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February 2020

Avicenna Monthly Newsletter 

Key highlights

  • The Avicenna Alliance co-organises a public workshop on good simulation practices in health technologies at the FDA in April
  • The Avicenna Alliance organises an “Avicenna Day” in Paris in August
  • New European Commission's Data Strategy mentions benefits of CM&S and digital twins
  • The European Commission released the White Paper on Artificial Intelligence
  • The European Commission launched a consultation for Europe's beating cancer plan
Policy Updates

European Commission's Data Strategy mentions benefits of CM&S and digital twins 

On 19 February, the European Commission has released a communication addressing the European strategy for data which is part of a broader policy package aiming at making the EU fit for the digital age. The European strategy for data aims at creating a single market for data that will ensure Europe's global competitiveness and data sovereignty.


The European Commission has put together a four-pillar strategy which entails several actions hat will be taken by the Commission during the next three years:
 

      1.   Pillar A - A cross-sectoral governance framework for data access and use:
  • Propose a legislative framework for the governance of common European data spaces (Q4 - 2020);
  • Adopt and implement act on high-value datasets (Q-2021);
  • Propose a Data Act (2021);
  • Conduct an analysis of the importance of data in the digital economy and review of the existing policy framework in the context of the Digital Services Act package (Q4 – 2020)
      2. Pillar B - Enablers: Investments in data and strengthening Europe's capabilities                 and  infrastructures for hosting, processing and using data, interoperability:
  • Invest in a high Impact project on European data space. The Commission aims at investing 2 billion euro (2022);
  • Sign Memoranda of Understanding with Member States on cloud federation (Q3 - 2023);
  • Launch a European cloud services marketplace and integrating the full stack of cloud services offering (Q4 - 2022);
  •  Create an EU self-regulatory cloud rulebook (Q2 - 2022).

     3. Pillar C - Competences: Empowering individuals, investing in skills in SMEs:

  • Enhance the portability right for individuals (Article 20 GDPR) to give Eu citizens more control over who can access and use machine-generated data.
     4. Pillar D - Common European data spaces in strategic sectors and domains of public         interest:
  • The Commission will support the establishment of nine common European data space related to industry, Green Deal, mobility, health, finance, energy, agriculture public administration and European skills.
We are very pleased to note that the European Commission refers several times to computer modelling and simulation (CM&S) and digital twins. The Commission recognises the opportunity that digital twins can bring for healthcare and how data could improve personalised medicine.

The Commission Data Strategy seems to be very ambitious and foresees the creation of European Data Spaces and federated cloud infrastructures with a total funding of 4-6 billion euros. The Data platforms will aim to offer access to a large diversity of cloud services for data storage but also applications ranging from artificial intelligence to simulation, modelling, digital twins and high performances computing (HPC) resources.

Following the publication of the European Data Strategy, the Commission launched a public online consultation on the European strategy for data. This is an opportunity to express your concerns and doubts and give guidance to the Commission.

       The European Commission released the White Paper on artificial intelligence 


On 19 February 2020, the European Commission released its package on artificial intelligence and data which includes a white paper on artificial intelligence.  The purpose of this White Paper is to set out policy and legal options on how to promote the uptake of AI and to address the risks associated with certain uses of this new technology. 


The European Commission envisages a framework for trustworthy Artificial Intelligence under two different mechanisms:

1. Policy actions

The European Commission identifies serious policy actions to support the development and uptake of AI across the EU economy:
  • Working with Member States in order to review the Coordinated Plan  by end 2020;
  • Set up a new public private partnership in A;
  • Initiate open and transparent sector dialogues giving priority to healthcare, rural administrations and public service operators;
  • Securing access to data and computing infrastructures through the European data strategy;
  • Cooperation with other international organisations.
 2. Legal actions

The European Commission suggests a number of risk-based Regulatory measures with healthcare being identified as a high risk application and subject to the highest standards. These standards would apply to all economic actors operating in the EU and could include:
  • Ensuring the protection and respect of EU’s values and rules when it comes to data used to train AI systems;
  • Keeping of records and data;
  • Information provision (transparency);
  • Robustness and accuracy of high-risk AI applications;
  • Human oversight;
  • Specific requirements for remote biometric identification.
Changes to broader legislation such as the Products Liability Directive as well as Adjustments concerning the safety and liability implications of Artificial intelligence, the internet of Things and robotics are also considered. 

The Commission is tackling such a major issue such as liability for AI head-on shows how seriously the Commission is about regulating this sector. That liability has such a heavy focus of this paper as does the emphasis on healthcare as “high risk” shows a very cautious approach.

The Commission aims to follow-up on this White Paper by Q4 2020 with both legislative and non-legislative initiatives foreseen by the Commission and the European Parliament.

The White Paper is open for public consultation until 31 May 2020. This is an opportunity to provide feedback on the policy and legal actions the Commission has identified. 

                    The Europan Commission released its communication  entitled                                                               "shaping Europe's Digital future"

          

On 19 February, the European Commission published its communication entitled "Shaping Europe's Digital future". The purpose of this communication addressed to the European Parliament, the European Economic and Social Committee and the Committee of Regions is to inform them about the issue of Digital Europe and shape the goals for 2025. 

The above Communication accompanies the White Paper on Artificial Intelligence (AI) and the Communication on the European Data Strategy. The document presents three main pillars under each of which a number of specific goals were formulated:

  1. Technology that works for people;
  2.  A fair and competitive digital economy;
  3.  A digital and sustainable society.

This communication’s health relevance is relatively low, it rather focuses on the general direction of the Commission’s digitalisation plan for the next five years to come. Nonetheless, this communication does refer to Electronic Health Records (EHRs) and European health data space and recognises their role in better chronic disease management that – according to the Commission – drains over 70% of the EU health system resources. This could indicate that the European Commission is committed to continue in the path of the 2019 Recommendation on harmonising cross-border EHRs with the creation of the EHR exchange format. 

This document also recognises the importance of AI and big data in everyday life. AI is expected to be a major focus of the Commission’s digitalisation agenda as indicated in the white paper on artificial intelligence.

                                            A European Parliament artificial intelligence package


On 11 February, the Members of the European Parliament (MEPs) Axel Voss (EPP, Germany), Ibán García del Blanco (S&D, Spain) and Stéphane Sejourné (RE, France) held a press conference in Strasbourg to mark the beginning of their work as rapporteurs on a European Parliament Artificial Intelligence package in the Parliament’s Legal Affairs Committee (JURI)

The package consists of three reports:

  1. A 'Framework of ethical aspects of artificial intelligence, robotics and related technologies'
  • This report is a response to the EU 2019 guidelines on ethics in AI as well as  Ursula Von der Leyen’s promise, the new President of the European Commission,  to propose legislation to address the human and ethical implications of Artificial Intelligence (AI) during her first 100 days in office;
  • The major goal of this report would be to address a number of ethical concerns, relating primarily to the risks facing human rights and fundamental freedoms. For instance, AI poses risks to the right to personal data protection and privacy, and equally so a risk of discrimination when algorithms are used for purpose such as to profile people.
       2A 'Civil liability regime for artificial intelligence'         3. A 'Intellectual property rights for the development of artificial intelligence technologies' 
  • This will be a non-binding report as it is based on an own-initiative procedure.
  • In the 2018 Communication of the European Commission on artificial intelligence, the European Commission considered that reflection will be needed on interactions between AI and intellectual property rights, from the perspective of both intellectual property offices and users, with a view to fostering innovation and legal certainty in a balanced way. Using AI to create works can have implications on intellectual property, with questions arising for instance on patentability, copyright and right ownership.
The European Commission will follow-up to the White Paper on Artificial Intelligence, including on safety, liability, fundamental rights and data for Q4 2020. Legislative and non-legislative procedures will be initiated both by the European Commission and the European Parliament.

     The European Commisison High-level Expert Group on B2G Data Sharing                                      released a report on data sharing for the public interest


On 19 February 2020 the European Commission High-Level Expert Group on B2G Data Sharing released an advisory report on data sharing for the public interest.  This report provides a detailed overview of the main obstacles to data sharing in the EU and proposes a comprehensive framework of policy, legal and funding recommendations to enable scalable, responsible and sustainable B2G data sharing for the public interest.

The High-Level Expert Group on B2G Data Sharing identifies a set of different barriers and recommendations in relation with data sharing in the EU:

  1. Obstacles related to the lack of governance structures and harmonisation in the EU:
       Key recommendations
  • Member States should put in place national governance structures that support B2G data sharing;
  • The European Commission should encourage the creation of a recognised data steward function in both the public and private sectors;
  • The European Commission should explore the creation of an EU regulatory framework providing a minimum level of harmonisation for B2G data-sharing processes;
  1. Obstacles related to accountability, transparency and compliance with ethical principles as well as to people empowerment:
      Key recommendations
  • User-friendly data-donation mechanisms should be created;
  • The European Commission should explore whether to develop ethical guidelines on data use, including for the public interest, and taking into account the Ethic guidelines for trustworthy AI;
  • Member states should foster a data-literate public sector, by investing in the training and reskilling of policymakers and pubic-sector workers.
  1. Obstacles related to trust between the private and public sectors as well as the general public:
      Key recommendations
  • The European Commission and Member States should explore incentivising mechanisms, such as public recognition programmes, to increase B2G data sharing on a voluntary basis;
  • Reaping the full benefits of the EU’s Horizon Europe and Digital Europe funding programmes in the development of the technologies necessary for B2G data sharing;

The Expert Group also revised the principles on private sector data sharing in B2G contexts and included new principles on accountability and on fair and ethical data use, which should guide B2G data sharing for the public interest.

The report does not bring specific insights in relation to sectors involved in the process of data sharing in the EU. Opportunities and risks related to data sharing in the healthcare sector are not specifically addressed in the report.

The European Commission launched consultation for Europe's beating cancer plan

On 4 February 2020, the European Commission officially opened the consultation period for Europe’s Beating Cancer Plan. The roadmap for the Europe’s Beating Cancer Plan initiative is open for feedback until 3 March.


The roadmap presents the objectives and specific actions that the Commission will undertake in five key focus areas of the Plan. The Roadmap informs about the specific issues within the cancer field that the Beating Cancer Plan will aim to tackle, such as knowledge gaps and implementation of best practices, uneven access to preventive measures, treatment and cancer care, unfit healthcare models and skills. Feedback on the roadmap is, therefore, a chance to provide input into how the Plan will deal with key issues listed above.

Feedback will also be considered in the drafting of the final Plan, which will be of high importance as cancer is a priority in the European agenda and this is likely to continue for the current legislative term.

In addition to the feedback on the roadmap, the following consultations will be carried out by the Commission:  
  1. A public consultation that will take a form of an online questionnaire to gather views of citizens and organisations – the consultation will be open for a period of 12 weeks from the date of its launch; 
  2. Targeted stakeholder consultation that will be carried out through online surveys, focus groups, workshops, potentially interviews through the EU Health Policy Platform; 
  3. Existing cancer expert groups and key international organisations will be consulted on specific issues. Commissioner for Health and Food Safety Stella Kyriakides has already held a number of high level meetings with patient organisations and other healthcare associations. 

              Key conclusions of the workshops on common European data spaces

On 29 January the Commission organised a workshop in Brussels to explore how Member States are implementing the General Data Protection Regulation (GDPR) rules for the protection of personal data in the field of health. The goal of the workshop was to identify possible differences and examine how this may affect the cross-border exchange of health data in the EU. 

This workshop discussed issues related to the implementation of the GDPR in the field of health. Discrepancies between Members States raise concerns in a number of areas:

  • Lack of harmonisation in the Single Market;
  • Difference in standards for the protection of personal data in the field of health;
  • Adverse effects on the exchange and sharing of health data across Europe.
Existing national and EU rules on the processing of health data were discussed in this workshop, including the specificities of these rules for the two main classifications of health data usage – primary use of data (used for healthcare delivery) and secondary use of data (used for research, policymaking and development of private services in the field of health). The discussions addressed the following issues of interest:
  • Citizens’ access to their personal data and the portability of such data to other operators;
  • National governance models, databases and codes of conduct for secondary use of health data;
  • Potential gaps and needs regarding health data usage within the EU.
This workshop is the first of a three-part series of workshops that will take place between January and April 2020. These workshops will contribute to a legal study commissioned by the Commission in view of the future establishment of a European Health Data Space.
Awards & Prices

The European Commission launched the seventh edition of the EU Prize for
                                                       Women Innovators

 On 11 February the European Commission launched the seventh edition of the EU Prize for Women Innovators, including in health care, from across the EU. The contest is funded under Horizon 2020, the current EU research and innovation programme. Three “Women Innovators" will each receive €100,000, and another €50,000 will be awarded to a “Rising Innovator”, an exceptional entrepreneur at the beginning of her career.

The contest is open to women across the EU and countries associated to Horizon 2020 who have founded or co-founded an existing and active company before 1 January 2018. More information on eligibility and award criteria is available online. The prize applications is an opportunity for women among the Avicenna Alliance to apply for an award of €100,000 or €50,000. I

f you think you have what it takes to become the next EU Woman Innovator, don’t miss your chance and apply before Tuesday 21 April at 17:00 CET (Brussels time).
 

Events and webinars

                                                        EuroHPC Summit Week 2020 

The EuroHPC Summit Week (EHPCSW) 2020 will gather the main European stakeholders from the High Performance Computing (HPC) community: from technology suppliers, infrastructures to scientific and industrial users. The event will happen from 23 March to 27 March 2020 in Porto.

The EHPCSW will offer a wide variety of workshops covering a number of application areas where HPC technologies and infrastructures are key. A specific attention will be given to the EuroHPC Joint Undertaking (EuroHPC JU), which will organise a number of open sessions, providing the audience with information about the JUs activities. The conference  will also provide a great opportunity to network with all relevant European HPC stakeholders.

The event is organised by the European Extreme Data & Computing Initiative (EXDCI-2), the Partnership for Advanced Computing in Europe (PRACE), and the European Technology Platform for High-Performance Computing (ETP4HPC) with the support of EuroHPC JU.

The event is subject to registration. Attendance to the EHPCW including PRACEdays20 is free of charge and includes admission to all sessions, workshops and tracks, as well as the full social programme. 

More practical details and information can be found on the PRACE dedicated webpage.

                   The 20th International Conference on Pharmaceutical Medicine

The IFAPP (the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine) and the SIMeF (the Italian Association of Pharmaceutical Medicine) are organizing the forthcoming 20th International Conference on Pharmaceutical Medicine (XX ICPM) and the SIMeF National Conference from March 25 to March 27 2020 in Rome.

The event will address issues related to "Patients Centered Medicines Development".




During the conference, Mediolanum Cardio Research (MCR),  Member of the Avicenna Alliance,  will present a poster entitled "Applying the 3R's principle in clinical development and the future role of in-silico clinical trials: the experience of the InSilc project".

If you are interested in this event, please find more information regarding the programme here and the registration here.

Alliance co-organises a public workshop on good simulation practices
                                                   in health technologies 

The Avicenna Alliance, the Medical Device Innovation Consortium (MDIC) and the Food and Drugs Administration (FDA) co-organise a public workshop on good simulation practices in heath technologies from April 13 to April 15 2020 at the FDA White Oak Campus, 10903 New Hampshire Ave, Building 31, Room 1503 Silver Spring, MD 20993 United States.

This workshop will include multiple panel discussions, presentations, a poster session, and a mock pre-submission meeting.
Discussion topics will include:

  • Successes, opportunities, and challenges for simulation in health technologies;
  • The vast regulatory landscape for simulation in health technologies;
  • The role of standards in scientific and regulatory decision-making with modelling and simulation.

Please find more information regarding the agenda and the registration here.

                            Save the Date for the  “Avicenna Day” in August 2020

On Tuesday 25 August 2020, the Avicenna Alliance will organise an "Avicenna Day" in Paris at the Jussieu Campus of Sorbonne University.

This will take place the day before VPH2020 Conference taking place from 26 to 28 August at the same venue. Further information will be shortly disclosed but in the meantime, we invite all of you to save this importante vent in your calendars as we are looking forward to seeing al of you in Paris!

                   The 20th International Conference on Pharmaceutical Medicine

The International Materials Applications & Technologies Conference and Exhibition (IMAT)  event will be held in Cleveland from September 14 to September 17 2020. The conference will be framed around technical sessions, education courses, high level keynotes, networking events, and an exhibit floor. The conference theme, Solving Global Materials Challenges, will feature programming specifically designed to appeal to materials professionals from industry, academia, and government.

Among the diverse range of topics discussed we can note artificial intelligence and machine learning for materials as well as medical /biomaterials driving for delivered patient value.

This is an opportunity to learn, share, and network!

If you are interested in the event, please find more information regarding the programme here and the registration here.

Must read papers as recommendation
After Brexit, UK scientists face a long road to mend ties with Europe
 

Following the withdrawal of the UK from the EU, the top issue now for researchers is UK participation in Europe’s research program, Horizon Europe, which will run from 2021 to 2027. At about €90 billion, it is likely to be the bloc’s biggest ever. UK researchers now receive about £1.5 billion per year from the current 7-year program, Horizon 2020, and during the transition, they will get the remaining year of grant money owed under the scheme. To join Horizon Europe, however, the United Kingdom will have to pay to access it in the same way as 16 other non-EU countries, including Switzerland, Norway, and Israel.

Although UK and EU scientists both want such a deal, European politicians may use it as a bargaining chip in trickier negotiations, such as over border arrangements, says James Wilsdon, a science policy specialist at the University of Sheffield. “In what possible sense is it in [Europe’s] interest to stitch up a neat package on science and put a bow on it for London?” Indeed, Mariya Gabriel, EU Commissioner for Innovation, Research, Culture, Education and Youth, indicated in an interview this month that the European Union would not offer a separate deal on research.

If you wish to read more about this analysis please have a look here.

                            Regular Acceptance Of Simulation Studies More Likely In 2020s
                 Novadiscovery And Debiopharm Talk In Silico Studies And Virtual Trial Technology

We are pleased to announce that two Avicenna Members, Novadiscovery and Voisin Consulting Life Sciences, co-authored an article which was published by Regulatory Rapporteur.

If you wish to read the article please have look here.

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