RSS del Observatori de Bioètica i Dret UB

During 2020 the Office of the Data Protection Officer (DPO) of the Fundació TICSALUT in collaboration with a multidisciplinary team coordinated by Dr. Itziar de Lecuona, deputy director of the Observatory of Bioethics and Law - UNESCO Chair of Bioethics at the University of Barcelona, have developed a methodology and an agile tool to carry out a DPIA in health based on the model of the Catalan Authority for Data Protection.

This proposal has been adapted to the specific needs of the health care system to evaluate personal data treatments in research and innovation processes. The results are a methodology and a tool that allows a self-assessment to detect risks in the processing of personal data and their mitigation using simple/plain language; with definitions and examples to identify the actors involved and to describe the data processing in order to measure the risks and to establish an action plan.

In short, the proposal helps the data controller and the agents involved in the decision-making process with automated suggestions and allows a detailed analysis of the life cycle of the personal data involved. The DPIA in health care includes specific sections to evaluate the use of emerging technologies such as artificial intelligence. Likewise, the tool enables to show the assessment of the entitled Data Protection Officer. 

The proposal is based in the proactive responsibility and risk assessment in the processing of personal data established by the data protection regulations since 2018 (General Data Protection Regulation). With this tool, the DPO Office contributes to the homogenization and standardization of the methodology and criteria to help the health care entities to carry out their tasks. It deepens in those aspects and particularities of the sector in a coordinated and systematized way.

Today, December 17, 2020, the DPO Office and the team coordinated by Dr. Itziar Lecuona including Ricard Mas -industrial engineer and expert consultant in operations and digital transformation- and Paula Subías -mathematician and specialist in data science applied to health- have presented the methodology and the tool through a case study to the data protection coordinators of the entities adhered to the DPO of Salut (TICSALUT). 

• Methodology and tool to carry out DPIA in healthcare
• Video of the presentation

• Eina de l'AIPD (català)
• Herramienta de EIPD (castellano)
• DPIA tool (English)

This year, 2020, marks the 25th anniversary of the founding of the University of Barcelona’s Bioethics and Law Observatory (OBD), and although in the difficult situation of pandemic and crisis that we are currently suffering it is not the right moment to celebrate, we do not want to let such an important landmark pass without mentioning it and thanking everyone who has made these 25 years of work well done possible. 

You can find a brief summary of what we have done and a selection of photos from these years in which we have been able to celebrate so many things. 

Thank you once again and congratulations to everybody!

This year, 2020, marks the 25th anniversary of the founding of the University of Barcelona’s Bioethics and Law Observatory (OBD), and although in the difficult situation of pandemic and crisis that we are currently suffering it is not the right moment to celebrate, we do not want to let such an important landmark pass without mentioning it and thanking everyone who has made these 25 years of work well done possible. 

You can find a brief summary of what we have done and a selection of photos from these years in which we have been able to celebrate so many things. 

Thank you once again and congratulations to everybody!

The interests of science, technology and society should not prevail over those of the individual. Guaranteeing this principle is one of the main tasks in the research ethics committees (CER), interdisciplinary collegiate bodies set by the law which analyse the scientific validity of research studies and its social value, and which study the rights and interests at stake. Over the last years, the task of the CERs has broadened: not only they assess clinical trials with drugs and medical products but they also analyse projects that use emerging technologies such as artificial intelligence, big data, biometrics and virtual reality, among others.

In this context, the Opinion Group of the Bioethics and Law Observatory – UNESCO Chair in Bioethics at the University of Barcelona (OBD) has published the report Guidelines for reviewing health research and innovation projects that use emergent technologies and personal data, in which they treat challenges, unsolved questions and problems that arise in the research and health innovation projects.

In its first part, the report analyses the current situation and focuses on the use of personal data. The situation of the pandemic has presented several ethical challenges, for instance those related to the development of applications that request personal data and add geolocation. This kind of challenges are also presented in those projects that develop COVID-19 prediction systems based on the programming of algorithms that feed from different sets of personal data, stored in clinical records and other data bases.

The report reminds the reader that this altruistic and solidary model, which involves a transfer of personal data, “should revert to treatments and interventions for the owner of the data or the patients and future generations”. It can also involve knowledge gaining without direct benefit, according to the researchers. However, this transfer “cannot mean that certain sets of personal data should be at everyone’s reach, specially those regarding health”, they note. Access to personal data with healthcare and research purposes includes the professional’s right to keep data secret in order to maintain the confidentiality of the data.

“We cannot guarantee anonymity anymore”
“We went from being anonymous to being re-identifiable”: this is one of the main statements in the third part of the report, which analyses the aspects to take into account for an appropriate protection. Among other, it notes that the current CERs “do not have the appropriate composition nor the necessary skills to assess research and innovation projects” that are presented in the document.

In the final part, the OBD researchers provide recommendations aimed at CERs about the research and health innovation projects that use personal data, as well as the need to introduce profiles of experts on emerging technologies. It also includes recommendations aimed at research and innovation centers to build these committees properly and ensure its independence, and to include the figure of a delegate for data protection.

This publication warns the legislators about the need to develop a regulation for CERs, and to introduce responsible research and innovation (RRI) in a “real and quantifiable” manner, promoted by Europe.

The report Guidelines for reviewing health research and innovation projects that use emergent technologies and personal data has been coordinated by the assistant manager of OBD and lecturer at the Department of Medicine, Itziar de Lecuona. It is published in Catalan, Spanish and English.

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• Document [PDF]

• Press release - 03/11/2020

• Infographic based on the document (also available in Spanish and Catalan)

The publication of this document has received the support of two projects of the European Union's research program Horizon 2020: “MICROB PREDICT: MicroBiome-based biomarkers to Predict decompensation of liver cirrhosis and treatment response” (ref. 825694) and “DECISION: Decompensated Cirrhosis: Identification of New Combinatorial Therapies Based on Systems Approaches” (ref. 847949). This document only reflects the authors' opinion. The European Union's program Horizon 2020 is not responsible for its use.

The institutionalization of surveillance practices to trace contacts and positives raises technical, ethical and legal issues that urgently need to be discussed

The digital measures proposed for exiting confinement have intensified the debate about the protection of privacy during the pandemic, a situation that entails certain restrictions of rights, but which under no circumstances can revoke them. Digital technology, as the medium for moving towards a “new normality”, until the vaccine arrives, could lead us to a covert digital confinement with no expiry date. This would be achieved through the institutionalization of techniques for the digital surveillance of people, raising technical, ethical and legal issues having enormous social impact, which urgently need to be discussed. The decisions that are taken in the context of public health must be proportional to the ends pursued, respectful of people’s rights, temporary and reversible.

The immunity passport, proposed as the measure that would enable us to recover our social life, was ruled out, due to the lack of scientific evidence and because it is incompatible with the protection of fundamental rights and freedoms in our context. It is disproportionate and stigmatizing, and, for practical purposes, it would encourage people to become infected in order to obtain the green light. Our social life does not depend on COVID-19 labels.

The use of apps tracing positives and contacts in order to control a possible new outbreak of COVID-19 obliges us to reflect on Europe’s dependence on American technologies, and our enthusiasm for falsely liberating digital solutions. We should not agree to the default inclusion of this kind of tracing service in smartphones’ operating systems, which imply a digital Big Brother on our doorstep, empowered by coronavirus. The Bluetooth technology chosen for tracing was not designed to manage a pandemic or to guarantee privacy – it could give rise to false positives and poses security problems.

It is necessary to have access to reliable data, which should be accessible, reusable and above all interoperable, and in conditions of security. Moreover, it is necessary to correlate personal health datasets stored in highly protected databases, due to the type of data processed, in order to draw valid conclusions. The installation of an app is no substitute for the traditional mechanisms for identifying positives and contacts, the strengthening of primary healthcare, or scientific evidence on which to base decisions. On no account, however, can it be conceived as a business model unconnected with public health and it is not a measure that will guarantee tourism this summer.

Impossible to guarantee immunity
Fernando Simón, in one of his regular appearances, was astonished, and rightly so, by a journalist’s question about the possibility of including information about people’s immunity in their curriculum vitae, immunity that at this moment cannot be guaranteed. News items in the business sections of some media outlets propose a kind of healthcare identity card with blockchain technology to be able to go back to work, taking it for granted that COVID-19 gives is a reason for any digital measures to be introduced, even if they are contrary to the most fundamental rights and freedoms, in the world of work too. Major consultancies and start-ups seem to be opting for this kind of certificate for workers, to which business managers, health centres and hospitals could gain access via an application, which the authorities would still be validating. It is a business model that might even be of interest to investment funds – now that they are ceasing to invest in old people’s homes – and which would revoke any and all freedom, bringing with it intensive surveillance with measures as immediate as they are profitable, even framed as part of occupational health and safety. 

Various tests used by businesses are not reliable, and personal data management is not something to be taken lightly, because it may give rise to unwanted uses of personal data, and to covert discrimination which may be based on untruthful information. PCR tests and temperature taking require clear criteria by the competent authorities, because situations that were exceptional to begin with have become the norm and they would not always be justified. In short, we must not make the mistake of understanding exiting confinement as a dichotomy between freedom and privacy.

Itziar de Lecuona, Deputy director of the Bioethics and Law Observatory and Lecturer in Bioethics at the School of Medicine, University of Barcelona.

• Published in El Periódico

The measures for leaving lockdown, consisting of identifying possibly infected people and investigating their contacts using digital devices, must be proportional to the ends pursued; they should be temporary and respect people’s rights. Any measures must be based on scientific evidence and not on technological ideas susceptible to personal data markets, under the pretext of Covid-19. We need to have an urgent discussion about the function of the state, tech companies, and how to protect our privacy due to the spread of digital systems based on the correlation of personal data in order to make predictions and improve decision-making.

Health, genetic, biometric and socio-demographic data are personal and specially protected because they could be used for unwanted ends and give rise to covert discrimination. Depending on the uses made of them, the possession of personal datasets by third-party public and/or private companies affects our rights, and gives them extraordinary power over us. It is not a good idea to copy systems established in contexts that are nothing like ours, culturally, socially or politically speaking. 

These “digital” measures must be framed in the context of public health. They are not a digital option for liberating us from the virus, capable of giving us back the freedom we once knew. Attention should be focused on the human factor, because relationships between doctors and patients and between citizens and social and healthcare systems are crucial. Strengthening primary healthcare and doing tests is far better and less invasive than activating the GPS or Bluetooth in our digital devices whether we want to or not.

Acting for the good of the community and for reasons of public health must not deprive us of our rights or condition our freedom. The “immunity passport” – with no scientific evidence to back it up and rejected by the WHO – is the most invasive option and the first one to rule out. Our life in society must not depend on Covid-19 labels.

Due to the development of technology and the enormous amount of information stored in databases, it is virtually impossible to remain anonymous. Initiatives that make it impossible to identify people must be given priority. Exiting lockdown must not mean the institutionalization of the power of big tech. Nor should it imply the state’s absolute control over our behaviour. We have to accept that zero risk does not exist and that local proposals will be useless.

The decisions that are made now will mark the lives and futures of individuals and groups and will determine what kind of society we build due to the SARS-CoV-2 virus. It is imperative, therefore, to think about the part played by technology in our relationship with Covid-19, and whether or not our personal freedom will remain intact and we will be able to tell the future generations about it without feeling ashamed.

Itziar de Lecuona, Deputy director of the Bioethics and Law Observatory and Lecturer in Bioethics at the School of Medicine, University of Barcelona.

• Published in El País

The Revista de Bioética y Derecho of the University of Barcelona announces this call for papers for a monographic issue on “Bioethical issues of the COVID19 pandemic”, coordinated by Dra. María Casado, director of the Observatorio de Bioética y Derecho and holder of the UNESCO Chair on Bioethics, University of Barcelona.

The aim of this initiative is to analyse the lessons learned and the outstanding issues of the COVID19 pandemic, as well as proposing structural measures to avoid a similar scenario in the future. To this, we open our call for collaborations related to the critical analysis of the following topics:

• Bioethics in times of global emergency: justice, solidarity and autonomy.
• Public health ethics (common good, solidarity, responsibility). Tensions between values.
• Restriction of fundamental rights due to the pandemic.
• Big Data, Artificial Intelligence and pandemics.
• Control of health and privacy violation; feasibility of commercialization of health data and reinforcement of state power.
• Infringements of social rights. Allocation and prioritization of resources.
• Clinical decision-making in an emergency context and lack of material resources.
• Population’s or groups’ participation in public health decisions that affect them.
• Psychological, educational and housing implications, among others, resulting from the social isolation measures against COVID-19, especially those affecting groups such as women, children, undocumented migrants, LGTBIQ+, homeless people, etc.
• Consequences of the pandemic and impact of the measures taken among different countries (priorities, effects, public policies) according to their level of industrialization, economic development or geopolitical context.
• Media coverage of the COVID-19 pandemic in printed press, radio and TV, and by web-based news providers.

The journal will accept only original papers written in Spanish, Catalan, French, English, Portuguese or Italian, with a maximum length of 6,000 words, including references, bibliography, tables and graphics. The file must be sent in MS Word format, letter Cambria or Arial 12, double-spaced. Originals must be sent through this link. Original articles will be peer-reviewed and those that pass the selection process will be accepted for publication on the November 2020 issue.

• Deadline for submissions: July 1st, 2020.

The Revista de Bioética y Derecho is a quarterly publication of the Bioethics and Law Observatory - UNESCO Chair in Bioethics of the University of Barcelona. The Journal is for people interested in bioethics applied to health, food and new technologies, within the framework of respect for Human Rights, and with a plural, secular, and interdisciplinary approach. Our Journal is indexed in SciELO, SCOPUS, Erih Plus, IBECS, Carhus +, Redalyc, Latindex Catalogue, DOAJ, among other indexes and repositories whose quality is aknowledged.

• Download the call for papers [PDF]

The proposal contains 31 recommendations to support ethical decision-making and adjust the care intensity in light of a possible overcrowding in Intensive Care Units and Emergency services.

The novel coronavirus infection which is already affecting more than 17,000 people throughout Spain threatens to imminently over-burden the medical care system and exhaust the health resources. Following the proposal of the deontology commission of the Official College of Physicians of Barcelona de Barcelona and based on the Ethical recommendations for ethical decision making in exceptional situations of crisis due to COVID-19 pandemic of the the Spanish Society of Intensive, Critical Medicine and Coronary Units (SEMICYUC), several scientific societies and research institutes have upheld the proposal that aims to guide ethical decision-making in patient admission and management, resource optimization, logistic arrangement or therapeutic intensity adjustment.

Among the recommendations, there is an emergency plan that includes patient relocation throughout different geographical areas, global patient assessment, the prioritization of medical care according to a classification model that takes into consideration factors like the chances of recovery and the medical history, as well as the possibility of no hospitalization for those patients that are least likely to benefit from it. In addition, the guide recommends providing emotional support to family members and professionals given the psychological impact of medical decisions. 

Age should not be the only criterion for prioritizing the care of patients with COVID-19.

It is strongly recommended not to consider the age as the only factor to take in consideration when it comes to assigning resources in response to the issue of the elderly part of the community being the most vulnerable group. The guide advocates for the maximization of the hospital discharge survival and the amount of living years saved just as much as the chances of living throughout each life stage. 

Finally, the recommendations include that it is advisable to share the decision-making between health professionals, patients and family members. Effective communication is a matter of stressing importance in order to improve the understanding of the measures taken. Ultimately, these recommendations aim to provide a guide for ethical decision-making in light of a healthcare emergency within a context of scarce resources.

• General recommendations related to difficult ethical decisions and the adjust of care intensity. Admission to Intensive Care Units in exceptional crisis situations [PDF]

To all members of the UB community,

Regarding the state of alarm pronounced by the Spanish Government, and according to the exceptional measures taken by the Government of Catalonia, the University of Barcelona is minimizing its face-to-face activity.

For this reason, and according to what the Action protocol of the University of Barcelona on the COVID-19 (SARS-CoV-2) health alert, I made the firm decision to close the buildings of the University of Barcelona, except for essential services. As a result of this situation:

• Starting tomorrow, March 15, all buildings and facilities of the University of Barcelona will be closed and access is forbidden except for authorized people. All scheduled activities, including exams and competitive examinations, are called off.
• Should any urgent situation requiring access to the building occur, the General Manager’s Office -for AdSS- or the corresponding Dean’s Office -for TRS- would release an authorisation, which has to be applied to via email address (info-coronavirus@ub.edu).
• All face-to-face academic activities stated in the statement from March 12, 2020, continue to be suspended. The mentioned statement remains valid in everything this new statement does not contradict.
• The University established essential services that will provide assistance in order to guarantee the functioning, maintenance and safety of equipment, animals and facilities, as well as assistance for emergencies.
• The UB has reinforced and provided with digital tools and means to work from home. The staff will keep the necessary contact to receive, in any moment during this emergency, service orders with the aim to preserve the continuity of the essential and main services, which will be offered, as long as it is possible, by working from home.
• The Oficina d’Assistència en Matèria de Registre (Assistance Office concerning records) will offer its services on its website.
• The count of deadlines for the procedures of the University will be suspended as of tomorrow, March 15, 2020, until further notice.

Regarding this exceptional, critical and complex situation, I trust the staff of our University to face it with commitment, support and responsibility. Now more than ever, we have to be united, take care of yourselves, together we will manage to succeed.

We will keep you constantly updated about any news on the website www.ub.edu/coronavirus and via the email address info-coronavirus@ub.edu.

Sincerely,

Joan Elias
Rector

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