Abortion (Scotland) Amendment Regulations 2021 – proposed changes: business and regulatory impact assessment

This business and regulatory impact assessment (BRIA) considers the proposals for changes to the Abortion (Scotland) Regulations 1991 to enable notifications of abortions to be sent to the Chief Medical Officer electronically and to avoid personal data about patients being included in future notifications.

4. Options

The Scottish Government has considered three main options for abortion notifications as follows:

  • Option 1: Do nothing
  • Option 2: Allow electronic submission of data, but still via CMO
  • Option 3: Allow simple electronic (email) notifications to CMO, with patient abortion data submitted directly to PHS

4.1 Sectors and groups affected

These proposed changes affect abortion providers – in this case this is those services operated by NHS Boards and the one private provider which is approved by Scottish Ministers to provide abortions in Scotland. The changes will also affect PHS. All these groups have been involved in discussions and/or the public consultation on the proposals and have been generally supportive of the proposals.

4.2 Costs and Benefits

Option 1: Do nothing

This option would involve the 1991 Regulations and the arrangements they provide for remaining in place, with notifications and patient data being sent on paper forms to the CMO within 7 days, for onward transmission to PHS.

This option presents no additional costs e.g. for updating electronic systems. However it would mean that the current inefficient approach is retained requiring data to go, in hard copy, via the CMO, which includes additional risks to data security.

It would continue to require providers to fill in notification forms on paper and send or deliver them to the CMO's office for onward transmission to PHS. PHS staff would then continue to type the information into their database for use to produce the abortion statistics. The paper forms would continue to need to be stored securely for six years and then securely destroyed.

Option 2: Allow electronic submission of data, but still via CMO

This option would involve the establishment of an electronic system for providers to submit notifications and patient data to the CMO and for the CMO to submit patient data to PHS.

This option would include costs for Scottish Government for the setting up of the new system and costs for PHS to update its systems to receive data electronically from the Scottish Government (CMO). It would not be expected to include additional costs for providers as instead of entering the data by hand on the paper form, it would be entered directly onto the electronic system.

This approach would enable providers to provide just one set of data (notification of the termination and patient data), via a web-based form or IT system, to CMO, who would then be able to share the data with PHS, ideally through an automated system to avoid CMO office staff having to manually enter the data.

This would have the benefit of making the process electronic and so minimise risks of errors or missing data in the forms (for example through drop down boxes or mandatory data fields in the form). It would also reduce postal costs for abortion providers and would reduce the impacts of printing around 13,000 papers forms per year (printed by Scottish Government), which are transported to and from providers and from CMO's office to PHS.

However, this approach would still have the disadvantage and potential risks of CMO receiving personal data about patients and passing it on to PHS, albeit electronically. In order to comply with the requirements of the Abortion Act 1967, the IT system required would also be likely to be more complex as the data would need to come to the CMO first (through the Scottish Government firewall) and then be released on to PHS (as the data could not be sent to both parties at the same time).

Option 3: Allow simple email notifications to CMO, with patient abortion data submitted directly to PHS

The third option, which is the proposed option, would involve RMPs sending notification of terminations to the CMO which include no patient data, by email. In practice, RMPs would notify multiple terminations at once, by indicating the number of terminations they have carried out over a specific time period.

Patient data would be sent directly from providers to PHS, using an existing electronic system, which will be updated for this purpose. The specific range of data to be provided to PHS in relation to each termination would be established separately by PHS in discussion with providers (they have already had initial discussions on this). As part of that discussion, PHS is discussing with providers the information they currently collect in order to ensure as far as possible that they seek data from providers which is either already collected or can readily be provided.

The CMO's office would compile the notifications and share numerical data from them (the number of terminations per NHS Board) with PHS so PHS could compare against the data it is receiving from Boards to ensure it is receiving data in relation to all terminations.

This option, which is the proposed option, will include costs for PHS associated with the updating of its IT system to receive detailed abortion data directly from providers electronically, rather than through paper forms sent via the CMO. The estimated cost of this is approximately £36,000 to enable NHS Board staff to have access to allow them to enter data directly into PHS' IT system (although NHS Boards will only have access to the records they have entered into the system and not to any other data in the database). This investment will allow for future proofing so that, for example categories of drop down options can be easily updated in future. It would also involve reduced data entry work for PHS as its staff would no longer need to input data from the yellow forms, as this would be done by the individual providers.

It is not expected to lead to additional costs for providers, as they will still be providing patient data per abortion, but will enter it directly into the PHS electronic system, rather than by hand onto the yellow form. Using an electronic form with drop down options should make the completion of the data less time consuming than having to enter all the fields in writing by hand and will also reduce the potential for missing data which requires to be queried by PHS and therefore often needs Board staff to check to find the missing data.

This option has the benefit of streamlining the process to avoid the risks associated with the CMO receiving and needing to pass on personal data about patients. By enabling personal and other data about patients having abortions to be provided directly to PHS by providers via secure means this minimises the number of people having access to this sensitive data and therefore should help ensure data security.

Increasing the timescale in which RMPs must provide notifications to the CMO, and enabling notifications of multiple abortions to be provided at once, meaning in effect a notification can be made monthly, will have a benefit for providers.


Email: sam.baker@gov.scot

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