Clinical recordings and the Correct Consent

In all specialities of medicine patient clinical recordings, whether this is photographs or visual investigations, are imperative1. Not only are they required for diagnosis and treatment of the patient, but use also extends to teaching and research publications1. Under the data protection act (2018)2 and in accordance with patient safety, it is important that patient consent is obtained primarily for the clinical recording itself and, if required, how these recordings may be used thereafter. 

Although closely linked, patient confidentiality is itself a standalone topic that will be touched on, however for further more in-depth guidance which also covers disclosures in the public interest please refer to further reading GMC’s guidance in Confidentiality3. Similarly, patient capacity is also its own entity, and whilst this article will focus on adults who have capacity to consent, as we always must begin with the assumption that patients have capacity, further GMC guidance for taking consent in patients who lack capacity can also be found in further reading4.

This article will highlight key concepts around consent for clinical recordings, which type should be used and when, as well as how this extends to referrals, teaching and publications.  Gaining informed consent is one of the core concepts in medicine and helps to build both trust and rapport in the Doctor-Patient relationship, without which patients may avoid seeking medical care at all together.

When is it needed?

  • Before any type of medical treatment, including clinical recordings.
  • Consent in some form must be obtained; this is in compliance with human rights law and medical ethics.

When is it considered valid?

  • When is it informed.
    • Informed means the patient understands the procedure, risks, benefits and alternatives.
  • When it is voluntary (without pressure or coercion).
  • When it is from a patient you have no reason to believe lacks capacity.

Withdrawal of consent should always be an option.

Types

  • Written consent
  • Verbal consent
  • Implied consent i.e. For example holding and arm out for a blood pressure reading.
2. Clinical recordings

Clinical Photographs

  • Written  consent should always be gained before taking a clinical photograph.
  • Most trusts have their own policy document which the patient can sign and date.
  • Often this contains a body map illustration so the areas where images have been taken can be highlighted.
  • This can be stored in the patient’s records.

Clinical Investigations

  • Verbal/implied is usually gained when the patient has the procedure which creates the image and further consent does not need to be obtained.
  • Images created include ECG, USS, CT, X-ray, Laparoscopic.
1. Referral

Any clinical recordings form part of the patient care record and any sharing of patient information introduces risks to patient confidentiality if improper consent has been obtained3:5. That being said, referral of clinical images and visual investigative results to other colleagues is regularly essential to ensure safe and effective direct patient care5. Most patients expect that their medical information will be shared with the team or teams looking after them and this is acceptable under implied consent if the following requirements are met3:

  • Accessing patient data because you are directly involved the patient’s care.
  • Satisfied anyone you disclose the patient’s information to is also bound to respect confidences.
  • Information about how their data is being use is made readily available to patients.
  • Patients have a right to object and this can be discussed further with them.
2.Transferring and the use of mobile devices

Utilising services available within trusts for the transfer of patient data is in the first instance ideal. However with this not always being readily available research has shown an increase in the number of doctors using their own personal smartphones in the hospital setting to take and refer patient clinical recordings for patient care8:9. The following advice is available for using personal mobile devices:

  • Benefit to patient care will be achieved by using the mobile device.
  • Consent has been gained, is informed and documented.
  • Safest method of patient data transfer to maintain patient confidentiality is used.
    • NHS.net or NHS inboxes can be used to securely send and receive images. 
    • Trust accessed platforms which can have images uploaded to them.
    • Secure clinical image transfer apps  which are encrypted.
    • The current NHS guidance for using other mobile apps such as ‘Whatsapp’ for transferring any patient data is that it should not be used in the professional healthcare environment as they have no data security certification for patient information or details of clinical cases.10
  • Anonymised or pseudonymised  patient data is sent wherever possible.
  • Remove images from the original device one they have been transferred.
  • Password protection should be used on all devices with access to images.

Further guidance when on the use of mobile devices can be found from the BAD8. (Available in further reading).

It is recognized that the benefits of sharing patient information for teaching and in research publications, is not only of benefit to clinicians but also ultimately improves patient care7:8. However, appropriate consent to the use of clinical recordings in teaching and research is determined by the initial reason why the recordings were created. Images can be created either for the primary purpose of patient care or secondary for a reason not related to patient care5:11.

1. Primary purpose

Clinical recordings are taken initially for patient care.5:7:11

Anonymised

  • No Further consent for teaching and research is required.
  • Clinical recordings used must have all patients identifiable information removed e.g. Name, Hospital ID, Hospital Name and Study ID.
  • However careful consideration regarding consent is required before publishing in journals and other learning material and it is always best practice to have documentation.

Non anonymised

  • Documented explicit consent for teaching or publication must be obtained.
  • Consent for secondary purpose can be obtained at the time of the primary clinical recording.
2. Secondary purpose

Clinical recordings are taken for reasons other than patient care e.g. teaching or research.5:11

  • Documented explicit consent for the stated purpose should always be obtained.
  • Anonymisation of patient details is still best practice and ethical.

Further reading

  1. GMC’s guidance Confidentiality: good practice in handling patient information Available at GMC3
  2. GMC’s guidance Decision making and consent: taking a proportionate approach Available at GMC4
  3. UK Guidance on the Use of Mobile Photographic Devices in Dermatology Available at BAD8

References

  1. Dysmorphology subcommittee of the clinical practice committee, American College of Medical Genetics et al., (2000) “Informed consent for medical photographs” Genetics in medicine, Official journal of the American College of Medical Genetics vol. 2,6 pp. 353-5
  2. GOV UK (2018) “Data Protection Act 2018” Last updated 2018 Available at https://www.legislation.gov.uk/ukpga/2018/12/contents/enacted/data.htm
  3. GMC (2017) “Confidentiality: good practice in handling patient information” Lasted updated 01.2017, Available at https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors—confidentiality-good-practice-in-handling-patient-information—-70080105.pdf?la=en&hash=08E96AC70CEE25912CE2EA98E5AA3303EADB5D88
  4. GMC (2020) “Decision making and consent: taking a proportionate approach” Last updated 09.11.2020, Available at https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent/taking-a-proportionate-approach
  5. GMC (2013) “Making and using visual and audio recordings of patients” General Medical Council, Last updated 03.2013 Available at https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/making-and-using-visual-and-audio-recordings-of-patients#
  6. Shah P, Thorton I, Turrin D et al., (2021) “Informed consent” StatPearls Publishing, Last updated 06.2021, Available at https://www.ncbi.nlm.nih.gov/books/NBK430827/
  7. NHS (2019) “Consent to treatment” Last updated 03.19, Available at https://www.nhs.uk/conditions/consent-to-treatment/
  8. BAD (2017) “UK guidance of the use of mobile photographic devices in Dermatology” British Association of Dermatologists PDF 
  9. DERMNET NZ, Yung A, (2017) “Image Acquisition in Dermatology” Last updated January 2017 Available at https://dermnetnz.org/topics/image-acquisition-in-dermatology/
  10. MDU (2018) “Protecting patient data” Last updated 21.05.2018, Available at https://www.themdu.com/guidance-and-advice/guides/protecting-patient-data
  11. Royal College of Radiologists (2017) “Guidance on the use of patient images obtained as part of standard care for teaching, training and research” Last updated 2017, Available at https://www.rcr.ac.uk/publication/guidance-use-patient-images-obtained-part-standard-care-teaching-training-and-research

Edited by Mudassar Khan (Y4 Medical Student)

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