1 Enabling Technology To Advance Health - Protecting Individual Rights- Are We Walking The Talk? Crystal Sharp*, Femida Gwadry-Sridhar I-THINK Research, Lawson Health Research Institute London, Ontario, Canada

2 Enabling Technology To Advance Health - Protecting Individual Rights - Are We Walking The Talk? 1) Enabling Technology : Balancing research use vs protecting privacy; health data ownership 2) Protecting Individual Rights: Public policy & legislation; informed consent; entities exempt from health laws 3) Are We “Walking the Talk”? PCHRs; Public Perceptions of EHR Systems; European Data Protection Directive; Connecting for Health 4) Summary and Conclusions

3 Enabling technology Balancing research use – promise of ehealth Ehealth makes possible: Improved patient safety – continuity of care Drug discovery Utilization review Patient-centred care Accurate and efficient flow of medical and billing information between providers

4 Enabling technology Balancing research use: privacy, ownership rights …..but it also raises concerns about: privacy and confidentiality of patient data, and individual rights of ownership as the electronic records maintained by physicians and hospitals will be only one component of a larger Web- based information system.

5 Enabling technology Balancing research use: policy Policy in safeguarding privacy: balancing individual privacy considerations against the accessibility of health information; delineating the required and permissible purposes for which health information can be collected, stored, transmitted, used and disclosed; and negotiating the regulatory boundaries of new technologies.

6 Enabling Technology Public policy; Legal complexities Legal complexities in balancing: rights of individuals and their expectations of privacy autonomy and authority of health professionals competition in health care product markets. jurisdictional powers over health care quality, financing and accountability. Rosenbaum,S. & Painter,M. Assessing Legal Implications of Using Health Data to Improve HealthCare Quality and Eliminate Health Care Disparities The Robert Wood Johnson Foundation.

7 Enabling technology Health data ownership: Why does it matter? Accountability: Unlike paper records, e-health records are easily shared, stored, transferred, accessed, linked. Data has value: Who benefits? Who grants access? Who administers? Intellectual property from products developed using health data

8 Protecting Individual Rights Privacy Laws Privacy laws define personal information as identifiable information about an individual and require that individual’s consent before such personal information can be collected, used or disclosed. Data must be “anonymized” for research

9 Protecting Individual Rights Privacy Laws -- Problems Informed Consent can be problematic: May affect completeness and validity; systematic bias Can hamper retrospective research Institutional Review Boards may not have the necessary expertise to assess ehealth issues Patients may feel pressured to consent With high-performance computing can match and combine data from multiple databases that offers the possibility of “re-identification”.

10 Protecting Individual Rights Entities exempt from existing health laws In Canada prescription data is routinely sold or transferred to commercial data brokers without the informed consent of patients or physicians[1]. Online data stored outside the health care systems are not subject to HIPAA laws[2]. [1] Kosseim,P. & El Emam,K. (2009) Privacy Interests in Prescription Data, Part 1. IEEE Security & Privacy -72. [2] Steinbrook, R (2008) Personally Controlled Online Health Data –The Next Big Thing in Medical Care? N Engl J Med, 358:16, Apr 17, 2008.

11 Are We Walking The Talk? Personally Controlled Health Records (PCHRs) Google Health; Microsoft HealthVault allow patients to store and manage their personal medical data online. Patient-centred care Hospitals (Beth Israel Deaconess Hospital, Cleveland Clinic, Mayo Clinic) are partnering with these services and putting their patient records online.

12 Are We Walking The Talk? PCHRs (continued) Google Health and Microsoft Health Vault are not covered by current privacy legislation: they are not health provider organizations.

13 Are We Walking The Talk? Public Perception of EHR systems New Zealand Study* found that for consumers to accept EHR systems: The security of the EHR system has to be of the highest level and constantly monitored and updated, and Involvement of the health consumer in the ownership and maintenance of their health record needs to be more proactive. *Chhanabhai,P. & Holt,A. (2007) Consumers are ready to accept the transition to online and electronic records if they can be assured of the security measures. MedGenMed. 9, 8.

14 Are We Walking The Talk? Public Perception of PCHRs (continued) Community-based study of perceptions of PCHRs* found: Low familiarity with PCHRs, along with High expectations of the PCHR capabilities Advocated need for: Improved health and technology literacy; Responsibility for ensuring accuracy and integrity of health information across distributed data systems, Improving understanding of confidentiality and privacy risks. *Weitzman,E.R., Kaci,L., & Mandl,K.D. (2009) Acceptability of a personally controlled health record in a community-based setting: implications for policy and design. J Med Internet. Res. 11, e14.

15 Are We Walking The Talk? European Data Protection Directive ………“While the widely applauded principles of the Directive will remain as a useful front-end, they will need to be supported by a harms-based back-end in order to cope with the growing challenge of globalization and international data flows…” Excerpt from: Rand Health Review of the European Data Protection Directive:

16 Are We Walking The Talk? Connecting For Health The Common Framework: “…..is like a nationwide set of traffic rules that enable specific pieces of health information to travel when and where they are needed…” “….is the minimum necessary set of rules or protocols for everyone who shares health information to follow.”

17 Enabling Technology To Advance Health - Protecting Individual Rights- Are We Walking The Talk? Summary and Conclusions Existing legislation, institutional oversight, security and monitoring inadequate Initiatives like “Connecting for Health” are important steps forward We all have a role to play in monitoring, educating, ensuring accountability and building trust

18 Enabling Technology To Advance Health - Protecting Individual Rights-Are We Walking The Talk? Crystal Sharp, Information Specialist Femida Gwadry-Sridhar, Director I-THINK Research Lawson Health Research Institute London, Ontario, Canada