Security and Risk Assessment in GDPR: from policy to implementation

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1 Global Data Privacy Security and Risk Assessment in GDPR: from policy to implementation Enisa Workshop Roma - February 8, 2018 Nicola Orlandi Head of Data Privacy Pharma

2 Nicola Orlandi Nicola Orlandi is currently the Head of Data Privacy Pharma in Novartis. In this role he s partnering with divisional business to enable growth, productivity and innovation, implementing privacy controls and considering data privacy requirements as well as business needs. 2

3 A new era for the use of health data The Health Care Sector is processing different categories of personal data and needs to increasingly use health data to improve patient outcomes Pharma is also accessing an unprecedented depth and breadth of health data. DIGITAL MEDICINE REAL WORLD EVIDENCE SECONDARY USE 3

4 Digital solutions improve health outcomes for patients CLINICAL TRIALS Improvement of trial administration and enhancement of patient experience and outcomes PATIENT EXPERIENCE aid in patient care and help in identifying and delivering on big trends PROVEN OUTCOME Collaboration to drive continuous innovation from insights through the assessment of deidentified patient data 4

5 ...with advantages for all stakeholders in the system Patients Payers Physicians Scientists Policy makers More personalized treatment approach Better therapeutic outcome Enable outcome based pricing Verify cost offset across budget lines Decisions supported by richer data Best practices identification Identify new disease pathways Accelerate development of new therapies Reduce waste in the healthcare system More secure and sustainable healtcare 5

6 Beyond the pill a new use of information will improve therapies Patient John Physician visit Diagnosis and prescription Pharmacy Physician diagnoses Sensor monitors pill intake and cancer and prescribes biomarkers indicating oral cancer drug; informs gastrointestinal Sensor detects infection, early signs of John about Beyond patch the gastrointestinal measures temperature, infection, alert sent Pill solution John to John scans answers with standard immediate barcode Patient countermeasures, Reported to to Outcomes alert sent to John picks up download on physician, side effects physician app, daily; app contacts John drug from gets sends and on-boarding John prescribes advice medication best to pharmacy, bar call nutrition manage from and side medication effects code on package telenurse; reminders John to download app puts on on sensor patch Physician intervention Continued treatment John is back on stable treatment Alert Pick up home setting Log-on Home monitoring and patient reported outcomes Solution Elements Adherence/ side effect App Sensor 2.0 Artificial Intelligence algorithm 6

7 Autologous therapy and chain of identity In an autologous immunocellular therapy, maintaining an accurate Chain of Identity is essential to patient safety. Data Privacy plays also a relevant role when defining a proper measures creating a safe environment around patients data. autologous: cells or tissues taken from and returned to the same individual 1 Reference: 1. National Cancer Institute Dictionary of Cancer Terms. Accessed March 9,

8 Digital technologies and responsible use of health data... Digital and new data sources: Social media, apps, websites, blog Use of data: Scientific research Data access Data sharing Transformation and opportunity Data Subject s autonomy Transparency Safe environment Data security 8

9 Individual and societal context Digital and new data sources: Social media, apps, websites, blog Balance between individual and societal expectations and interests Use of data: Scientific research Data access Data sharing Data Subject s autonomy Transparency Safe environment Data security 9

10 What do we need to build and demonstrate Digital and new data sources: Social media, apps, websites, blog Use of data: Scientific research Data access Data sharing TRUST Data Subject s autonomy Transparency Safe environment Data security 10

11 What do we need to build and demonstrate Digital and new data sources: Social media, apps, websites, blog Use of data: Scientific research Data access Data sharing TRANSPARENCY Data Subject s autonomy Transparency Safe environment Data security 11

12 An holistic strategy and governance in line with GDPR rules will help to manage data properly... Risk Assessment Risk Management Enable responsible data use Create value from personal information and enable innovation Maintain public trust Clear strategy, rules and guidelines Technical and organizational governance Dedicated tool and safe environment 12

13 ...and will also support scientific research and further use of data A transparent and reliable approach will also support further processing of health data for scientific research if a dedicated governance is in place with appropriate safeguards: technical and organizational measures (e.g. pseudonymization) protecting rights and freedoms of individuals and ensuring respect of the principle of data minimization 13

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