01 May 2018
01 May 2018
Ref: CH (18) 03
Dear colleague,
Update of third-party patient record systems used to submit data to the HFEA Register
A key strand in implementing the new data submission system (PRISM) is that all clinics can continue to submit Register data to us in accordance with a new Direction (ie. General Direction 0005 version 5 will come into force with the implementation of PRISM, our new data submission system). We will provide the revised General Direction nearer the implementation date.
An increasing number of clinics now submit treatment information to us via third-party patient record systems. Providers of those systems now need to make changes such that the benefits that flow from the changes being made are available to all clinics as soon as possible. We plan for clinics that enter data directly into the HFEA Register to move over to the new data submission system (PRISM) at the same time as clinics that use 3rd party systems. Synchronizing the changes will minimise disruption to related activities, such as your and our monitoring of your performance, fee billing and so on.
Our usual practice is to provide clinics that use third party patient record systems and their suppliers sufficient notice for their system suppliers to implement proposed changes. We have been in regular contact with system suppliers alerting them to the changes required but it is clinics that have a contractual relationship with the supplier and a legal duty to submit register data to the HFEA.
We now require clinics that use third-party patient record systems to give their system suppliers formal notice of the requirement for them to have made the necessary changes to their software to ensure your clinics continued ability to submit register data to the HFEA from 1 October 2018. Notice should be given to your system supplier by 18/05/2018.
We will work closely with suppliers to make the necessary changes to ensure compatibility with the HFEA’s new data submission system by 1 October 2018. However, in the event that appropriate changes have not been implemented during the preparatory period signalled by your formal notice, such that the system is ready for submissions, it will be necessary for you to use an alternative compatible system or the HFEA’s own data submission system (PRISM direct-entry) to submit Register data as required by Direction 0005 (Version 5) – as you know failure to submit register data in accordance with General Direction 0005 is a breach of licence conditions and may result in regulatory sanction.
Yours sincerely,
Sally Cheshire CBE
Chair, Human Fertilisation and Embryology Authority