means, and since 2015 that has been settled by the courts rather than by the regulation.
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See it in your clinicWhat was explained, by whom, and when, on the same record as the procedure it was explaining.
Request a demo| Fact | Why it is asked for | Where systems fall short |
|---|---|---|
| What was explained | Consent is to a specific treatment with specific risks, not to a document | The form lists risks generically and the record does not say which were discussed |
| Who explained it | The person taking consent must understand what they are describing | A signature field for the patient and none for the clinician |
| When it happened | Consent given minutes before a procedure is a different fact from consent given with time to consider | One timestamp, written when the form was uploaded rather than when the discussion happened |
| Whether capacity was in question | Regulation 11 points to the Mental Capacity Act 2005 where somebody aged 16 or over cannot consent | No field exists, so an assessment that happened leaves no trace |
What Regulation 11 actually requires
Regulation 11 states that care and treatment of service users must only be provided with the consent of the relevant person. Where the service user is 16 or over and unable to consent because they lack capacity, the registered person must act in accordance with the Mental Capacity Act 2005, and where Part 4 or 4A of the Mental Health Act 1983 applies, in accordance with that Act instead.
The regulation does not describe a form, a signature or a retention period. It describes a state of affairs that must be true before treatment happens. That is why a consent system is assessed on whether it can show the state of affairs rather than on whether it stores the artefact.
This is consent to care and treatment, which is a separate question from consent to being recorded during a consultation. The second is governed by data protection law and, in the United States, by state recording statutes, and it is covered in do you need patient consent for an AI scribe.
The standard is material risk, and it is not in the regulation
In Montgomery v Lanarkshire Health Board the Supreme Court held in 2015 that a doctor must take reasonable care to ensure a patient is aware of material risks in a proposed treatment and of reasonable alternatives. Materiality is judged by what this particular patient would be likely to attach significance to rather than by what a body of clinicians would disclose.
That is the sentence a consent system has to survive. A standard form carrying the same list of risks for every patient cannot evidence a patient specific discussion, because its content is identical whoever signed it. What distinguishes a record is the part that varies, which is what was actually said to this person about their circumstances.
The detached consent, and why it is common
The usual arrangement in a private clinic is that consent lives in a document store and the consultation lives in a clinical record, joined by a patient name and a date. That works until somebody asks a question about sequence, at which point the join is an assumption rather than a fact.
Two sequences matter and neither survives a loose join. Whether consent preceded the procedure, and whether the discussion preceded the signature. A form completed and signed in the same minute as a procedure started is a legitimate record of an urgent decision and an uncomfortable one for an elective treatment, and a system that stores only an upload time cannot tell the two apart.
Withdrawal, which almost nothing models
Consent is not a single event. It can be withdrawn, narrowed or given for one part of a plan and not another, and each of those is a clinical event with an author and a time. Most systems hold consent as a document that exists or does not, which models only the first of them.
The practical consequence is that a patient who agreed to a procedure and later declined one element of it generates a record that reads as full agreement. The control is that consent is stored as a history rather than as a file, and our page on what documentation software has to prove covers why the same distinction decides the records question.
What we are not claiming
This page describes what the regulation requires and what a system can evidence. It is not legal advice, it is not clinical guidance on taking consent, and it does not substitute for your registered manager's judgement or for the guidance published by CQC and by the professional regulators. Where a decision turns on detail, the legislation and the judgment linked below govern rather than this summary.
wai is not CQC registered and makes no claim to be. CQC registers providers of regulated activities rather than software. The registration and the duty stay with the clinic.
Where wai sits
wai keeps the consultation, what was explained in it and what followed on one record, so consent sits next to the discussion it came out of rather than in a separate store joined by a date. A clinician authorises every patient-affecting action, and every read of a record is logged against a named role.
We are specific about the boundary. wai does not decide whether consent is valid and should not, because that is a clinical judgement about a particular patient. What it holds is the account of the conversation, which is the part that is usually missing. The wider map is in software and CQC, what is actually being assessed.
Ask any supplier on your list, including us, to show one consent record with the discussion attached and the clinician who held it named. Clinicians still decide what enters the record.
Request one consent record with the discussion attached rather than the signature alone. Most systems hold only the second.
Request a demoFrequently asked questions
What does Regulation 11 require about consent?
That care and treatment are only provided with the consent of the relevant person. Where somebody aged 16 or over lacks capacity to consent, the registered person must act in accordance with the Mental Capacity Act 2005, and where Part 4 or 4A of the Mental Health Act 1983 applies, in accordance with that Act.
Is a signed consent form enough evidence of consent?
No. A signature evidences that a document was signed. Regulation 11 asks whether consent was given, which turns on what was explained, by whom and when. A form whose content is identical for every patient cannot evidence a patient specific discussion.
What did Montgomery change about consent records?
Montgomery v Lanarkshire Health Board, decided by the Supreme Court in 2015, held that a doctor must take reasonable care to ensure a patient is aware of material risks and of reasonable alternatives, with materiality judged by what that patient would attach significance to. The part of a record that evidences it is the part that varies between patients.
Why does the timing of consent matter to a system?
Because two sequences are assessed. Whether consent preceded the procedure, and whether the discussion preceded the signature. A system that records only when a document was uploaded cannot show either, so a form signed in the same minute as a procedure began looks the same as one discussed a week earlier.
How should withdrawal of consent be recorded?
As an event with an author, a time and a scope, in the same history as the original consent. Most systems hold consent as a document that exists or does not, so a patient who later declined one element of a plan leaves a record that reads as full agreement.
Does wai decide whether consent is valid?
No, and it should not. Validity is a clinical judgement about a particular patient. What wai holds is the account of the discussion, who held it and when, on the same record as the treatment it relates to, which is the part most often missing when somebody asks.
Sources
One consent record, with the discussion attached
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