Tuesday, February 7, 2012

[EQ] Legal frameworks for eHealth

Legal frameworks for eHealth

Based on the findings of the second global survey on eHealth

WHO World Health Organization
GOe - Global Observatory for eHealth Series, v. 5, 2012

Available online PDF [89p.] at: http://bit.ly/xu0VNC


“…….Given that privacy of the doctor-patient relationship is at the heart of good health care, and that the electronic health record (EHR) is at the heart of good eHealth practice, the question arises: Is privacy legislation at the heart of the EHR?


The second global survey on eHealth conducted by the Global Observatory for eHealth (GOe) set out to answer that question by investigating the extent to which the legal frameworks in the Member States of the World Health Organization (WHO) address the need to protect patient privacy in EHRs as health care systems move towards leveraging the power of EHRs to deliver safer, more efficient, and more accessible health care.

The survey began with a question on the existence of generic privacy legislation followed by questions to establish if specific rules had been adopted to address privacy in EHRs. A series of questions followed pertaining to the way in which privacy is addressed in transmittable EHRs and patients’ rights to access, correct, and control the use of the EHR.


The investigation ended by broaching the issue of privacy protection in secondary uses of data contained in EHRs, such as for international research purposes. In the present report the analysis of the survey responses is preceded by an overview of the ethical and legal roots of privacy protection. Focusing on the ethical concepts of autonomy, beneficence, and justice, the report reminds the reader of the early recognition of the duty of privacy in the Hippocratic Oath and goes on to consider how that is reflected in international binding legislation such as the United Nations Declaration on Human Rights and the European Union Data Protection Directive, as well as non-binding international codes of practice…..”


Table of contents

Executive summary

1.         Introduction

1.1 Is privacy a culturally dependant concept?

1.2 Is respect for privacy important in the uptake of eHealth?

1.3 Privacy or confidentiality of electronic health record EHRs - a note on terminology

2.         The ethical and legal aspects of privacy in health care: a literature review

2.1 Privacy of health related information as an ethical concept

2.2 The protection of privacy of health related information through law

2.3 Binding international law on privacy of health related information

The Universal Declaration of Human Rights
The European Convention on Human Rights

European Union Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data

2.4 International non-binding agreements

Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data
Council of Europe Recommendation No. R (97) 5 on the protection of medical data

WHO: A Declaration on the Promotion of Patients' Rights in Europe

2.5 National law on privacy of health related information .

Use of EHRs in Brazil

Legislative responses to EHRs in the USA


3.         Analysis of survey results

3.1.       General privacy legislation

3.2 EHR privacy legislation

3.3 Legislation to regulate the sharing of health related data for patient care

3.4 Legislation on patient access and the control of EHRs

3.5 EHRs for research

4.         Conclusions

4.1 Building trust

4.2 Making data work: expanding the uses of EHRs

5.         References

6.         Appendix 1. Methodology of the second global survey on eHealth


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