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Security and resilience for ehealth Infrastructures and Service Dimitra Liveri Network and Information Security Expert, ENISA European Union Agency For Network And Information Security

Securing Europe s Information society 2

Positioning ENISA activities CAPACITY Hands on activities POLICY Support MS & COM in Policy implementation Harmonisation across EU EXPERTISE Recommendations Independent Advice 3

Predicting the future: Hospitals under attack 4

Indicative list of Incidents - DDoS in central Health Information System in Finland (KELA), causing disruption for two days. - Two hospitals in Germany were victims of ransomware campaigns in February. Neuss-based Lukas Hospital did not have email access and was conducting business using pencils, paper and fax machines. Klinikum Arnsberg hospital was also affected by a ransomware attack. - Hundreds of planned operations, outpatient appointments, and diagnostic procedures have been canceled at multiple hospitals in Lincolnshire, England, after a "major" computer virus compromised the National Health Service (NHS). - Theft of healthcare data in hospital in Greece, causing loss of data of patients. - And many more 5

The Network and Information Security Directive 6

Obligations for MSs on OESs - Identification of operators of essential services - Minimum security measures to ensure a level of security appropriate to the risks - Incident notification to prevent and minimize the impact of incidents on the IT systems that provide services - Make sure authorities have the powers and means to assess security and check evidence of compliance for OES 7

Working groups under the NISD NIS Directive Groups Cooperation Group CSIRT ENISA Identification Criteria Subgroup Security Measures Subgroup Incident Reporting Subgroup ENISA 8

NIS directive - TIMELINE August 2016 - Entry into force February 2017 6 months Cooperation Group starts its tasks August 2017 February 2018 12 months 18 months Adoption of implementing on security and notification requirements for DSPs Cooperation Group establishes work programme 9 May 2018 21 months Transposition into national law November 2018 27 months Member States to identify operators of essential services May 2019 May 2021 33 months (i.e. 1 year after transposition) 57 months (i.e. 3 years after transposition) Commission report - consistency of Member States' identification of OES Commission review 9

And this is not the only legislation targeting healthcare - General Data Protection Regulation - Implementation of security measures - Reporting data breaches to DPA - Perform Privacy impact assessment - Medical Devices Regulation - Compliance to safety and performance requirements for medical devices manufacturers - Notification obligation in the case of an incident in a vigilant system - Use of harmonized standards 10

Cyber Security in the Healthcare Sector situational analysis - Healthcare organisations are considered Operators of Essential Services thus is scope of the NISD - Low maturity on cyber security in the healthcare sector i.e. hospitals don t have a CISO - Hospitals are easy targets for malicious attackers i.e. cases of ransomware attacks in hospitals across the EU, DDoS attack in Finnish ehealth system - Lack of security awareness in the involved stakeholders and use of walk arounds i.e. physicians, administrative parsonel, patients etc - Life span of the medical devices in use i.e. CAT scanners or MRI machines can be outdated and patch management process usually is a third party task to perform

Cyber Security in the Healthcare Sector ENISA activities Security and Resilience for ehealth Infrastructures and Services (2015) Cyber Security for Smart hospitals (IoT in Healthcare) (2016) NISD implementation in Healthcare in the MS (details ) Cloud security in ehealth (on going) [OES-DSP dependency] Security self assessment questionnaire

NISD Implementation in the Healthcare Sector in the MS - 2017 Perform stocktaking of existing guidelines/schemes in the different Member States and international standards on cyber security in healthcare. Identify of baseline security measures for healthcare organisations. Identify incident notification approaches. Map interdependencies to other sectors and Digital Service Providers. Survey on Incident Reporting open for dissemination! https://ec.europa.eu/eusurvey/runner/incidentreporti ng_oes 13

ehealth experts group ENISA collaborates with HCO to setup pilots across the EU 14

Dissemination Activities - 1 st ehealth Security workshop 2015 Brussels, together with DG CNCT H3-2 nd ehealth Security workshop 2016 Vienna, together with the Hospitals Association of Vienna - Session moderation during ehealth Week 2017, speaking slot at ehealth Network meeting 2017 - Mini workshops with stakeholders around the EU MS - 3 rd ehealth Security workshop 2017 location tbc 15

Next steps for ehealth Security in ENISA Support in the criteria for the identification of Healthcare organisations in the scope of the NISD Raise awareness in the MS through organizing workshops and dedicated meetings Build on the baseline security measures for healthcare organisations as required by the NISD Identify incident reporting mechanisms for healthcare sector Signify security measures for IoT devices/components supporting core healthcare services Establish procurement guidelines for obtaining secure systems and devices in the healthcare organisations Find synergies with stakeholders under the implementation of the upcoming Medical Devices Regulation 16

Join us!! PO Box 1309, 710 01 Heraklion, Greece Tel: +30 28 14 40 9710 ehealthsecurity@enisa.europa.eu info@enisa.europa.eu www.enisa.europa.eu