To say 2020 has been an unprecedented year is an understatement and a cliché. But the pandemic has changed things in our personal and professional lives forever.
Nobody could have anticipated the upheaval we were about to face and this meant many private and public health organisations faced challenges as they navigated the unknowns of Covid-19.
Patient safety was a concern and many practitioners had to make the difficult decision to postpone appointments and treatments while awaiting news and guidance on protecting staff and patients against the virus. This included fertility treatment.
Like with everything else, the pandemic has changed the fertility treatment process in the short-term and as with other industries, technology has been a huge help in ensuring services can still be provided.
Many patients have waited years to start fertility treatment and the delays and cancellations have been difficult for them to cope with. Although many clinics were physically closed to patients they continued to provide support and guidance via video appointments, alleviating patient concerns and keeping communication flowing.
The new normal for fertility treatment
Clinics were subsequently able to reopen with additional safety measures in place, providing they adhere to Human Fertilisation and Embryology Authority (HFEA) guidance.
Minimising contact has been paramount and clinics have looked for ways to reduce in-person visits where possible. One element where this is possible is the consent process.
The forms required to begin fertility treatment are extensive and can take up to 45 minutes each to complete. These forms require thorough reading by the patient in order for them to provide informed consent, so the process should not be rushed.
It is important for patients to feel comfortable and supported when signing these consent forms and, although every effort has been made to make the clinic environment safe, might feel anxious spending prolonged periods of time in a clinic, under pressure to complete the forms as quickly as possible.
Providing the option to sign consent forms in the safety and comfort of their own homes can ease patient concerns while also reducing clinic visits.
The HFEA has issued guidance on consent form completion during the pandemic, stating:
Consent should be given at the clinic (with both parties present if a couple is being treated) or a documented process should be in place to ensure that consent forms signed outside the clinic are signed by the correct person, have been correctly completed and the consent is valid.
Therefore, if clinics have a documented process in place to ensure the identity of their patients, and to ensure the forms are completed correctly, consents can be signed outside of the clinic.
The pandemic has accelerated a trend that has been growing in fertility clinics – digital consent. Many clinics have already adopted an electronic consent process as part of their digitisation initiatives. At a time when many clinic staff are working from home, having a centralised online record of patient information minimises the risk of error and enables clinics to continue to provide regular services and consultations.
Ensuring patient data is secure
In line with HFEA regulations, clinics need to ensure that electronically signed consent forms provide evidence of a valid, compliant signature, proving that documents have been signed by the correct person. The eIDAS regulation provides a set of standards for the use of electronic signatures across Europe.
A Qualified Electronic signature is compliant with HFEA’s requirements for consent as:
- It is uniquely linked to the signatory;
- It is capable of identifying the signatory;
- It is created using electronic signature creation data that the signatory can, with a high level of confidence, use under his sole control; and
- It is linked to the data signed therewith in such a way that any subsequent change in the data is detectable
This ensures that an electronically signed consent form can be linked to the signer, provides evidence of when it was signed and will become invalid if it is tampered with. This form of electronic signature is as secure and legally binding as a ‘wet’ ink signature.
For NHS clinics, there is the additional requirement of compliance with NHS Digital Data Security and Protection toolkit standards, as well as GDPR and other data protection governance.
The future of fertility treatment
While it looks like this new normal is here to stay, fertility clinics have been quick to adapt and offer support to patients. The consent process can take a considerable amount of time but while fertility treatment is still facing delays, clinics can utilise technology to provide patients with online consent services.
What is important is that fertility clinics ensure that the consent technology used to provide patient services is secure, robust and compliant with HFEA regulations to avoid unnecessary disputes.
This article was first published in The Journal of mHealth in February 2021.