1. EUropean Best Information through Regional Outcomes in Diabetes Privacy and Disease Registries Technical Aspects Peter Beck JOANNEUM RESEARCH, Austria 2° EUBIROD Meeting Brussels 22-23 January 2011

2. www.eubirod.eu Factors = Key Elements of Data Protection  The key elements of data protection (FACTORS) identified in the management of diabetes registries are as follows: A1. Accountability of personal information A2. Collection of Personal Information A3. Consent A4. Use of Personal Information A5. Disclosure and Disposition of Personal Information A6. Accuracy of Personal Information A7. Safeguarding Personal Information A8. Openness A9. Individual Access to Personal Information A10. Challenging Compliance A11. Anonymization Process for Secondary Uses of Health Data

3. www.eubirod.eu Introduction to Cryptography Conventional Cryptography

4. www.eubirod.eu Introduction to Cryptography Public Key Cryptography

5. www.eubirod.eu Introduction to Cryptography Digital Signatures

6. www.eubirod.eu Introduction to Cryptography Hash Functions and Digital Signatures

7. www.eubirod.eu =facilitate establishing whether a public key truly belongs to the purported owner =a public key + owner identity information  signed together Introduction to Cryptography Digital Certificates

8. www.eubirod.eu Public Key Infrastructure Certification Authority – Issue certificates Verify identity – Keep a list of (valid) certificates – Certificate revocation Web of Trust (PGP)

9. www.eubirod.eu Security Key Concepts Communication Security Services Authenticity Authorization / Access Control Integrity Confidentiality Non-Repudiation

10. www.eubirod.eu Security Key Concepts Authenticity = verifying a claim of identity e.g. Airport: I am John Doe, I want to fly to Brussels  Passport something you know, something you have, or something you are username password (cryptographic) key challenge-response biometrics Protection mechanisms TAN

11. www.eubirod.eu Security Key Concepts Authorization / Access Control =Apply and configure mechanisms to enforce administrative policies Protection Mechanisms Access Control List + Role based access control  (e.g. file system, DBs, Web-Apps) Capabilities Data input Physician Local Administrator Global Administrator Administer Centers Import Data Administer Staff Create Reports Execute Analyses Enter Data Sheets Administer Patients Login www..at

12. www.eubirod.eu Security Key Concepts Integrity =Avoid undetected modification of data Protection mechanism – message integrity Message Digests (Hashing) Protection mechanism – communication stream integrity Sequence Numbers Time Stamps

13. www.eubirod.eu Security Key Concepts Confidentiality =Prevent the disclosure of information to unauthorized individuals or systems Protection mechanism symmetric or asymmetric encryption

14. www.eubirod.eu Security Key Concepts Non-Repudiation =implies that one party of a transaction cannot deny having received a transaction nor can the other party deny having sent a transaction Protection mechanism digital signatures  time stamp, notarization

15. www.eubirod.eu Safeguarding Data How can you protect your data and software? Use and maintain anti-virus software and a firewall Regularly scan your computer (viruses, spyware…) Keep software up to date Evaluate your software's settings Avoid unused software programs Create separate user accounts Establish guidelines for computer use Use passwords and encrypt sensitive files Set up and follow corporate policies for handling and storing data Dispose of sensitive information properly Follow good security habits

16. www.eubirod.eu Anonymisation I =Make it impossible to establish or indicate who or what (someone or something) is remove any direct identifiers (SSN, name, DOB…) replace direct identifiers by indirect patient IDs (Pseudonymisation) – requires a trusted third party  reversible pseudonymisation (encryption with a key)  irreversible pseudonymisation (hash, …)

17. www.eubirod.eu Anonymisation II ensure that any combination of data cannot identify an individual – not easy, especially for sparse data  k-anonymity use aggregated data only (no individual data sets) – all analyses have to be done in line with data source – further calculatons not possible

18. www.eubirod.eu Data flow throgh Trusted Third Party (the case of the Disease Management Program in Austria) Physician officeHealth Information Network Social Insurance Internet DMP Medical Data Repository Physician Software Browser Terminal Stand-alone Client Data Centre GINA e-card Central System Social Insurance online Portal Pseudonymi- sation centre DMP Administration Software Documentation Prepare Data: Check, Split Administrative and Risk Data Clinical Data: Sign+Encrypt Data Transmission Administrative + Risk Data SSN Risk Data SSN Risk Data Clinical Data SSN Clinical Data Pseudo- nym SSN Clinical Data Pseudo- nym Sign+ Submit Risk Data Clinical Data

19. www.eubirod.eu Local Aggregation of Data (the case of the BIRO Reporting Architecture) BIRO Central Reporting Partner Work Conversion Source Dataset Local BIRO Database Engine Statistical Analysis Aggregated Data „Statistical Objects“ |A|12|1|5| |B|18|2|6| |C|16|1|4| Sender Central BIRO System Authenticated, Signed & Encrypted Communication Regional Data Processing Regional Register BIRO Database Receiver ReportBIRO Central Engine

20. www.eubirod.eu Tanks for your attention!