Statement 'the use of patient-related information in medical research and the health system'

• Published in: Pharmacoepidemiology and drug safety 2000-12, Vol.9 (7), p.581-585
• Main Author: Central Ethics Commission of the German Medical Association
• Format: Article
• Language: English
• Subjects: Bioethics; Confidentiality; Delivery of Health Care - legislation & jurisprudence; Ethics, Medical; Germany; Humans; Informed Consent; Medical Records Systems, Computerized; Research - legislation & jurisprudence
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/pds.543

Patient‐related information is regularly recorded in surgeries and hospitals. The health system produces such ‘person‐related health data’ in astronomical numbers. Millions of data are entered into and processed by the computing systems of many different institutions. They are used for the treatment of patients and the calculation of health fund benefits and in addition, given a systematic and methodologically controlled evaluation, they can be used to detect health risks, assess more accurately the consequences of risks and diseases, compare the benefits of different therapies, or rank health care goals. Since health data are person‐related their recording and use are subject to the consent of the person in question. Besides, the information which the patient provides or which is established regarding the patient, is protected by the confidentiality to which all doctors are held; if it is passed on to calculate health benefits it is protected by the confidentiality of social security data. Beyond this moral and legal protection the use of person‐related health data requires explicit legal justification. In view of the multitude of uses which the current level of data processing affords, no legal regulation can determine every possible instance comprehensively and definitively in advance. Rather, a moral and legal evaluation of each instance is needed. It is not without reason that the data protection laws contain more or less comprehensive general clauses and indeterminate legal concepts. The Central Ethics Commission at the German Medical Association (Bundesärztekammer) has put out a statement on these matters. It asks the legislature to improve the protection for individuals with respect to the use of patient data for research in medicine and the health system in accordance with EU‐Directive (No. 95/46/EG of 24 October 1995). Moral and legal problems occur mainly when, for objective reasons, the consent of the persons in question cannot be obtained, yet the further use of the data is important in order to improve the care of the patients. The Central Ethics Commission suggests the establishment of independent bodies along the lines of ethics commissions to undertake the necessary judgments between individual protection and the importance of the purpose for which the data are to be used. It further argues that if used in medical research or the health system the data are given the same degree of protection as they were by the doctor to whom they were fir