FAQs to report on EFR Pilot Being diabetic in Identifying Emerging and Future Risks in remote health monitoring and treatment

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1 FAQs to report on EFR Pilot Being diabetic in Identifying Emerging FAQs to report on EFR Pilot Being diabetic in Identifying Emerging What is this report about? The report presents the results of a pilot that was undertaken in order to test and provide a proof-of-concept of the recently developed ENISA Framework on Emerging and Future Risks (EFR Framework). It is based on a scenario in the area of remote health monitoring and treatment, an area, which was selected after discussions with the EFR Stakeholder Forum. This report presents the results of the pilot exercise, such as major potential emerging and future risks in a possible remote health monitoring and treatment scenario. How is the report structured? The report begins with a cautionary tale, which is based on the application scenario prepared by ENISA and its Stakeholder Forum. This provides a brief overview of the major risks and challenges entailed. The next two sections present the major risks identified in the course of the pilot and the assets, i.e., what we are trying to protect, and finally, the report concludes with a very brief overview of the methodology used, namely the ENISA EFR Framework, in order to identify and analyse the risks. The scenario template and the risk assessment report, on which this report is based, are annexed. What is the EFR Framework and the EFR Stakeholder Forum? Since 2007, ENISA has been conducting a series of activities towards developing a comprehensive framework for identifying and assessing emerging and future risks (EFR). As a result of these activities, ENISA has constructed an EFR Framework. The EFR Framework is scenario-based and consists of certain phases for the formulation and analysis of scenarios, mobilisation of the necessary expertise (human resources) to assess and analyse the scenarios and leveraging of the management capabilities to collect and disseminate assessed information (e.g., scenario descriptions, threats, vulnerabilities, assets, impacts, risks, etc.).

2 The Agency also sought to validate a European capacity for the evaluation of those risks to network and information security that may emerge in the near term, i.e. over the next three years. The work in this area is relatively new and, as such, calls for the interaction and co-operation of many leading experts from different disciplines, which is why ENISA established an EFR Stakeholder Forum and consulted with other subject matter experts. What are the main objectives of this report? The two main objectives of this report are firstly to identify major emerging and future risks of the particular area chosen, which in this case is remote health monitoring and treatment, and secondly to obtain feedback on the EFR Framework, so that it could be updated and improved. Why an e-health scenario? Firstly, the European Commission and some Member States have been actively promoting the merits of e-health in recent years. Health care expenditure represents an increasingly large percentage of national budgets. Officials are interested in e-health in part because it can help to: - Limit costs and improve productivity in areas such as billing and recordkeeping - Reduce medical error - Alleviate unnecessary care and - Achieve savings in business-to-business e-commerce relevant to the health care sector. Nevertheless, e-health remains controversial and, some would say, risky. One of the biggest challenges in implementing e-health concepts is convincing the public that their electronic health records will be safe and secure. In this context a scenario on the issue of e-health and on remote health monitoring and treatment in particular, would be an excellent subject of analysis, the results of which could also contribute to discussions at EU level and have direct policy relevance.

3 FAQs to report on EFR Pilot Being diabetic in Identifying Emerging What is meant by e-health? The Commission has described e-health as the application of information and communications technologies across the whole range of functions that affect the health sector. E-health tools or solutions include products, systems and services that go beyond plain Internet-based applications. They include tools for health authorities and professionals, as well as the delivery of personalised health systems for patients and citizens. What was the reason for the scenario being diabetic in 2011 Based on the considerations, Philips Research (Netherlands) produced an interesting scenario on remote health monitoring and treatment, which formed the basis for the scenario of the EFR pilot (for the complete text of the scenario, please refer to Annex I to the main report). A series of assumptions were made in the development and analysis of the scenario. They are explicitly detailed in the scenario template in Annex I. The assumptions were necessary in order to develop and analyse the scenario and then to identify the risks. The risks are factored into these assumptions, which means if the assumptions are changed, an identified risk may not be valid or an additional risk may emerge. Does this scenario cover all applications in e-health and are there other risks to be identified? The scenario does not and cannot cover all possible aspects of this very wide area of applications and therefore the results produced and the risks identified are by no means exhaustive and the analysis leaves room for other risks to be identified. It does, however, present some of the potential risks and challenges posed by emerging e-health applications. It is expected to contribute to the dialogue on ehealth implementations and main risks that they entail and to fuel further study of these issues.

4 How were the risks identified? The risks were identified in a collaborative effort by ENISA, representatives from the EFR Stakeholder Forum and external subject matter experts. The report, which is the result of a risk assessment exercise based on the scenario of the EFR pilot, identifies 14 risks in total. What are the identified risks in terms of remote health monitoring and treatment? Some of the risks, identified in the report, affect only the individual, while others could affect all users. The risks, listed according to their risk level, impacts and probability, are: 1. Failure to comply with informed consent legislation 2. Failure to comply with data protection legislation 3. Data breaches 4. Repurposing or secondary use of data (mission creep) 5. The user could be compromised 6. Equipment is damaged 7. The system could malfunction and/or break down 8. Theft 9. Inadequate provision or availability of medical services 10. Human error in emergencies 11. The patient might misinterpret the data 12. Medical staff might misinterpret, modify or delete patient data 13. Users may not follow instructions 14. Data surveillance and profiling How were these risks identified? The principal steps taken by the EBIOS 1 experts from Logica, France to identify and assess the risks were the following (For the full risk assessment report produced by the EBIOS experts of Logica (please refer to Annex II): - Formulating the risks - Valuating assets and setting of tolerance levels - Calculating the probability, the attack potential, the opportunity and the probability - Identifying and valuating the impacts - Determining the risk level 1 EBIOS is the acronym for Expression des Besoins et Identification des Objectifs de Sécurité (Expression of Needs and Identification of Security Objectives).

5 There is a section of the report called What are we trying to protect : what does this include? This section identifies the assets, i.e. what are we trying to protect against the risks mentioned above. Assets include any devices, technologies, applications, processes, data or anything of value to the individual, organisation or, indeed, society. Some assets are more valuable than others, of course, and those values may vary over time and/or according to the context. So, what are the assets we are trying to protect? After discussions within our working group, we agreed that in the context of our scenario, we are aiming at protecting the following (please see main report for more detailed information on each of these categories): - Health and life - Human rights and social values - Autonomy - National healthcare system - Mobility - Personal data - Health cards - Health monitoring devices - Personal information technology equipment - Data centres and call centres - Electronic health records (EHR) - Health journal - Electronic prescriptions - Public health research data - Hospital information technology systems - Networks

6 What is the methodology used? During 2008, ENISA worked on developing the EFR Framework. The framework follows a scenario-based approach, where scenarios are used to present a particular case of the chosen technology and/or application and/or topic in order to identify the emerging and future risks. Once identified, the scenario data are subsequently analysed by using existing risk assessment methods. The following diagram presents a high level overview of this approach: The full report is available at: The press release is available at: ml For further details contact: Ulf Bergstrom, Press & Communications Officer ENISA, press@enisa.europa.eu Mobile: or Barbara Daskala, Risk Management Expert at: RiskManagement@enisa.europa.eu