Closed consultation

Health Protection (Notification) Regulations 2010: proposed amendments

Updated 7 February 2024

Applies to England

Introduction

Legislation is a vital tool in public health protection in England. It enables local authorities and the UK Health Security Agency (UKHSA) to swiftly respond to suspected cases of infectious disease that could have an impact on public health.

The Health Protection (Notification) Regulations 2010 (HPNR) have 2 core functions. Firstly, the regulations place a statutory duty on registered medical practitioners (such as doctors) in England to notify the relevant local authority if they treat a patient they know, or suspect to be, infected or contaminated with a specific infectious disease. The current list of ‘notifiable diseases’ can be found in schedule 1 of the regulations. As part of this, the HPNR requires registered medical practitioners to notify cases of other infections or of contaminations not included in schedule 1 which they believe present, or could present, a significant risk to human health. Placing a legal duty on registered medical practitioners to report suspected cases of notifiable diseases facilitates prompt public health action and ensures that, if required, timely prevention and control measures can be put in place.

Secondly, the regulations place a statutory duty on all diagnostic laboratories that test human samples in England to notify UKHSA if they identify a notifiable causative agent. A causative agent is any virus, bacterium, fungus, parasitic agent or microorganism which is directly or indirectly responsible for causing the corresponding disease. The current list of notifiable causative agents can be found in schedule 2 of the regulations. Making certain causative agents legally notifiable strengthens surveillance capabilities for infectious diseases, which is key to detecting outbreaks and understanding outbreak progression and trends.

Ensuring that schedule 1 and schedule 2 reflect current public health needs is critical to maintaining strong surveillance systems enabling prompt investigation, risk assessment and response to cases of infectious disease that pose a significant risk to human health. A recent review by the Department of Health and Social Care (DHSC) and UKHSA proposed that 7 infectious diseases could be added to schedule 1, and 12 causative agents could be added to schedule 2 of the HPNR.

The review also recommended an expansion of the HPNR’s laboratory reporting requirements under schedule 2 to include negative and void results, in addition to reporting positive tests, which is already required. Data on negative and void tests supports the monitoring of vaccination programmes and provides information on testing rates to help understand how they may be impacting on reported incidence of disease. This requirement was introduced for SARS-CoV-2 during the pandemic, which enabled UKHSA to attain greater granularity in data for surveillance.

It is important to note that the proposed amendments include adding Treponema pallidum (syphilis) and Neisseria gonorrhoeae (gonorrhoea) to schedule 2 of the HPNR. As with the other proposed additions to schedule 1 and 2, the decision to include these diseases in the regulations will be reviewed through this consultation process. Before any final decisions are made, a full impact assessment reviewing the potential inclusion of gonorrhoea and syphilis will also be conducted. The impact assessment will be shaped by responses to this consultation and will seek the views of key stakeholders. Further detail is provided below under proposal 2.

This consultation seeks the views of relevant stakeholders on making more diseases and causative agents notifiable under the HPNR, as well as the expansion of the HPNR’s laboratory reporting requirements to strengthen disease surveillance.

Proposal 1: addition of 7 infectious diseases to schedule 1 - notifiable diseases

Following a review of the current HPNR it is proposed that the following 7 infectious diseases could be added to schedule 1 and become legally notifiable by registered medical practitioners to the ‘proper officer’ of the local authority (usually delegated to a UKHSA health protection team consultant):

1. Middle East respiratory syndrome (MERS)
2. Influenza of zoonotic origin
3. Chickenpox (varicella)
4. Congenital syphilis
5. Neonatal herpes
6. Acute flaccid paralysis or acute flaccid myelitis (AFP or AFM)
7. Disseminated gonococcal infection

Background and rationale to infectious diseases proposed for inclusion as notifiable diseases, and potential implications

1. Middle East respiratory syndrome (MERS)

MERS is a high consequence infectious disease (HCID) and a concern for public health due to the associated case fatality rate and the potential for large clusters to occur, particularly in healthcare settings. Adding MERS to schedule 1 will bring surveillance of the disease in line with other HCIDs on the HPNR, such as viral haemorrhagic fever (VHF), which is already included.

The additional reporting burden of including MERS to schedule 1 is likely to be low as there are existing reporting mechanisms in place which clinicians are encouraged to use, though they are not legally required to do so. Adding MERS to schedule 1 will provide this legal requirement, improving surveillance of the disease and better informing public health action if needed.

2. Influenza of zoonotic origin (avian influenza, swine influenza or influenza from other potential animal reservoirs)

Early identification and reporting of influenza of zoonotic origin would support the timely implementation of public health infection prevention and control measures, disease surveillance and pandemic planning. It would also allow for more rapid sharing of information with government departments, including the Animal and Plant Health Agency (APHA) and Department for Environment, Food and Rural Affairs (DEFRA), to facilitate further investigations and inform risk assessments.

Influenza can infect many different animals, including birds and mammals. There have been unprecedented numbers of birds affected by zoonotic (avian) influenza (H5N1) in recent years, and these infections are spilling over into some mammals, particularly those that scavenge on dead birds, including foxes, seals and otters. As influenza of zoonotic origin can infect humans and has the potential to result in a pandemic, the notification of any human cases of zoonotic influenza is important for public health disease control. The broad term of influenza of zoonotic origin allows for flexibility to adapt to changes in animal reservoirs identified over time (for example, to include zoonotic influenza where the source is suspected to be from bird and non-human mammals).

Diagnostic laboratories have established relationships with public health agencies in relation to data flows for reporting. These relationships have been strengthened further during the pandemic and therefore the additional reporting burden should be low.

3. Chickenpox (varicella)

There are 3 key arguments for the inclusion of chickenpox as a notifiable disease:

• to enable a prompt risk assessment and post-exposure treatment of high-risk contacts. For high risk, susceptible individuals, antivirals or varicella zoster immunoglobulin (VZIG) are recommended after exposure to chickenpox and shingles. Prompt notification of exposure could mean that VZIG and antivirals can be delivered within the recommended timeframe (within 7 days for immunosuppressed and young babies, and within 10 days for pregnant women)
• surveillance to estimate the burden of disease. Current data on the burden of disease from general practitioners (GPs) and hospital admission data may significantly underestimate case numbers. Including chickenpox as a notifiable disease could improve the accuracy on the burden of disease. This data may be able to assist the UK Joint Committee on Vaccination and Immunisation (JCVI) when analysing cost effectiveness of potential control strategies. As some chickenpox cases do not seek medical care, no source of data on chickenpox is complete. However, having different sources of data is important for triangulation and building up the overall burden. Notification to a health protection team also facilitates collection of demographic and other data, for example coinfection with group A streptococcus
• to establish baseline data to evaluate the impact of a future vaccine programme. If a childhood chickenpox vaccine programme were to be introduced, notification data could provide an early evaluation of the effectiveness of the programme. Notification offers a rapid reporting system which you need for monitoring trends when you introduce a vaccination programme, and for picking up outbreaks (where you may wish to vaccinate). As vaccination may change both the incidence and age distribution, there is often a change in the proportion of cases seeking medical care. For this reason, diseases that are vaccine-preventable are almost all notifiable even if not all cases seek medical care - for example mumps and hepatitis A

GP practices are already set up to notify health protection teams for a wide range of infectious disease. The addition of chickenpox would likely be a minimal burden for each practice, although workloads for UKHSA teams will increase. If a vaccine programme is introduced, long-term case numbers would be expected to fall.

4. Congenital syphilis

Current surveillance (including recently strengthened surveillance of infectious diseases in pregnancy) does not detect all cases of congenital syphilis. Cases are rare and dispersed and can come to notice through different routes. It is important to have complete and timely understanding of this serious and preventable condition. Including congenital syphilis under schedule 1 would improve surveillance of these rare cases to inform action to reduce the number of cases to zero.

Reporting additional cases will pose a small additional burden for medical practitioners. However, cases are rare (under 10 per year) and the overall the reporting burden will be low.

5. Neonatal herpes

There is currently a poor understanding of the burden of this condition on the population as there is not regular surveillance. Limited evidence available suggests cases are increasing. Better information is required to understand and prevent this outcome. Including neonatal herpes on schedule 1 will improve surveillance and there has been advocacy from support groups to make neonatal herpes notifiable.

Reporting cases could pose an additional burden. However, cases are uncommon (under 100 per year), and so the additional reporting burden will be low.

6. Acute flaccid paralysis or acute flaccid myelitis (AFP or AFM)

Although the UK has been certified as polio-free by the World Health Organization (WHO), to maintain this status there is a need to demonstrate that AFP and AFM cases are adequately investigated to exclude infection with poliovirus. The addition of AFP and AFM to schedule 1 will help to:

• improve our ability to find cases (and provide that evidence to the WHO) and improve appropriate and timely biological sample collection (which will in turn facilitate early detection of outbreaks and clusters)
• increase the sensitivity of the polio and non-polio enterovirus surveillance system
• improve compliance with international standards for the global polio eradication programme

In response to the ongoing national enhanced polio incident, UKHSA has issued communications to clinicians. This is to remind them of their responsibility to report and investigate AFP cases under the catch-provisions of regulation 2(1)(b) of the HPNR, which places a duty on registered medical practitioners (RMPs) to report any suspected infections that present or could present significant harm to human health. The addition of AFP and AFM to schedule 1 will simply make this an ongoing requirement and bring us in line with WHO requirements.

There may be some additional workload on health protection teams who receive AFP notifications. However, the numbers reported are small and so the burden will be low, as evidenced by the current incident response.

7. Disseminated gonococcal infection (DGI)

DGI is a rare complication of untreated gonorrhoea. It presents as fever, skin rash and joint pain, or septic arthritis. In rare cases, meningitis, endocarditis or osteomyelitis can occur. Historically it was estimated to occur in 0.5% to 3% of patients with untreated gonorrhoea but there is no recent incidence data for England - although in 2019 there were reports of increased incidence in Europe and North America.

Given that cases of gonorrhoea have tripled in a decade, with over 70,000 diagnosed every year in England and further increases likely, a significant number of DGI cases may be occurring. As treatment of DGI can take place through many different specialities, such as orthopaedics or infectious disease physicians, not necessarily through sexual health clinics, there may be gaps in surveillance data.

Making cases of DGI notifiable will increase awareness to report cases across all specialties and will in turn allow UKHSA to quantify and characterise DGI in England. This will be helpful to understand which individuals are at risk and determine whether specific public health actions are needed. The additional reporting burden for medical practitioners is likely to be low as DGI cases are rare.

Proposal 2: addition of 12 causative agents to schedule 2 - causative agents

As part of the review, UKHSA also proposed adding 12 causative agents to schedule 2. This would make it a statutory duty for all diagnostic laboratories in England to notify UKHSA if they identify any of these causative agents in a human sample.

The causative agents proposed to be added to the regulations are:

1. Middle East respiratory syndrome coronavirus (MERS-CoV)
2. Non-human influenza A subtypes
3. Norovirus
4. Echinococcus spp
5. Tick-borne encephalitis virus (TBEV)
6. Toxoplasma (congenital toxoplasmosis)
7. Trichinella spp
8. Yersinia spp
9. Respiratory syncytial virus (RSV)
10. Neisseria gonorrhoeae (from a sterile site)
11. Treponema pallidum (syphilis)
12. Neisseria gonorrhoeae (non-sterile site)

Please note that below there is a specific section relating to the possible inclusion of numbers 11 and 12 given the recognised sensitivities and additional confidentiality safeguards applied to sexually transmitted infections (STIs) whereby only depersonalised data has been collected for public health surveillance purposes.

Background to infectious diseases to be included as causative agents, rationale for inclusion and any additional burdens that may arise

1. Middle East respiratory syndrome coronavirus (MERS-CoV)

The addition of MERS-CoV to schedule 2 will act as a contingency in case a case is not notified under schedule 1 because it is not identified or suspected by a clinician. This will ensure that public health measures are still undertaken if there is a potential cluster or outbreak, with laboratory notification providing an important dataset in helping to plan public health actions.

2. Non-human influenza A subtypes

Adding non-human influenza A subtypes from potential animal reservoirs, including but not limited to avian and swine species, to schedule 2 will allow for public health follow up of human cases to identify potential sources of exposure. The current human seasonal subtypes are A(H1N1) and A(H3N2). Any non-seasonal subtypes might be of zoonotic origin and may have pandemic potential. It is therefore important for any non-seasonal subtypes of influenza A to be notified so that public health investigation and management can follow. This will also allow for more comprehensive surveillance data to be reported at a national level and improve capabilities to report under the International Health Regulations (2005). 

3. Norovirus

Norovirus is the most common gastrointestinal infection in the UK. Outbreaks have a significant impact on hospitals, social care settings and educational settings. Outbreaks contribute to winter pressures in the NHS every year. Inclusion of norovirus in schedule 2 would provide a real time indicator of changes in norovirus activity at the national level, strengthening surveillance. In addition, more timely reporting of norovirus detections could:

• identify whether it’s norovirus or another enteric virus causing an increase in viral gastroenteritis
• assess potential strain replacement events
• improve communications of potential increasing risks, allowing hospitals to implement enhanced control measures where necessary, helping to reduce winter pressures on the NHS

There is already a notifiable causative organism reporting system in place. Adding norovirus to this is expected to have a low additional reporting burden.

4. Echinococcus spp (Echinococcus granulosus and Echinococcus multilocularis)

UK-acquired cases of E.granulosus (cystic Echinococcosis) are increasing. The disease has high morbidity in humans. E.granulosis is only notified by vets routinely in condemned carcases, following routine monitoring carried out in the animal sector in the UK, through slaughterhouse and abattoir post-mortem inspections by meat hygiene inspectors. However, pathogen detection is not undertaken for imported food.

Making echinococcus spp notifiable ensures the risk of infections (particularly from E.granulosus) can be monitored. Currently, it is only tested for at 2 laboratories in England. The epidemiology of infections is poorly understood. Making it notifiable would allow for improved understanding and, where necessary, timely public health response. The overall additional reporting burden to the health system is expected to be low as cases are not common.

5. Tick-borne encephalitis virus (TBEV)

TBEV and the associated tick vector are widespread in central Europe. TBEV was detected in ticks within the UK for the first time in 2019 and serological evidence of TBEV has been detected in native deer in certain areas in the UK. There have been 2 confirmed and 2 probable locally acquired human cases in the UK to date. It is possible that this is an under-representation of the burden of disease since testing for this virus is not usually considered in patients without a relevant travel history, and assays are not locally available to clinicians.

TBEV can cause central nervous system infection and lead to neurological sequelae (damage to the central nervous system that results in cognitive, sensory or motor deficits) or death. The public health response to TBEV includes improving avoidance of tick bites in the local area, ensuring health professionals are aware of the possibility of this diagnosis so they can identify possible cases for testing, and consideration of vaccination of at-risk individuals. The reporting of cases of acute infective encephalitis where no cause is identified is incomplete, and likely results in underestimation of the burden of TBEV-associated disease.

The addition of TBEV to schedule 2 is likely to improve identification of cases through mandatory reporting of suspected cases. The identification of suspected and confirmed cases of TBEV infection will additionally strengthen the public health response to TBEV through allowing targeted surveillance in the local area of ticks, animals and potentially humans, through serosurveillance. Subsequent identification of ‘hot spots’ would improve understanding of the epidemiology and burden of disease, improve targeted advice on tick avoidance, and improve evidence on vaccination.

The diagnosis of TBEV is currently carried out at the UKHSA Rare and Imported Pathogens Laboratory (RIPL), although other large laboratories may consider introducing the test if there is a clinical demand. However, confirmation of cases at RIPL will not change if TBEV is included in schedule 2 and therefore the additional reporting burden to the health system is expected to be low.

6. Toxoplasma (congenital toxoplasmosis)

If an individual becomes infected with toxoplasmosis while pregnant, there is a risk the infection can cause miscarriage, stillbirth or birth defects after the baby is born. Where there is a clinical suspicion of toxoplasmosis in the mother, this is followed up with laboratory tests, though it is not legally required. As there is no legal requirement, it is not possible to be confident that there is a robust surveillance framework in place. Statutory notification will provide enhanced clinical and serological surveillance.

The expected reporting burden of inclusion in schedule 2 is low as cases are rare.

7. Trichinella spp

Very few cases are currently reported annually, and those which are reported are linked to imported cases or pork products. UKHSA currently monitors and reports the small number of trichinellosis cases reported annually and supports the mandatory reporting of these diagnoses.

Inclusion into schedule 2 would allow public health risks of any infection to be followed up promptly and ensure that any local foci for infection can be investigated, and other potential exposed individuals identified. This would be valuable as severe cases of the disease can be fatal. Inclusion would also help establish changing trends in the epidemiology of infections. The cases are not common, and therefore the additional reporting burden is likely to be low.

8. Yersinia spp

Yersiniosis is an emerging infection with a significant increase in reported cases in the UK in recent years. A lack of specific clinical symptoms makes it unsuitable for schedule 1. Inclusion of the disease in schedule 2, combined with routine testing in patients presenting with gastroenteritis and sepsis, will improve detection of foodborne outbreaks of yersiniosis. It could also reduce the burden of long-term sequelae (chronic complications following initial acute illness) due to an improved ability to implement public health protection action.

Although there are existing reporting mechanisms in place in laboratories, there are currently a significant number of cases of gastrointestinal yersiniosis being noted and so, at least in the short term, an increase in reporting burden is likely if yersinia spp is made notifiable.

9. Respiratory syncytial virus (RSV)

RSV exhibits regional variation in the time of cases peaking and the burden of disease. Including RSV in schedule 2 would strengthen sub-national surveillance and regional health system responses. Similarly, the evidence could be used to inform vaccination or immunisation programmes, or changes to the current targeted RSV programme. In addition, the introduction of negative and null reporting (proposal 3, set out in the next section) from RSV tests would particularly add value for determination of disease trends, disease burden assessment and evaluation of public health interventions, such as immunisation programmes.

10. Neisseria gonorrhoeae (from a sterile site)

Adding Neisseria gonorrhoeae (from a sterile site) will allow confirmed cases of DGI to be followed up. This will help to inform patient management, update guidance and determine whether specific public health actions are needed.

11 and 12. Treponema pallidum (syphilis) and Neisseria gonorrhoeae (gonorrhoea) (non-sterile site)

The proposal to include these 2 infections in schedule 2 requires more in-depth consideration through this consultation and a further impact assessment. Please consider the below and any other topics you may want to be reviewed when responding to the consultation questions.

It is important to make clear that while these 2 infections have been listed alongside other proposed additions, their inclusion will be guided by responses to this consultation and the following impact assessment. The impact assessment will focus solely on the inclusion of these 2 infections, will be shaped by consultation responses and engagement with key stakeholders.

Considerations around making syphilis and gonorrhoea legally notifiable under schedule 2

Confidentiality:

• there are additional levels of confidentiality afforded to patients in relation to STI testing. This is an important part of sexual health services and the inclusion of these infections in schedule 2 raises concerns around an individual’s control over anonymity. Under schedule 2, when a laboratory reports a test result to UKHSA they must include the person’s name, sex, current address and other personal details. Protecting an individual’s right to confidentiality is vital and access to data collected through the HPNR is strictly controlled and only seen by those with a clear need

Surveillance and testing systems:

• diagnoses and management of individuals diagnosed with syphilis and gonorrhoea is undertaken in multiple settings, including sexual health clinics. These systems are well established and high quality, and they provide a full service of testing, treatment and partner notification
• in addition, sexual health services report all syphilis and gonorrhoea diagnoses to UKHSA through the GUMCAD STI Surveillance system. UKHSA has detailed, pseudonymised data for the vast majority of test results for these infections. For instance, an estimated 96% of gonorrhoea diagnoses are detected through GUMCAD and this figure is likely to be at least this high for syphilis. Furthermore, gonorrhoea specimens with concerning antimicrobial resistance profiles are submitted to the National Reference Laboratory at UKHSA for investigation and follow up
• UKHSA has mandatory, established, high-quality surveillance systems to monitor these STIs through sexual health services and publicly funded online STI testing services. However, there may be a case for future-proofing this reporting to account for an increasing proportion of cases being diagnosed outside of these settings

Effective public health response to increased diagnoses and outbreaks:

• cases of syphilis are increasing in all areas with historically high numbers of new diagnoses being made. This can subsequently lead to increases in late complications of untreated infections. Similarly, gonorrhoea rates have increased over the past decade to high levels. It is now the second most diagnosed STI in the UK. There are concerns that strains with antimicrobial resistance (AMR) could spread rapidly before being detected, making it harder to control
• the increased diagnoses of these infections coupled with considerations for future-proofing testing surveillance, and monitoring complications requiring follow up treatment, might mean it is no longer sufficient to rely solely on the current systems of reporting. In which case, adding gonorrhoea and syphilis to schedule 2 may support the public health response by improving surveillance of the infections and informing more effective public health action
• for syphilis and gonorrhoea, any potential improvement in surveillance would also improve health practitioners’ ability to see the future needs of the population and understand impacts of factors such as ageing. This may again inform more effective public health interventions

Syphilis and gonorrhoea are already currently listed as core pathogens for voluntary reporting to UKHSA surveillance systems. They are already reported as pseudonymised, depersonalised data by some laboratories, with data used to provide an early indication of overall trends. As there are existing reporting channels, if any were to be added to schedule 2, the additional reporting burden is expected to be low.

Proposal 3: amendments to reporting requirements

Under the existing HPNR, diagnostic laboratories are only legally required to report positive test results for causative agents under schedule 2.

The third proposal of this consultation is to explore the recommendation for all diagnostic laboratories in England testing human samples to be required to report positive, negative and void test results for all causative agents under schedule 2.

During the pandemic, COVID-19 was added to schedule 1 and SARS-CoV-2 to schedule 2. Further amendments were made to place a legal duty on all diagnostic laboratories testing human samples to notify UKHSA of negative and void test results, as well as positive results, for the detection of SARS-CoV-2 or influenza virus. This additional level of reporting allows for a number of improvements, including:

• better understanding of testing trends. For example, signalling when an apparent increase in disease is actually being caused by an increase in testing
• better evaluation of vaccine programmes. It allows an improved assessment of vaccine effectiveness and monitoring of vaccination programmes. Information on who doesn’t have a disease is critical for knowing how well a vaccine works. The UK has been world-leading in evaluating COVID-19 vaccines because this negative and void testing feature was introduced during the pandemic
• better understanding of disparities in healthcare access. It would be easier to determine who is accessing testing, improving efforts to tackle disparities in access or healthcare diagnostic testing
• better understanding of whether recommendations and guidelines are being followed. In addition, it would allow optimisation of communication and targeting of diagnostic tests to the individuals who need them
• improved understanding of healthcare utilisation resources required for pathology testing. This can be used to determine the optimal pathology services and resourcing for the future

In addition, expanding laboratory reporting requirements to now include negative and void test results will strengthen surveillance preparedness and help prevent the need to make adjustments to laboratory and reporting systems during the response to a potential health threat.

There will likely be an increase in the reporting burden in the short term as laboratories readjust to new reporting requirements. This would then taper off as the system readjusts.

Outside the scope of this consultation

All devolved administrations have programmes of work to consider how to align the infectious disease notification regulations alongside the UK-wide requirements contained within the Health Security (EU Exit) Regulations.

How to respond

This consultation is open from 12 July to 15 November 2023. Please submit your response to the questions by 11:59pm on 15 November 2023.

The deadline for this consultation was extended from 4 October 2023 to 15 November 2023.

You can respond to this consultation through our online survey.

If you have any queries about this consultation or require an alternative format please contact hpnrconsultation@dhsc.gov.uk.

What happens next

The consultation will close at 11.59pm on 15 November 2023. Responses received on or before this date will be carefully considered. Any policy decisions on the future strategy will be taken only after full consideration is given to consultation responses, submitted evidence and other relevant information.

Consultation questions

To what extent do you agree or disagree that schedule 1 and schedule 2 of the Health Protection (Notification) Regulations should be updated at this time?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Please explain your answer (maximum 250 words).

To what extent do you agree or disagree with the proposal to add at least one of the 7 diseases listed to schedule 1?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Please select the diseases that you think should be added to schedule 1, from the list of 7 diseases.

Please explain why (maximum 250 words).

To what extent do you agree or disagree that the proposed additions to schedule 1 will not significantly increase workload of registered medical practitioners?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Please provide further comments if you wish (maximum 250 words).

To what extent do you agree or disagree with the proposal to add at least one of the 12 causative agents listed to schedule 2?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Please select the causative agents that you think should be added to schedule 2 (from the list of 12 causative agents).

Please explain why (maximum 250 words).

If you do not agree with any of the additions listed, please explain why (maximum 250 words).

To what extent do you agree or disagree that the proposed additions to schedule 2 will not significantly increase workload of registered medical practitioners?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Please provide further comments if you wish (maximum 250 words).

To what extent do you agree or disagree that including syphilis and gonorrhoea in schedule 2 would be beneficial for patients and effective public health interventions?

• strongly agree
• slightly agree
• neither agree nor disagree
• slightly disagree
• strongly disagree

Please explain your answer. Include what, if any, potential impacts, positive or negative you think could result from their inclusion (maximum 250 words).

What would you like to see covered as part of the impact assessment on the proposed inclusion of syphilis and gonorrhoea in schedule 2? (maximum 250 words).

To what extent do you agree or disagree with the proposal to amend schedule 2 to require diagnostic laboratories to report void and negative test results?

• strongly agree
• agree
• neither agree nor disagree
• slightly disagree
• strongly disagree

Please provide further comments if you wish (maximum 250 words).

What difference do you think the requirement for diagnostic laboratories to report void and negative test results in addition to positive results (as is already required) will have on workload?

• no increase in workload
• small increase in workload
• significant increase in workload
• not sure

Please provide further comments if you wish (maximum 250 words).

Are there any other diseases or causative agents that should be considered for addition to schedule 1 or 2?

Please explain your answer (maximum 250 words).

Impact assessment

An impact assessment will be conducted following the results of this consultation. It will explore the potential impacts of including syphilis and gonorrhoea in schedule 2 and will be shaped by responses to this consultation and will seek to engage a full range of stakeholders. Results from this consultation, impact assessment and any further suggestions will be shared following the analysis of all feedback.

Privacy notice

Summary of initiative and/or policy

The Department of Health and Social Care (the department) proposes to update the Health Protection (Notification) Regulations 2010 by adding 7 diseases to schedule 1 (notifiable diseases), adding 12 causative agents to schedule 2 (causative agents) and amending diagnostic laboratories reporting requirements in England to include negative and void results as well as positive results which are already required.

Data controller

The Department of Health and Social Care is the data controller.

What personal data we collect

We will be collecting information in relation to the following:

• the individual’s name
• the individual’s age
• the individual’s sex
• the individual’s gender
• the capacity in which a person is responding to the survey. That is, if the respondent is sharing their professional views or responding on behalf of an organisation
• if the person is responding on behalf of an organisation, we collect information on the type of organisation they are responding for (for example, whether it is a business or academic institution), what the name of the organisation is and where the organisation operates (for example, England or Wales)
• the individual or organisation’s email address. It will not be mandatory to provide this information to respond to the policy questions in the consultation

How we use your data (purposes)

We will collect personal information for the online survey form for this consultation. If you write to or email us directly then we will collect your personal information via this channel.

We need to hold your information to understand in what capacity you are responding as this is crucial in our analysis of how our proposals will affect different individuals and organisations.

We ask you to provide your age, sex and gender to understand the diversity of responses that we receive to the consultation. This information will be collated separately from the responses.

We ask you to provide your email address for the following reasons:

• if you need to contact us about amending or deleting your response, the only way we can verify that it is your response is via your email address
• if our policy team have a follow-up question to ask you, we can contact you

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Under Article 6 of the United Kingdom General Data Protection Regulation (UK GDPR), the lawful bases we rely on for processing this information are:

(e) Public task (necessary to perform a task in the public interest or in the exercise of our official functions): for the processing of all other personal data

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Personal data will only be shared internally within DHSC with employees involved in this consultation.

International data transfers and storage locations

All data is stored on DHSC secured platforms.

Retention and disposal policy

Personal information collected will be held for a period of 12 months following the close of the consultation.

How we keep your data secure

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Your rights as a data subject

By law, data subjects have a number of rights and this processing does not take away or reduce these rights under the EU General Data Protection Regulation (2016/679) and the UK Data Protection Act 2018 applies.

These rights are:

• the right to get copies of information - individuals have the right to ask for a copy of any information about them that is used
• the right to get information corrected - individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected
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• the right to object to the information being used - individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case
• the right to get information deleted - this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme should contact data_protection@dhsc.gov.uk in the first instance, or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioners Office. Their website address is www.ico.org.uk and their postal address is:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision-making or profiling

No decision will be made about individuals solely based on automated decision-making (where a decision is taken about them using an electronic system without human involvement) which has a significant impact on them.

Changes to this policy

This privacy notice is kept under regular review, and new versions will be available on our privacy notice page on our website. This privacy notice was last updated on 12 July 2023.