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Laws & regulations

The rules for blood testing & diagnostics clinics.

Blood testing combines health data, medical devices, and lab quality, and patients are trusting you with all three. These are the rules we design around.

5 specific rules · plus 9 for every clinic · Last reviewed 10 November 2026

How we build for blood testing & diagnostics clinics
01LawICO · UK GDPR

Booking and results as health data

Read the source (opens in a new tab): ICO, What is special category data?

What it says

Booking a blood test can reveal something about a person's health, so booking data is special category data. Results are more sensitive still.

Your website
Lean booking forms, and no tracking pixels on booking or results pages.
Your systems
Results published to a secure patient account, not sent by email.
How we work
No direct impact.
02RegulationCQC

CQC: diagnostic and screening procedures

Read the source (opens in a new tab): CQC, Regulation 20A

What it says

Diagnostic and screening procedures is a regulated activity in England, so check whether your service needs CQC registration, and show your rating once you have one.

Your website
Your CQC registration and rating shown where patients look for them.
Your systems
No direct impact.
How we work
No direct impact.
03RegulationMHRA

Home test kits as in vitro diagnostic devices

Read the source (opens in a new tab): GOV.UK, Regulating medical devices in the UK

What it says

Home test kits are in vitro diagnostic medical devices, so they need the right UK conformity marking to be sold in Great Britain.

Your website
Kit pages that show the supplier and marking, so patients can see what they are buying.
Your systems
Kit records that carry the supplier and lot number for each order.
How we work
No direct impact.
04StandardUKAS

ISO 15189 laboratory accreditation

What it says

ISO 15189 is the quality standard for medical laboratories, and UKAS accredits labs against it in the UK.

Your website
Your partner lab's accreditation shown on test pages.
Your systems
No direct impact.
How we work
No direct impact.
05GuidanceClinical governance

Clinical review before results are released

What it says

Results should be checked by a clinician, and abnormal results acted on, before patients are left to read them alone.

Your website
No direct impact.
Your systems
Reports locked until a clinician signs them off, and abnormal results flagged for a call first.
How we work
No direct impact.

Built in, not bolted on

A site that follows the rules.

We build every rule on this page into the websites and systems we make for blood testing & diagnostics clinics. This is a plain English summary, not legal advice, so check each source and take advice from your regulator, indemnity provider, or clinical lead.