Consultation outcome

Information standards for health and adult social care in England: consultation response

Updated 22 November 2024

Introduction

This document sets out the Department of Health and Social Care’s (DHSC) response to a consultation about proposals for regulations to make provision about the procedure to be followed for the preparation and publication of information standards. 

Information standards in relation to the health and adult social care sector are those standards relating to the processing of information, prepared and published under section 250 of the Health and Social Care Act 2012.

Changes were made by the Health and Care Act 2022 and further changes are proposed by the Data Use and Access Bill, which is currently before Parliament. 

The changes made by the Health and Care Act 2022 need to be commenced, which will formally bring them into effect. These changes will: 

• make compliance with information standards mandatory
• extend information standards so that they may also apply to private health and adult social care providers

These changes also require proposed regulations (the regulations) to set out the procedure to be followed in preparing and publishing information standards.  

The Secretary of State for Health and Social Care is required, before laying a draft of the regulations before Parliament, to consult such persons as the Secretary of State considers appropriate. DHSC undertook the consultation as the responsible department for the development and delivery of the regulations. 

The consultation invited views on the proposals for the procedure to be set out in regulations in connection with the preparation and publication of information standards. 

Overview of consultation activity

The consultation was launched on 15 February 2024 and ran for 6 weeks, until 28 March 2024.   

There were 132 responses to the consultation. Of these, 56 (42.4%) responded on behalf of an organisation, 55 (41.7%) as an individual sharing their professional views, and 21 (15.9%) as an individual sharing their personal views (see table 1) 

Table 1: In what capacity are you responding to this consultation?

Response	Count	Percentage
On behalf of an organisation	56	42.4%
An individual sharing my professional views	55	41.7%
An individual sharing my personal views and experiences (such as a patient, carer or member of the public)	21	15.9%

For those responses made on behalf of an organisation, or by an individual sharing their professional views, there was a similar proportion of responses from public sector health and social care providers (28.8%) and suppliers of products or services to the health and social care sector (34.2%). Private sector health and social care providers accounted for 9.0% of responses (see table 2).  

Table 2: Which of the following best describes your area of work?

Response	Count	Percentage
IT provider of products or services to the health and social care sector	38	34.2%
Health or social care provider (public sector)	32	28.8%
Other or no answer	31	27.9%
Health or adult social care provider (private sector)	10	9.0%

Summary of responses

Regulations about procedures in connection with preparing and publishing mandatory information standards

Main themes 

In general, responses received were in support of the proposals, with a few suggestions for refinements or additional procedures. For example: 

• 96.2% of respondents agreed that the Secretary of State or NHS England should be required to obtain advice before preparing an information standard
• of a potential list of information to be included when publishing information standards, 6 of the 10 specified items on that list received greater than 90% support from respondents
• 77.3% of respondents considered that regulations should specify the minimum interval for reviewing information standards
• responses emphasised the importance of making clear the consequences of non-compliance with information standards

The responses have been very helpful to us in considering our proposals and shaped our decision to make some adjustments to address the comments made. Since the regulations are subject to the affirmative Parliamentary procedure, our proposals are subject to Parliament’s approval of the regulations and the proposals below should be read accordingly.

For full details of the survey responses, see the ‘Detailed responses and analysis of survey questions’ section below.

There were a few areas in particular for which the responses to the consultation have influenced the proposed regulations. These are as follows.

Obtaining advice and additional considerations 

Acknowledging the strong consensus around the importance of involving stakeholders when preparing or revising information standards, the regulations would include a requirement for the Secretary of State or NHS England to obtain advice - from such persons as considered appropriate - before preparing an information standard, and to have regard to that advice. Revisions will be considered on a case-by-case basis, with involvement from stakeholders as necessary.

It is intended that supporting guidance would make clear that ‘such other matters’ could include the impact on provision of services and capacity of the health and adult social care system to implement a new standard, where appropriate.  

Responses also indicated support for consideration of ‘interoperability and integration with existing IT systems’ before preparing an information standard. Given the broad scope of information standards, which extends beyond interoperability, it is important to maintain sufficient flexibility in procedures. Therefore, it is our intention, when implementing mandatory information standards, to prioritise those which will contribute most to interoperability objectives, where appropriate.  

Information to be included with an information standard when published 

Responses emphasised the importance of making clear the consequences of failure to comply and so the intention is that the regulations would set out a requirement for such a statement to be included in an information standard when published.

In addition, given the emphasis placed in responses on the importance of ensuring sufficient lead-in time, it is our intention to provide such lead-in time wherever possible, for example, by giving advance notice of information standards, where appropriate.

In summary, the list of proposed information to be included within an information standard when published, based on the consultation and responses received, are: 

• name of the information standard
• date on which it was published
• the fact that it must be complied with
• the consequences of failure to comply
• the fact that the Secretary of State may require a person to provide the Secretary of State with documents, records or other information for the purposes of monitoring the person’s compliance with information standards
• information on any guidance about implementation of the standard
• a list of changes to the information standard, for example, revisions over time
• the person who prepared the information standard and their contact details
• information on the interval at which the information standard is to be reviewed
• such other information as the decision maker considers appropriate

Several responses supported including the following additional detail with an information standard when published:

• any related information standards
• purpose of the information standard
• sectors which the information standard applies to

It would be open to the decision maker to include such other information with an information standard where they consider it appropriate. However, this would depend on the circumstances, and it is not considered necessary to require these to be routinely included.

Reviewing an information standard 

Responses were supportive of the regulations setting out the minimum interval for reviewing an information standard, however responses were divided as to what the minimum interval should be. On balance, it is not considered feasible to set out a minimum interval in the regulations due to the need to ensure sufficient flexibility for changing circumstances, given the broad scope of information standards and to allow administrative arrangements to be set up and kept up to date within basic structures and principles set out in the regulations. Therefore, it is our intention that the regulations would require information standards to be reviewed periodically or at appropriate intervals, with discretion as to the interval period. 

Revisions, revocations and adopting existing information standards 

There was broad support for revocations and adopting existing standards to go through the full procedure and this is what we intend the regulations to provide. 

Responses were mixed in relation to the procedure for revisions to information standards and many responses indicated the need for flexibility to consider the procedure for revisions to information standards on a case-by-case basis.  

After careful consideration, our intention is that the regulations would not require revisions to information standards to go through the full procedure but would allow a measure of flexibility in this regard. This is to ensure that information standards can be maintained in the most efficient manner possible.  

Other procedures to be followed 

Suggestions for any other procedures that should be followed in connection with the preparation and publication of information standards broadly fell into 5 themes. This feedback has been considered carefully and our intentions are outlined below.

1. Stakeholder and public involvement

On the basis that requiring stakeholder, or patient, involvement in all cases would be disproportionate and cumbersome, our intention is that regulations would place a duty on the Secretary of State or NHS England, as the case may be, to seek advice before preparing an information standard. In practice, such advice could include advice from stakeholders.

2. Consequences of non-compliance

Regulations would require the consequences of non-compliance to be included with an information standard.

3. Timescales

There are existing programmes of work that aim to enable health and adult social care organisations to plan the implementation of standards and ensure sufficient time to prepare. This includes producing a future standards roadmap which provides an overview and estimated timescales of new standards that are proposed or in development, or any planned changes to existing standards.

In addition, our intention is to provide sufficient notice for organisation to implement information standards, wherever possible.

4. Minimum compliance standards

Although we appreciate the intent behind this suggestion, in practice having different potential ‘levels of compliance’ within a given standard would not sit well with the spirit of the legislation and would also be complex to monitor and enforce, therefore this suggestion will not be taken forward. We will, however, be clear what is needed to comply with an information standard.

5. Language and accessibility

We are committed to working to ensure accessible and straightforward language is used across our work, including in relation to information standards.

Next steps

We are grateful to all respondents for taking the time to consider this consultation. We have taken on board the feedback and used the analysis of responses to inform the drafting of the regulations - which would set out the procedures to be followed to prepare and publish information standards. Responses will also inform the contents of any supporting guidance, which may accompany the regulations.   

The regulations are subject to the affirmative Parliamentary procedure and we hope to lay regulations before Parliament in spring 2025.   

DHSC and NHS England will continue to engage with stakeholders going forward, including when planning the implementation of mandatory standards. This is to better ensure we can deliver, while keeping the needs of stakeholders across the health and care system front and centre.

Detailed responses and analysis of survey questions

Seeking advice 

The overwhelming majority of respondents (96.2%) were in support of a duty for the Secretary of State or NHS England to obtain advice before preparing an information standard, for example from an advisory board or other persons.

There was strong consensus that a number of sectors should be represented on such an advisory board - with publicly-funded health and care providers as the top choice with 90.2% of respondents agreeing that, of the potential list, these should be included (see table 3).  

A significant number of answers suggested that other areas should be represented, including:  

• standards bodies
• professional bodies
• academics and research institutions
• regulatory bodies such as the Care Quality Commission
• local authorities
• relevant charities

Table 3: Which of the following areas should be represented on such an advisory board or included as other persons from whom advice is sought?

Response	Count	Percentage
Publicly-funded health and care providers	119	90.2%
Patient and public representatives	108	81.8%
Representatives of NHS England	107	81.1%
Privately-funded health and care providers	106	80.3%
Health and care providers that are funded in part publicly and in part privately	106	80.3%
IT suppliers	98	74.2%

Responses to this question from IT suppliers and health and care providers were broadly similar, with the main exception of seeking advice from IT suppliers - which 94.7% of IT suppliers and 69% of health or social care providers, respectively, were in support of. 

Additional considerations

In relation to a potential list of additional factors for the Secretary of State or NHS England to consider before preparing an information standard, respondents gave strong overall support for consideration of the impact on provision of services (87.9%) and the capacity of the health and adult social care system to implement a new standard (86.4%) - see table 4. The least common response was to consider the impact on existing contracts (71.2%). However, this differed between groups - with IT suppliers supporting it strongly (84.2% of IT suppliers) but health or social care providers less so (64.3% of those providers).     

The following were suggested as additional considerations under the ‘other’ category:  

• clinical safety and impact on users of services
• setting realistic timescales for implementation
• interoperability and integration with existing IT systems

Table 4: In addition to seeking advice, which of the following do you think the Secretary of State or NHS England should consider before preparing an information standard? 

Response	Count	Percentage
Impact on the provision of health or adult social care services	116	87.9%
Capacity of the health and adult social care system to implement a new standard	114	86.4%
Cost of implementation	108	81.8%
The need for alignment with open or international standards	104	78.8%
Impact on existing contracts	94	71.2%

Publishing standards

Respondents were asked which of a potential list of information should be included when publishing information standards. Six of the items on that list received greater than 90% support from respondents:  

• name of standard (98.5%)
• date it was published (95.5%)
• guidance on implementation (95.5%)
• a list of changes to the standard (94.7%)
• the fact that it must be complied with (91.7%)
• the consequences of failure to comply (90.9%)

The 2 least selected options were:  

• such other information as the decision maker considers appropriate (66.7%)
• the person who prepared the standard and their contact details (63.6%)

Several free text ‘other’ responses also proposed including the purpose, benefits and rationale of the standard and stating the sectors to which the standards apply. 

Reviewing standards

The regulations may require an information standard to be reviewed periodically. In relation to a proposal for information standards to be reviewed at such intervals as considered appropriate, respondents were divided about the appropriate interval between reviews of an information standard. Review at least every 3 years was the most common of the provided answers with 37.1% selecting this option (see table 5).

Additionally, a number of the free text ‘other’ responses expressed support for review at least every 3 years, provided this could vary on a case-by-case basis and by exception where appropriate.  

Several free text answers proposed more frequent reviews following the initial publication of a standard, for example every 12 or 18 months, and then moving to a longer period such as 3 years. 

There was a high level of agreement that the regulations should specify the minimum interval for reviewing information standards with 77.3% of respondents answering yes, and 16.7% answering no. 

Table 5: What do you think would be an appropriate minimum interval for reviewing an information standard?

Option	Count	Percentage
No fixed interval - case-by-case decision	26	19.7%
Reviewed every 18 months	24	18.2%
Reviewed every 3 years	49	37.1%
Reviewed every 5 years	9	6.8%

Note: percentages do not add up to 100% as ‘other’ answers are excluded from the table.

Other procedures to be followed

Respondents were given the opportunity to suggest any other procedures that should be followed in connection with the preparation and publication of information standards. Responses broadly fell into 5 themes: 

1. Stakeholder and public involvement: responses placed significant emphasis on the importance of engaging with stakeholders, users and the public when preparing new information standards or making changes to existing ones.
2. Consequences of non-compliance: a number of responses requested a clear statement of the consequences of not adopting or complying with standards.
3. Timescales: several responses expressed that any new information standards must have a sufficient lead-in time and sufficient notice be given to providers and suppliers, to allow them to prepare for changes.
4. Minimum compliance standards: a few responses mentioned the possibility of an accepted minimum level of compliance which is less demanding than the full standard.
5. Language and accessibility: a few responses highlighted the importance of using accessible and straightforward language in preparing and publishing information standards, to reduce the risk of misinterpretation from those who apply them.

Revising information standards 

Once issued, it may be necessary to revise an information standard. Respondents were divided about which procedure should be followed in revising an information standard, with 37.9% of respondents of the view that only some revisions should go through the full procedure and 27.3% that all revisions should go through the full procedure.  

Several free text answers expressed that the level of procedure to which revision is subject should be determined on a case-by-case basis so that it is proportionate to the change and with input from stakeholders. 

The most popular option for both organisation types (IT suppliers and health and care providers) was that only some revisions should go through the full procedure.  

Health and care providers were much more likely to answer that only some revisions should go through a light touch procedure, with 16.7% of health and care providers in support of this compared with 2.6% of IT suppliers. 

When asked to specify which steps should be included in a ‘light touch’ procedure for revisions, the most frequently selected option from the list provided was ‘obtaining advice, such as from an advisory board or other persons’ (77.3%). This preference was broadly consistent across both IT suppliers and health or social care providers (81.6% versus 76.2%) - see table 6.  

There was similar agreement across both types of organisations (IT suppliers and health and social care providers) about the importance of a light touch procedure, including:

• consideration of the impact on the provision of health or adult social care services’ (71.1% by IT suppliers and 76.2% by health or social care providers)

• considering the capacity of the health or adult social care system to implement changes (76.3% by IT suppliers and 71.4% by health or social care providers)

IT suppliers favoured considering the cost of implementation (78.9%) and the impact on existing contracts (78.9%) significantly more than health or social care providers (59.5% and 50%, respectively).  

Table 6: Which steps should a ‘light-touch’ procedure for revisions to an information standard include? (Responses from IT suppliers and health or social care providers)

Option	Count health or social care provider	% health or social care provider	Count IT supplier	% IT supplier
Obtain advice, such as from an advisory board or other persons	32	76.2%	31	81.6%
Consider costs of implementation	25	59.5%	30	78.9%
Consider impact on existing contracts	21	50.0%	30	78.9%
Consider capacity of the health and adult social care system to implement changes	30	71.4%	29	76.3%
Consider impact on the provision of health or adult social care services	32	76.2%	27	71.1%
Consider alignment with open or international standards	29	69.0%	26	68.4%
Don’t know	2	4.8%	0	0.0%

Revoking information standards

Once issued, it may be necessary to revoke (withdraw) an information standard. Most respondents felt that revoking (withdrawing) an information standard should go through the full procedure, except those made in discharge of a legal obligation (57%).  

Several free text answers supported a case-by-case approach. 

Adopting information standards

It may be necessary to adopt an information standard prepared or published by another organisation or body. Most respondents felt that adopted information standards should go through the full procedure (59.8%).  

There was further support for a case-by-case approach in free text answers.