The Health Protection (Coronavirus) (Requirements) (Scotland) Amendment Regulations 2022 and The Health Protection (Coronavirus) (Requirements) (Scotland) Amendment (No. 2) Regulations 2022: business and regulatory impact assessment

Introduction

This Business and Regulatory Impact Assessment considers the impacts for businesses and consumers of amending the definition of fully vaccinated to include the requirement for a booster vaccination if a person's primary course of MHRA vaccine was more than 120 days ago and amending the definition of late night venue. The scheme will continue to accept a record of a negative test (either lateral flow device (LFD) or polymerase chain reaction (PCR)) as an alternative to proof of vaccination in order to access those settings.

Where there are potential negative impacts, mitigating actions where appropriate have been identified. The use of Covid Status Certification for international travel is beyond the scope of this impact assessment. The Scottish Government's Framework for Decision Making recognises that harms caused by the pandemic do not impact everyone equally.

Policy proposal

Covid Status Certification requires certain premises and events to ensure that there is a reasonable system in operation for establishing that all people in the premises can demonstrate that they are fully vaccinated, they have received a negative test result (LFD or PCR), or they are exempt and to refuse access to or remove anyone who is neither fully vaccinated, nor has received a negative test result, nor is exempt. To be considered fully vaccinated, you must have completed a course of an authorised MHRA vaccine with the final dose having been received at least 2 weeks previously. If 120 days have passed since the primary course was completed you must have had a booster dose plus 10 days (this is to ensure that the vaccine has taken effect). A negative test result means that a person has received a negative Lateral Flow Device test (LFD) or Polymerase Chain Reaction (PCR) test in the last 24 hours.

The settings covered in the original scheme on 1 October include:

• Certain late night premises with music, which serve alcohol after midnight and have a dancefloor or space where dancing by customers take place
• indoor events (unseated) planned for 500 or more people at any one time
• outdoor events (unseated) planned for 4,000 or more people at any one time
• any event planned for 10,000 or more people at any one time.

Based on evidence and a balance of the four harms^[1] of the virus, the regulations were subsequently amended on 6 December to include a negative test result (either a lateral flow device (LFD) or polymerase chain reaction (PCR) from within the last 24 hours, as an alternative to proof of vaccination to gain entry to the settings in scope. Initially, the scheme – introduced on 1^st October - did not include a negative test result as an alternative to proof of vaccination as we did not consider that it would be appropriate and believed it could undermine one of the policy aims of the scheme: to increase vaccine uptake. This new provision came into effect on 6 December.

This change made it possible for more people to make use of the scheme, such as those who are not yet fully vaccinated. It also means that individuals who received a vaccine not recognised by the MHRA, or who have experienced difficulty accessing their vaccination record, will be able to attend venues covered by the scheme. We hope that the inclusion of testing will encourage the greater use of regular testing and will still support us to achieve our policy objective of reducing the risk of transmission of Coronavirus.

Ministers have been clear that Covid Status Certification will not be a requirement for public services or other settings that many people have no option but to attend, such as public transport, health services and education.

The following do not qualify as events for the purposes of the scheme:

• a funeral, marriage ceremony, civil partnership registration, or a reception or gathering which relates to a funeral, marriage ceremony or civil partnership registration
• a mass participation event such as a marathon, triathlon or charity walk
• an event designated by the Scottish Ministers as a flagship event according to criteria, and in a list published by the Scottish Ministers
• a drive-in event
• an organised picket
• a protest or demonstration
• a public or street market
• an illuminated trail
• a work or business conference (not including any peripheral reception or function outside the core hours of the conference, whether or not alcohol is served)
• a business or trade event which is not open to the public for leisure purposes
• communal religious worship
• an un-ticketed event held at an outdoor public place with no fixed entry points.

The following people are exempt:

• under 18s
• people who for medical reasons cannot be fully vaccinated and cannot undertake a qualifying COVID-19 test
• people taking part (or who have taken part) in vaccine trials
• the person responsible for the premises
• workers and volunteers at the premises or event
• emergency services responders and regulators carrying out their work

The regulations require the persons responsible for a setting to ensure there is a reasonable system in operation for checking that people seeking to enter the premises are fully vaccinated, can provide record of a negative test result (either LFD or PCR), or are exempt, and to have in place a compliance plan for the system.

The amendments to the scheme will come into force on 17 and 24 January 2022. Ministers must review the Health Protection (Coronavirus) (Requirements) (Scotland) Regulations 2021 (which include Certification) at least every 3 weeks to assess whether any requirement in the regulations is still necessary to prevent, protect against or provide a public health response to the incidence or spread of infection in Scotland. We will continue to assess whether any less intrusive measures could be introduced to achieve the same combination of policy objectives in respect of the higher risk sectors concerned; if so, the policy will be immediately reviewed.

Sectoral Guidance is published on the Scottish Government website. Guidance for the wider public is published on the Scottish Government website.

Policy Objectives

In line with our strategic intent to 'suppress the virus to a level consistent with alleviating its harms while we recover and rebuild for a better future', the policy objectives of Covid Certification remain to:

• Reduce the risk of transmission of Coronavirus, by ensuring that specified public spaces where transmission risks are higher are used only by those who are fully vaccinated including a booster when required, can provide a record of a negative test within the previous 24 hours, or are exempt. Vaccination or a negative test within the previous 24 hours reduces (but does not eliminate) the risk of being infected, the risk of serious illness and death if they are infected and the risk of infecting others; Reduce the risk of serious illness and death thereby alleviating current and future pressure on the National Health Service, by reducing transmission in specified settings where transmission risks are higher;
• Reduce the risk of settings specified in the scheme being required to operate under more restrictive protections, or to close, by ensuring that the risk of transmission in these settings is reduced; and
• Increase the protection enjoyed by those using settings covered by the scheme and their contacts, by incentivising those using the settings to take up the vaccine and/or to test regularly and self-isolate if positive.

An evidence paper summarising the range of evidence available on certification schemes was published. Consistent with our approach throughout the pandemic, the paper adopts a four harms approach covering the direct health harms of Covid-19, the indirect health harms, the social and the economic harms. Evidence is drawn from clinical and scientific literature, from public opinion and from international experience. A follow-up evidence paper which sets out the evidence on certification schemes since the original paper was published. An evidence paper on the Omicron variant was published on 10 December 2021. This impact assessment should also be considered alongside the latest State of the Epidemic report.

Public health rationale

The COVID-19 epidemic continues to pose considerable challenges. After decreasing in November 2021, new case rates rose sharply from the end of December and peaked in early January 2022. The 7 day positive PCR case rates per 100,000 are currently averaging around under a 1,000 per day (based on PCR tests only). However, it should be noted that on 5 January 2022, the Scottish Government announced that people who do not have symptoms of Covid-19 will no longer be asked to take a polymerase chain reaction (PCR) test to confirm a positive Lateral Flow Device (LFD) result. Instead, anyone with a positive LFD, who does not have symptoms, should report the result online as soon as the test is done. This means that those without symptoms who previously would have taken a confirmatory PCR test, will no longer do so. As a result, these positive cases are not directly comparable with previously reported number of cases. Weekly hospital admissions with confirmed COVID-19 have started to decrease over the last week. Case rates and age standardised hospital admissions are considerably lower in vaccinated versus unvaccinated individuals. Modelling indicates uncertainty over hospital occupancy and intensive care in the next four weeks. Hospitals are currently at, or very close to, capacity and have been in this position for many weeks now with several Health Boards operating within an environment of unprecedented pressure and heightened risk, plus a requirement for military support. This is likely to be driven by Covid-19 cases and delayed discharges but also may reflect that patients with higher acuity are now requiring admission.

Omicron is now the dominant variant across the UK^[2]. Risk assessments on Omicron (B.1.1.529) have been published by the UK Health Security Agency (UKHSA).^[3] The growth advantage has been designated as red, with a high confidence, indicating that Omicron has a significant growth advantage over Delta, with greater household transmission risk and secondary attack rate being seen. ^{[4] [5]} There is high confidence that immune evasion is a substantial contributor to the growth advantage but it is also biologically plausible that increased transmissibility of the omicron variant is also contributing.

Therefore, the transmissibility of Omicron has been designated as amber with a low confidence by the UKHSA indicating that that Omicron is at least as transmissible as Delta but further analysis is required.^[6] There is also evidence of widespread community transmission of Omicron.^{[7] [8]}

Immune evasion to both natural and vaccine derived immunity has been designated as red with a high confidence by the UKHSA indicating that there is evidence of frequent infection in humans with known prior infection or vaccination^[9]. Neutralisation data, real world vaccine effectiveness against symptomatic disease, and reinfection rate all confirm substantial immune evasion properties^{[10] [11]}.

Infection severity has been designated as green with high confidence by the UKHSA meaning there is evidence to support a moderate reduction in the relative risk of hospitalisation compared to Delta, ranging from 15 to 80%^{[12] [13]}. The data published by UKHSA indicate that the risk of attending hospital or emergency care is around half that of Delta and the risk of being admitted from emergency care around is around one third of Delta^[14]. SAGE 102 minutes identify a potential reduction of 35-65% for the risk of hospitalisation compared to Delta^[15]. The reduction in infection severity is likely to be partly due to the nature of the variant and partly due to protection from prior infection; however, the relative contributions of the two factors has not been quantified^[16]. Early data from COVID-19 Clinical Information Network (CO-CIN) considered by SAGE on 7 January 2022 indicate that the severity of disease being observed in hospital over the last three weeks is lower than observed in early phases of previous waves, with less need for oxygen, less admission to intensive care, better outcomes, and shorter stays^[17]. From the SAGE 101 meeting on 23 December 2021, UKHSA data suggests a doubling time of 4 to 5 days for hospitalisations^[18].

Infection severity in children has been designated as amber with a low confidence as, although there has been an increase in hospital admissions, further analysis is required to compare the risk of hospitalisation between Omicron and Delta, and to assess the clinical nature of the illness in children ^[19]

The Scientific Pandemic Influenza Group on Modelling, Operational sub-group (SPI-M-O) concluded that "If omicron in the UK combines increased transmissibility and immune escape, irrespective of severity, it is highly likely that very stringent measures would be required to control growth and keep R below 1"^[20].

Our primary and secondary health and social care services are facing arguably the most significant and increasing pressures and demands in the history of the NHS. The winter period is also posing significant challenges of increased transmission and related pressure on the National Health Service. We remain of the view that action is therefore needed across all sectors to ensure adherence to baseline measures. Drawing on the evidence so far available, we consider that Covid Status Certification has an important role to play as one such measure including as a precautionary measure in light of the new Omicron variant.

Vaccination

While no vaccine is 100% effective at preventing infection, disease and transmission, and they do not completely break the link between a high volume of positive cases and serious pressure on healthcare services, they are our best route out of the pandemic. Vaccines help prevent transmission of the virus as vaccinated people are less likely to become infected and ill than unvaccinated people (and only infected people can transmit the virus). The UK Vaccine Effectiveness Expert Panel (VEEP) is a group of scientific and analytical specialists from academia and government in the UK who provide a consensus view on vaccine effectiveness, split by variant, vaccine and dose. They have published estimates for vaccine effectiveness based on an assessment of the evidence at the time of writing and as new evidence or data emerges, SAGE will update its advice. The most recent summary, published on 24^th September 2021.

Vaccine effectiveness against symptomatic disease with the Omicron variant is lower compared to the Delta variant and wanes rapidly. However, boosting returns it to a comparable level^[21]. Vaccine effectiveness 2 to 4 weeks after a booster dose ranged from around 65 to 75% for Omicron compared to >90% for Delta. Vaccine effectiveness against symptomatic disease drops to 55 to 70% at 5 to 9 weeks after a booster and a further drop to 40 to 50% from 10+ weeks after the booster for Omicron, whereas vaccine effectiveness for Delta remains over 80% at 10 weeks^{[22] [23]}.

Protection against hospitalisation from vaccination is much greater than that against symptomatic disease, in particular after a booster dose^[24]. Vaccine effectiveness against hospitalisations 4 weeks after dose 1 is at 58%, between 2-24 weeks after dose 2 at 64% and for 25+ weeks after dose 2 at 44%. Data released by UKHSA suggest that 2 to 4 weeks after a booster, vaccine effectiveness increases to 92%, after 5-9 weeks drops to 88% and that at 10+ weeks after booster, vaccine effective against hospitalisation remains at 83%^[25]

Early data considered by SAGE suggest that the probability of needing admission to ICU is very much higher in the unvaccinated population for the Omicron variant^[26]. There is currently insufficient data to make an assessment of vaccine effectiveness against severe disease for Omicron compared to Delta^[27]. However, though waning has been seen in vaccine effectiveness, it is thought that vaccine effectiveness against severe disease is more likely to be sustained, especially after a booster dose ^{[28] .} More analysis can be found in a number of large studies including EAVE-II (Early Pandemic Evaluation and Enhanced Surveillance of Covid-19) in Scotland^[29], Real-time Assessment of Community Transmission (REACT-1) in England^[30] and the Office for National Statistics (ONS) Covid-19 Infection Survey ONS study.^[31] Therefore, we have strong evidence that vaccines are effective at preventing disease, hospitalisations and deaths.

As of 18 January 2022, 85.5% of the eligible population (12+) received two doses of the vaccine and 67.2% (12+) received a booster or third dose. In the week 1 to 7 January 14.2% of positive cases were in unvaccinated individuals. In the week 1 - 7 January in an age-standardised population, individuals were 4 times more likely to be in hospital with COVID-19 if they were unvaccinated compared to individuals that had received a booster or third dose of vaccine^[32].

Vaccine uptake has progressed extremely well in the Scottish adult population with approximately 80.5% of 18 to 29 year olds and 81.8% of 16 to 17 year olds having received the first dose of the vaccine as of 18 January. At least 95% of people aged 50 and over have received two doses, but uptake of a second dose remains lower in people in their 30s (79.8%) and the 18-29 age group (72.2%) as of 18 January. Vaccine uptake has slightly increased since the scheme was announced, although it is not possible to directly attribute rises to the introduction of the Covid Status Certification. The proportion of those aged 12+ with a first dose rose to 91.8%, second dose rose to 85.5%, and a third dose or booster rose to 67.2% up to 18 January 2022^[33].

Protection due to previous infection

There is limited evidence for Omicron on the duration of natural immunity due to the high levels of vaccination within the population. However, high levels of immune escape have been seen as well as a marked increase in overall reinfection rates^{[34] [35] [36]}.

Data published on 17 November, pre Omicron, showed that those who have had a COVID-19 infection previously continue to be less likely to test positive than those who had not, with estimated likelihood of testing positive similar to those who received three doses of COVID-19 vaccine more than 14 days ago and those who received two doses of Pfizer/BioNTech vaccine between 15 to 90 days ago. Those who had previous infection were 1/5th less likely to test positive for covid compared to those who had not.^[37]

Data from numerous studies pre-Omicron indicate that neutralising antibodies last from 5-7 months^[38] for up to a year^[39] after SARS-CoV-2 infection. Individuals with severe illness produce more antibodies^[40] and vaccination of individuals who have already been infected induces higher levels of protection than following infection alone.^{[41] [42]} Young people tend to have a stronger antibody based on immunity to SAR-CoV-2 that lasts longer. A UK based study focusing on prevalence of antibody positivity to SARS-CoV-2 after first peak of infections showed that the highest prevalence and smallest overall decline in positivity was in the youngest age group (18-24 years), and lowest prevalence and largest decline in the oldest group (>74 years).^[43]

In summary it is difficult to say definitively how long natural (post-infection) immunity will last. A NERVTAG paper (New and Emerging Respiratory Virus Threats Advisory Group) presented to Scientific Advisory Group for Emergencies (SAGE) on 27 May discussed that protection from re-infection with SARS-CoV-2 can last at least 7 months and in some studies up to one year.^[44]

Testing

Two main testing methods exist for detection of SARS-CoV-2: LFDs or PCR. PCR is the recommended testing method if you have COVID-19 symptoms while LFDs are recommended only for people who do not have symptoms.^[45] PCR is a highly sensitive and specific technique to detect SARS-CoV-2 and is a recommended diagnostic testing method by the World Health Organisation (the WHO)^[46]. Specificity and sensitivity levels of >95% have been reported by SAGE for PCR testing^[47].

LFD testing is effective at identifying people with the virus when they are at their most infectious and have high viral loads.^[48] A peer-reviewed study on sensitivity of the LFDs carried out by University College London found that LFDs are more than 80% effective at detecting any level of COVID-19 infection and, therefore, can be an effective tool in reducing transmission.^[49] Another study showed that LFDs are 95% effective and 89.1% specific at detecting COVID-19 when used at the onset of symptoms.^[50] A review on the diagnostic accuracy of point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection concluded that LFDs which pass the criteria for use (e.g. WHO's priority target product profiles for COVID‐19 diagnostics) can be considered as a replacement for PCR .

Data from the Assessment of Transmission and Contagiousness of COVID-19 in Contacts (ATTACCC) study show that false negative LFD test results mostly occurred 1 to 2 days prior to peak viral load and became negative at approximately the same time as viral culture became negative^[51]. This indicates that LFDs are effective at detecting infectious cases. All the LFDs in use in the National Testing System have been shown by the British Government's Science Park, Porton Down, and University of Oxford SARS-CoV-2 lateral flow antigen test validation cell to be effective in detecting the Omicron Variant of Concern^[52].

SAGE endorsed the benefits that rapid antigen testing (such as LFD testing) could have on reducing transmission when discussing the UK Government Plan B options: "Other measures are available which, if introduced, could also make Plan B (or more stringent measures) less likely (and could potentially offer better efficiency or effectiveness) for example encouraging wider use of rapid antigen testing in workplaces and the community, and ensuring self-isolation of those who test positive by providing sufficient support".^[53]

The Scottish Government recommends to take regular lateral flow tests - especially before mixing with other people or visiting a hospital or care home, regardless of vaccine status or recent periods of infection. This will almost always identify Covid during early stages of infection and thus significantly reduce disease transmission^[54]. The optimal testing strategy in order to gain access to a high risk setting would be to take the test as close as practically possible to the time of entry. LFDs are less sensitive than PCR but have the advantage of providing rapid results, and SAGE has endorsed the benefits that rapid antigen testing (such as LFDs) could have on reducing transmission.

Customers can display an SMS (text), email or a paper printed copy showing they have registered a record of a negative test. There is no QR code within SMS or emails and so they do not need to be scanned by the NHS Scotland Covid Check App. Venues will instead perform a visual check and no data will be retained. Individuals can get an SMS or email by registering the result of their negative LFD test on the GOV.UK website, and opting in to receive notification of their result. If individuals undertake a PCR test they will automatically receive an SMS or email with the results.

The testing option requires people to have access to a standard mobile phone, mobile device or computer with an email address and access to a printer. This does not need to be a 'smart phone' and can be any mobile phone or tablet that can receive text messages or has access to email. Test results can be displayed on a mobile phone, tablet or other device, or a paper copy can be printed using a home printer or using a service which provides printing facilities, such as a public library.

For those unable to test themselves, self-test LFD kits can be administered by others (such as a family member, friend, or carer) who can also register the result on behalf of the person they tested if they are also unable to do so. For those unable to display their test results (such as people who do not have a mobile phone) when registering their result they could have it sent to another person's phone, who could then show the result on their behalf.

Settings

Higher-risk settings tend to have the following characteristics: close proximity with people from other households; settings where individuals stay for prolonged periods of time; high frequency of contacts; confined shared environments, and poor ventilation.^{[55] [56]} These settings are considered higher risk due to the way COVID-19 spreads. COVID-19 spreads in small liquid particles when an infected individual coughs, sneezes, speaks, or breathes.^[57] These droplets are able to remain suspended in the air. When people are close together or in a confined, unventilated space, it is more likely these droplets will enter another person, either through inhalation, the droplets coming into contact with their eyes, nose or mouth, or by touching an infected surface and then touching their eyes, nose or mouth. ^[58] When people meet who do not regularly see each other or have a high frequency of contacts, it is more likely one of the individuals is asymptomatically infected through their separate social groups as the total number of extended contacts is greater. Examples of settings identified by SPI-B as high risk include public transport; places of worship, shops, malls and markets; parties; cinemas; theatres; planes; large family gatherings; cultural, sporting and political events; crowds; pubs and clubs; restaurants and cafes; hotels, cruise ships, hospitals and care homes.^[59]

The Virus Watch Community Cohort Study found that during a period of no restrictions (September – November 2021), hospitality was associated with an increased risk indoors but not outdoors. Participating in sports indoors or outdoors was also associated with increased risk (although it was noted that this may relate to associated social activities). It was found that there was no good evidence of increased risk from attending cinemas, theatres, concerts, indoor sports events or for beauty services^[60]. Evidence from Germany has found that regular cinema ventilation is sufficient to minimise the risk of COVID-19 infection^[61]. However, studies have shown that intoxication has the potential to increase the risk of transmission of COVID-19 due to a decrease in compliance with increasing levels of intoxication, notably a reduction in physical distancing, lack of face masks when not seated and mixing with groups at other tables^[62]. In addition, modelled research by the Tony Blair Institute for Global Change reported that, if the NHS COVID pass had been made mandatory for crowded indoor and mass attendance settings (including sports matches, large outdoor events, indoor performances and nightclubs) in England after the lifting of restrictions on 19 July 2021, cases and deaths over the subsequent weeks could have been reduced by as much as 30%^[63].

By restricting access to customers who are fully vaccinated and/or who can provide a record of a negative test, it is less likely that infection will take place in these settings, and it is less likely that infections within them will lead to illness. Additionally, vaccination, boosters and regular testing will continue to be incentivised.

Consequently, we can reduce the risk of transmission of the virus and help reduce pressure on health services, while also allowing settings to operate as an alternative to closure or more restrictive measures. As such, we consider the Covid Status Certification, as part of a package of measures such as improved ventilation, to be a necessary and proportionate public health measure.

NHS Scotland Covid App and Paper Certificate

On 30 September we launched the NHS Scotland Covid Status App (the "App") for international use. This contains two unique QR codes, one for each dose of the vaccine and since 13 January has included booster doses. This product has been designed for use for international travel and domestic use. To meet international travel requirements it is necessary to include full name, date of birth and details of vaccination to meet EU standards.

This version of the App can be used to demonstrate vaccine status in the settings in scope.

On 20 October, the NHS Scotland Covid Check App, which is used by venues to check QR codes, was updated so that when an international QR code is scanned for domestic purposes only, a green tick or 'Certificate not valid' representing someone's vaccination status is displayed, rather than a person's name, date of birth and vaccination details.

In order to further minimise data display, on 21 October, the Covid Status App was updated to include a domestic page. This option simply shows the person's name and a QR code. When the QR code is scanned by the NHS Scotland Covid Check App it shows either a green tick or 'Certificate not valid' representing someone's vaccination status. The domestic App has functionality to hide or display a person's name. The Privacy Notice can be found on NHS Inform: Personal information we process, How we use your data, Your Rights.

On 13 January the NHS Scotland Covid Status App was updated to reflect the Scottish Government's new definition of fully vaccinated. This means that anyone who has not received the booster dose within 120 days (four months) of completing their primary course will no longer be deemed to be fully vaccinated.

Further development work will be required to update further information such as LFD negative test status in a future release of the App. In the meantime, customers can display an SMS (text) or email which records they have received a negative test. There is no QR code within SMS or emails and so they do not need to be scanned by the NHS Scotland Covid Check App. Venues will instead perform a visual check and no data will be retained. Individuals can get an SMS or email by registering the result of their LFD test on the GOV.UK website.

The latest PHS report^[64], published on Wednesday 19 January showed that, as of midnight 15 January 2022, the NHS Covid Status App has been downloaded 2,431,409 times. It is important to note a single user may choose to download the App on multiple devices, so this figure does not represent unique individuals. Between 03 September 2021 (introduction of QR codes) and midnight 15 January 2022, 715,974 paper copies of COVID-19 Status have been requested. This may not represent unique users if an individual requests a second copy (for example if they have lost their paper copy or needed to order a new one to refresh the QR codes after these have been updated). 1,736,949 PDF versions of COVID-19 Status have been downloaded. This provides a measure of the total number of times a new QR code has been generated via PDF. An individual can generate more than one successful QR code so the figure does not represent unique users. We continue to monitor user activity closely.

For those who do not have digital access or would prefer a paper copy, a record of vaccination can still be requested by phoning the Covid-19 Status Helpline on 0808 196 8565. The paper record of vaccination will then be posted to the address that is held on the National Vaccination Service System (NVSS).

When registering an account on the App the user needs to verify their identity. This is for privacy protectionas health data is special category data and protected by GDPR and human rights legislation and so additional safeguards and security measures are required to verify a person's identity before they are given access to their health records. The App uses biometric verification software following an options appraisal process which, at that point in time, did not identify another feasible option that met secure authentication requirements.

This means users are asked to scan a photo of their passport or driving licence and then to take a live photo of themselves. The software then uses their live photo to compare likeness with the photo in their ID and confirm their identity. There is manual verification for the small number of cases which fail the automatic process. For the limited number of cases where a person's identity cannot be verified in the App, individuals can call the Covid-19 Status Helpline, or use NHS Inform to request a paper Certificate, which will be posted to them.

Additional forms of ID are being added to those that can be used already with biometric processing to ensure that inequalities in access are reduced. Further exploratory work on alternative (non-biometric) identity verification routes is underway.

Alternative routes to prove vaccination status, that did not require using the NHS Scotland COVID Status App, were already established (people can download a PDF or request a paper Certificate).

Many countries accept negative PCR tests or recovery status as an alternative to vaccination. These functions were made available in the Covid Statues app in mid-December. Further development work is being undertaken to extend the inclusion of PCR and LFDs for domestic use. Further information, such as LFD negative test status, will be added in a future release of the App. In the meantime, customers can display an SMS (text) or email which records they have received a negative test. There is no QR code within SMS or emails and so they do not need to be scanned by the NHS Scotland Covid Check App. Venues will instead perform a visual check and no data will be retained. Individuals can get an SMS or email by registering the result of their LFD test on the GOV.UK website.

The testing option requires people to have access to a standard mobile phone, mobile device or computer with an email address and access to a printer. This does not need to be a 'smart phone' and any mobile phone that can receive text messages or has access to email is sufficient. Test results can be displayed on a mobile phone, tablet or other device, or a paper copy can be printed. In Scotland, it is estimated that 88% of households had internet access in 2019, however this varied by household net income and deprivation. The proportion of internet users reporting that they access the internet using a smartphone increased from 81 per cent in 2018 to 86 per cent in 2019^[65].

Exemptions

There are medical exemptions for domestic Covid StatusCertification for the very limited number of people who can neither be safely vaccinated or tested. In the vast majority of cases, a successful route to safe vaccination or testing can be found. Local vaccination centres can help to answer questions about the vaccine and can advise what arrangements may be put in place to enable safe vaccination. In the rare cases where that support does not lead to vaccination, an exemption is offered to the individual which can be used for international use only. If the individual cannot be tested either, they will be advised to obtain proof of evidence from their primary or secondary care clinician in the form of a letter. This evidence will then be assessed by a Scottish Government clinician who will work with the Resolver Group to provide the necessary support on a case-by-case basis to determine whether the individual is also exempt from testing.

For more information on exemptions see the NHS Inform website, call the Covid-19 Status Helpline or visit your local vaccination centre. Medically exempt individuals are provided with paper Certificates which have enhanced security features. Medical exemptions cannot be displayed on the international section of the App due to EU specifications. They are under consideration for a future release of the domestic section of the App. We continue to engage across the four nations to ensure that work around exemptions is taken forward collectively.

All clinical trial participants have received a letter from their Principal Investigator which can be used for proof of their trial status. Clinical trials participants are encouraged to undertake testing and provide a record of a negative test, as they may have received a placebo dose.

While children are exempt from the requirement to prove vaccine status for domestic purposes, 12- 17 year olds who have been vaccinated may choose to download a PDF via NHS Inform, or they may choose to request a paper Certificate by calling the Covid-19 Status Helpline for paper copies.

The paper Certificates are in English. Information about what information the Certificates contain can be requested in other languages and alternative formats including Easy Read, audio and Braille. Information can be found on NHS Inform, or when people request their Certificate.

For more information on the Covid Status Certificate see the Scottish Government website.