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input/pagecontent/ethical_principles.md

@@ -14,11 +14,13 @@ A good starting point is to identify how the use of a digital solution can contr
 <li>to create and maintain trust in public health activities as part of the health-care system.</li>
 </ol>
 
-The creation and use of a digital solution can contribute to each of these objectives. For example, in relation to objective 1, a digital solution can promote welfare through  the provision of digital health records enabling continuity of care by ensuring that individuals have access to their health data across facilities. Promotion of this objective also contributes to confidence in the health infrastructure of the government, benefitting the whole population. Such an outcome is an important common good – that is, a good for all that cannot be created by each individual alone. Such goods require the coordinated actions of, and support from, governments. In addition, other benefits will follow from the use of a digital solution, because of improved health and subsequent increased opportunities for individuals and communities to make their own choices and pursue their own economic and social goals. 
-
-In relation to objective 2, equal treatment requires respecting and protecting all persons equally and acting to ensure, as far as possible, that there is no discrimination against anyone. An example of how to work towards this objective is to ensure that appropriate personal data protection safeguards are implemented. Individual health data is private information, and protections need to be in place to ensure that no individual is forced to disclose or publicly display their personal health record (PHR) to access any public area or activity <a href=#ref_1>(1)</a>. Such a practice and/or the lack of a PHR itself may result in the stigmatization of individuals without a PHR and may exacerbate the risk of harms. 
-
-Another example of working towards objective 2 is to think about ways to try and achieve equity through the distribution of health resources. While a digital solution may offer a more reliable, accurate and trusted mechanism to record an personal health history, they risk exacerbating health inequities, for the following reasons. 
+<p>
+    The creation and use of a digital solution can contribute to each of these objectives. For example, in relation to objective 1, a digital solution can promote welfare through  the provision of digital health records enabling continuity of care by ensuring that individuals have access to their health data across facilities. Promotion of this objective also contributes to confidence in the health infrastructure of the government, benefitting the whole population. Such an outcome is an important common good – that is, a good for all that cannot be created by each individual alone. Such goods require the coordinated actions of, and support from, governments. In addition, other benefits will follow from the use of a digital solution, because of improved health and subsequent increased opportunities for individuals and communities to make their own choices and pursue their own economic and social goals. 
+
+    In relation to objective 2, equal treatment requires respecting and protecting all persons equally and acting to ensure, as far as possible, that there is no discrimination against anyone. An example of how to work towards this objective is to ensure that appropriate personal data protection safeguards are implemented. Individual health data is private information, and protections need to be in place to ensure that no individual is forced to disclose or publicly display their personal health record (PHR) to access any public area or activity [(1)](#ref_1). Such a practice and/or the lack of a PHR itself may result in the stigmatization of individuals without a PHR and may exacerbate the risk of harms. 
+
+    Another example of working towards objective 2 is to think about ways to try and achieve equity through the distribution of health resources. While a digital solution may offer a more reliable, accurate and trusted mechanism to record an personal health history, they risk exacerbating health inequities, for the following reasons. 
+</p>
 
 → A PHR may increase digital exclusion if its application and use and requires that individuals have access to a digital infrastructure or if that digital infrastructure is too burdensome for all Member States to deploy. 
 
@@ -36,11 +38,11 @@ The pursuit of the objectives above can create ethical problems. One way to miti
 
 **→ ACCOUNTABILITY:** providing a clear framework for who is responsible for what, and how responsibilities will be regulated and enforced. 
 
-**→ RESPONSIVENESS:** providing mechanisms and opportunities to review and revise decisions and policies based on evolving scientific evidence and other relevant data. This may include public consultation or engagement with a wide range of experts, industries and other stakeholders so that the policies are responsive to real and perceived ethical issues and concerns. Particularly important stakeholders are those who are likely to be disadvantaged or face distinct or heightened risks with the creation of a PHR, such as individuals who are unable or unwilling to create a PHR, i.e. individuals with insecure or invalid citizenship or residency status, and individuals who may face other barriers in obtaining or using a PHR (20). 
+**→ RESPONSIVENESS:** providing mechanisms and opportunities to review and revise decisions and policies based on evolving scientific evidence and other relevant data. This may include public consultation or engagement with a wide range of experts, industries and other stakeholders so that the policies are responsive to real and perceived ethical issues and concerns. Particularly important stakeholders are those who are likely to be disadvantaged or face distinct or heightened risks with the creation of a PHR, such as individuals who are unable or unwilling to create a PHR, i.e. individuals with insecure or invalid citizenship or residency status, and individuals who may face other barriers in obtaining or using a PHR <a href=#ref_2>(2)</a>. 
 
 ### Ethical considerations related to further potential uses of digital personal health records for public health security measures 
 
-A number of further possible uses for digital PHRs raise ethical issues. In the context of a public health emergency, a digital PHR might play a role in achieving various public health purposes such as determining vaccination coverage in a given population, which may help to determine when to lift or relax public health and social measures (PHSMs) at a population level. A digital PHR might also be used to facilitate individualized exemption from, or, reduction of PHSMs (e.g. reduced quarantine time post exposure) or individual access to an activity based on proof of vaccination (if such uses are held to be ethical), which we can term a “health pass” function. The potential deployment or utilization of a digital PHR for these purposes, particularly as a health pass, engenders a number of potential ethical problems for individuals and communities, and human rights challenges (21,22). 
+A number of further possible uses for digital PHRs raise ethical issues. In the context of a public health emergency, a digital PHR might play a role in achieving various public health purposes such as determining vaccination coverage in a given population, which may help to determine when to lift or relax public health and social measures (PHSMs) at a population level. A digital PHR might also be used to facilitate individualized exemption from, or, reduction of PHSMs (e.g. reduced quarantine time post exposure) or individual access to an activity based on proof of vaccination (if such uses are held to be ethical), which we can term a “health pass” function. The potential deployment or utilization of a digital PHR for these purposes, particularly as a health pass, engenders a number of potential ethical problems for individuals and communities, and human rights challenges (<a href=#ref_3>3</a>,<a href=#ref_4>4</a>). 
 
 First, use of a digital PHR as a health pass raises a distinct set of risks because of current scientific uncertainties emergent diseases.  For example, during the COVID-19 Public Health Emergency of International Concern (PHEIC), COVID-19 vaccines have demonstrated efficacy and effectiveness in preventing severe disease and death, the extent to which each vaccine prevents transmission of SARS-CoV-2 to susceptible individuals were not fully assessed. How long each vaccine confers protection against severe disease and against infection, and how well each protects against current and future variants of SARS-CoV-2 were not fully known. In this context of scientific uncertainty, use of a digital PHR as a health pass based solely on individual vaccination status may increase the risk of disease spread. This is particularly the case if individuals with a digital PHR are completely exempted from PHSMs or if it is hard to enforce individuals’ compliance with required 
 
@@ -52,9 +54,9 @@ Second, some potential behavioural responses to a digital PHR in its role as a h
 
 → Individuals may be less willing to disclose their medical history and (potential) contraindications to a public health intervention (e.g. vaccine), in order to obtain a corresponding digital PHR, which increases the risk of adverse events. 
 
-→ The creation of a digital PHR following vaccination for each individual may incentivize more people to participate in a public health measure (e.g. receive a vaccine) to access the benefits of a digital PHR. However, it may also increase hesitancy to participate in the public health measure because of privacy and other concerns that the vaccination record could be linked to personal data and be used for functions other than those originally intended (e.g. surveillance of individual health status), or be used by unintended third parties (e.g. immigration, commercial entities, researchers) (23). 
+→ The creation of a digital PHR following vaccination for each individual may incentivize more people to participate in a public health measure (e.g. receive a vaccine) to access the benefits of a digital PHR. However, it may also increase hesitancy to participate in the public health measure because of privacy and other concerns that the vaccination record could be linked to personal data and be used for functions other than those originally intended (e.g. surveillance of individual health status), or be used by unintended third parties (e.g. immigration, commercial entities, researchers) <a href=#ref_5>(5)</a>. 
 
-Third, a digital PHR in its use as a health pass risks introducing unfair disadvantages and injustices. For example, during the COVID-19 PHEIC, the initially limited supply of COVID-19 vaccine within some countries had been distributed to prioritize those at greatest risk of infection (such as health-care workers) or severe outcomes (such as the elderly).  There is a danger that those who are willing to be vaccinated but have not yet been offered a vaccine, or those who are unable to be vaccinated for medical reasons, would be unfairly disadvantaged if a digital PHR incorporated health pass functions. Consideration should be given to whether individuals could use other proofs of health status to allow them similar access to the same services while mitigating the risk of disease spread. For example, during the COVID-19 PHEIC, these other proofs may have included a negative COVID-19 test or proof of post-infection-acquired immunity based on tests that are reliable and accurate (which have been called immunity certificates), although this also raises considerable scientific and ethical concerns (24). 
+Third, a digital PHR in its use as a health pass risks introducing unfair disadvantages and injustices. For example, during the COVID-19 PHEIC, the initially limited supply of COVID-19 vaccine within some countries had been distributed to prioritize those at greatest risk of infection (such as health-care workers) or severe outcomes (such as the elderly).  There is a danger that those who are willing to be vaccinated but have not yet been offered a vaccine, or those who are unable to be vaccinated for medical reasons, would be unfairly disadvantaged if a digital PHR incorporated health pass functions. Consideration should be given to whether individuals could use other proofs of health status to allow them similar access to the same services while mitigating the risk of disease spread. For example, during the COVID-19 PHEIC, these other proofs may have included a negative COVID-19 test or proof of post-infection-acquired immunity based on tests that are reliable and accurate (which have been called immunity certificates), although this also raises considerable scientific and ethical concerns <a href=#ref_6>(6)</a>. 
 
 ### Recommendations 
 
@@ -89,11 +91,7 @@ The design, development and implementation of a digital solution raises many eth
 <p>
     Implementation details of a digital solution relevant to users should be communicated in a transparent manner, which may contribute to the promotion of public trust and acceptance of the solution. This communication includes how the solution would work to benefit individuals and public health, the policies and mechanisms in place to limit access to and use of the solution by third parties, whether personal health data are linked to other types of data and the purposes of any data linkage. 
 
-    If, in the future, the uses of the solution are extended into other scientific or public health purposes (e.g. programme monitoring or research), data subjects and other members of the public should be informed of the nature and occurrences of these activities in advance, the ethics oversight 
-
-    or governance structure in place (including for surveillance activities (25), and options for controlling or limiting personal health data for these uses. personal health data are sensitive and should, in general, be anonymized (or pseudonymized, or de-identified) for scientific or public health 
-
-    purposes, to minimize risks to the data subjects. Where personal health data need to be retained in an identifiable form for these purposes, consideration should be given to whether consent is required or should be waived based on satisfaction of appropriate ethical criteria (e.g. minimal risk, impracticability of obtaining consent, no adverse effects on the rights and welfare of the data subjects, and serving a public health good). 
+    If, in the future, the uses of the solution are extended into other scientific or public health purposes (e.g. programme monitoring or research), data subjects and other members of the public should be informed of the nature and occurrences of these activities in advance, the ethics oversight or governance structure in place (including for surveillance activities <a href=#ref_7>(7)</a>), and options for controlling or limiting personal health data for these uses. personal health data are sensitive and should, in general, be anonymized (or pseudonymized, or de-identified) for scientific or public health purposes, to minimize risks to the data subjects. Where personal health data need to be retained in an identifiable form for these purposes, consideration should be given to whether consent is required or should be waived based on satisfaction of appropriate ethical criteria (e.g. minimal risk, impracticability of obtaining consent, no adverse effects on the rights and welfare of the data subjects, and serving a public health good). 
 </p></li>
 
 <li><b>THE DIGITAL SOLUTION SHOULD BE CONSTANTLY MONITORED FOR IMPACT AND ADJUSTED AS NECESSARY.</b>
@@ -195,6 +193,27 @@ Digital technology should not be the only mechanism available for verification.
     Policy brief. In: Swiss National COVID-19 Science Task Force [website]. Zurich: ETH Board; 19 February 2021 (https://
     sciencetaskforce.ch/en/policy-brief/requiring-proof-of-covid-19-vaccination-vaccine-passports-certificates-key-ethicallegal-
     and-social-issues, accessed 27 June 2021).</li>
-
+    <li href="ref_2">
+        What place should COVID-19 vaccine passports have in society? Ada Lovelace Institute; 17 February 2021 (https://
+    www.adalovelaceinstitute.org/wp-content/uploads/2021/02/COVID-19-vaccine-passports-rapid-expert-deliberation.pdf,
+    accessed 27 June 2021).
+    </li>
+    <li href="ref_3">Committee on Bioethics. Statement on human rights considerations relevant to “vaccine pass” and similar documents.
+        Strasbourg: Council of Europe; 4 May 2021 (https://rm.coe.int/dh-bio-2021-7-final-statement-vaccines-e/1680a259dd,
+        accessed 27 June 2021).
+    </li>
+    <li href="ref_4">COVID-19 Vaccination certificates and lifting public health and social measures: ethical considerations. Geneva: World
+        Health Organization; forthcoming.
+    </li>
+    <li href="ref_5">Twelve criteria for the development and use of COVID-19 vaccine passports. Pre-print paper. London: The Royal Society
+        The Royal Society SET-C (Science in Emergencies Tasking – COVID); 14 February 2021 (https://royalsociety.org/-/media/
+        policy/projects/set-c/set-c-vaccine-passports.pdf, accessed 27 June 2021).
+    </li>
+    <li href="ref_6">Voo TC, Reis AA, Thomé B, Ho CW, Tam CC, Kelly-Cirino C, et al. Immunity certification for COVID-19: ethical
+        considerations. Bulletin of the World Health Organization. 2021;99(2):155–61. doi:10.2471/BLT.20.280701.
+    </li>
+    <li href="ref_7">Guidelines on ethical issues in public health surveillance. Geneva: World Health Organization, 2017 (https://www.who.int/
+        publications/i/item/who-guidelines-on-ethical-issues-in-public-health-surveillance, accessed 27 June 2021).
+    </li>
 </ol>