Summary
Regulation 17 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires an accurate, complete and contemporaneous record in respect of each service user. Contemporaneous is the word that decides whether a documentation system helps, because it means the record was made at the time rather than written up later from memory, and a system that stores only the final text cannot tell the two apart. Four facts carry the evidence. When an entry was created, who created it, what it said before any edit, and who approved the change. A system that overwrites rather than versions can produce none of them, however good the note reads.
The question comes up in every assessment and most procurement conversations. What do you use for documentation. The answer people give is a product name, and the answer the question is reaching for is what that product can show.
Regulation 17 is short and the word that does the work is contemporaneous. A record written up at the end of a clinic is not the same as a record made during one, and a system that cannot distinguish them cannot evidence the difference on your behalf.
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See it in your clinicThe draft, every edit to it and the clinician who approved it, on one record with its own history.
Request a demo| Fact | Why it is asked for | What happens when a system cannot show it |
|---|---|---|
| When the entry was created | Contemporaneous means made at the time. A timestamp on the save tells you when it was typed, not when the care happened | The record cannot be distinguished from one reconstructed days later |
| Who created it | Attribution is the first thing checked when an entry is disputed | Everything in a shared login is attributable to nobody |
| What it said before an edit | An amended record is legitimate. An amended record with no earlier version is a record whose history was deleted | A correction and a rewrite look identical |
| Who approved the change | A clinician is the author of their note whatever drafted it | Nobody can show the clinical decision was a person's |
What Regulation 17 asks for
Regulation 17 sits in the fundamental standards and covers good governance. Within it is the requirement to maintain securely an accurate, complete and contemporaneous record in respect of each service user, including a record of the care and treatment provided and of decisions taken in relation to that care and treatment.
The same regulation requires systems to assess, monitor and improve quality, and to assess, monitor and mitigate risk. Those are two different asks of a documentation system. One is about each individual record being right. The other is about being able to look across all of them and notice something, which most clinical systems are poor at because they were built to store a note rather than to report on a thousand.
Why contemporaneous is the hard word
A note typed at nine in the evening about a consultation at eleven in the morning is not contemporaneous, and everybody knows it. What is less obvious is that most systems record only the moment of saving, so the nine o'clock note and the one dictated during the consultation are indistinguishable once stored.
That is the gap an ambient system closes almost by accident, because capture happens during the consultation and the draft exists before anybody types. It is also the gap it can widen, if the draft sits unreviewed for a week and is then signed without being read. Our page on monitoring an AI scribe once it is live covers what to watch for exactly that.
A record that carries its own history
Amending a clinical record is normal and expected. A clinician reads a draft, corrects a dose, removes something the patient did not say and signs. What matters is whether the system can later show that this is what happened, rather than presenting the corrected version as though it were the original.
The test to put to a vendor is specific and it is not a feature question. Request an export of one record showing its full history, including superseded versions and who approved each change. A system that can produce it will produce it in minutes. A system that cannot will explain why the question is unusual.
Shared logins, which undo all of it
Every control above depends on knowing which person did something, and a shared login removes that in one step. It is still common in small clinics, usually for reception or for a locum who was never set up properly, and it converts an audit trail into a list of events attributable to an account rather than a human.
This is worth checking before buying anything, because it is a configuration failure rather than a product failure and no purchase fixes it. A system that makes adding a named user slow or expensive will produce shared logins whatever the policy says, which makes per user cost a clinical governance question rather than only a commercial one.
What we are not claiming
This page describes what the regulation requires and what a system can evidence. It is not legal advice and it does not substitute for your registered manager's judgement or for the guidance CQC publishes. Where a decision turns on detail, the legislation linked below governs 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 drafts the note during the consultation rather than after it, and the draft, the edits made to it and the clinician who approved it sit on one record. Every read of a patient record is logged against a named role, and nothing reaches a patient without a person approving it.
That is not a compliance feature. It is what makes the clinician the author of their own note, and the evidence it happens to produce is a consequence. The broader map of which regulations a clinic's systems have to answer is in software and CQC, what is actually being assessed.
Request a sample audit trail from us before the demo. If a supplier will not export one early, including us, that is the answer to the question. Clinicians still decide what enters the record.
Request a sample audit trail before the demo. A system that cannot export one has answered the question.
Request a demoFrequently asked questions
What does Regulation 17 require of clinical records?
That the provider maintains securely an accurate, complete and contemporaneous record for each service user, including the care and treatment provided and the decisions taken about it. The same regulation also requires systems to assess, monitor and improve quality and to mitigate risk, which is a reporting ask rather than a record keeping one.
What makes a clinical record contemporaneous?
That it was made at the time of the care rather than reconstructed afterwards. Most systems store only the moment of saving, so a note typed hours later is indistinguishable from one made during the consultation. Evidencing it needs the system to know when the entry was created rather than only when it was stored.
Can a clinical record be amended?
Yes, and amendment is normal. What matters is that the system retains the superseded version and records who approved the change, so a correction and a rewrite can be told apart later. A system that overwrites presents the corrected version as though it were the original.
What should I ask a documentation vendor to prove?
Request an export of a single record showing its full history, including superseded versions, the time each entry was created and who approved each change. A system that can do it will do it in minutes. The ones that cannot tend to explain why the question is unusual.
Why do shared logins matter for records?
Because every control described here depends on knowing which person acted. A shared login turns an audit trail into events attributable to an account rather than a human, and no purchase fixes it. A system that makes named users slow or costly will produce shared logins whatever the policy says.
Does an AI scribe make records more or less compliant?
Either, depending on how it is run. Capture during the consultation closes the contemporaneous gap. A draft left unreviewed for a week and then signed unread widens it. The control is that a clinician reads and approves before anything is saved, and that the approval is visible on the record.
Sources
A sample audit trail, before the demo
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