[The practice guideline 'Pregnancy and puerperium' (first revision) from the Dutch College of General Practitioners].
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Biomedical subjects
Publications and source records attributed to H D Roscam Abbing.
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An electronic patient file is expected to contribute to individual health care, as well as to policy goals. For acceptance by doctors and patients, some conditions have to be fulfilled. Among them is the appropriate specification of the right of the patient to medical secrecy and privacy. Reference is made to new legal requirements (Wet Bescherming Persoonsgegevens (Act on the protection of personal data)), which e.g. regulate when access to personal medical data is lawful, when consent is required and in what form, in addition to a number of other conditions. The current information and communication technology must not be allowed to dictate the possibilities and limitations of legally applicable standards, but the technical implementation of the electronic patient file must be made to suit and assure the legal standards of medical professional secrecy and patient privacy. Otherwise the advantages of an electronic patient file will be out-weighed by patients withholding important information from their physician and by their being less inclined to consent to their data being used for e.g. scientific investigations.
When considering electronic patient files some conditions have to be respected. They are, in particular, confidentiality and informed consent by the patient. Furthermore, undue access to data can be prevented by PET, access authorization and the like. Patients should be allowed to exert control over their medical data. National and international good privacy practice guidelines should be drawn up in order to avoid privacy-erosion.
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The object of reviewing medical scientific research in humans is to offer guarantees against, especially, violations of physical integrity and privacy. Since the scientific interest is a matter of first importance, the research has to be checked for its reasonableness and for the test subject's consent. Omission of these checks in case the risk or stress to be expected is slight is contrary to these criteria. Reversion of the sequence of informed consent and randomization is contrary to the requirement of consent. Free, informed consent may be assumed if in a trial with a control group the test subject is informed beforehand about the study design and the risks, but is not told if he is to receive a standard therapy, a placebo or a test medication.
Clinical practice guidelines are directions for medical doctors on the action to be taken in a given situation, thus standardising medical performance as regards content. The implementation of clinical practice guidelines (CPGs) is stimulated by government and health care insurers. Court decisions frequently refer to these guidelines. From a medical and legal perspective, the implementation of CPGs in daily medical practice has advantages (e.g. they contribute to best medical practice as well as to the quality of information to be provided to the patients), but also disadvantages (they may replace professional responsibility and may put cost containment over professional autonomy). CPGs may contribute to quality of care provided they are applied flexibly and responsibly.
One law in the Netherlands (BOPZ; Bill on Compulsory Admission to Psychiatric Hospitals) regulates the involuntary institutionalisation of psychiatric patients who are considered a danger to themselves or to society, due to their psychiatric disorder. Another law (WGBO; Decree on the Medical Contract) regulates consent procedures for somatic treatment of patients who are incapable of an autonomous decision. Involuntary institutionalisation according to BOPZ should not be used to accomplish somatic treatment without consent of the patient, as this may deprive the patients involved of their fundamental right to refuse treatment.
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Currently, there is an increasing tendency to convert patients' rights into duties. At least three areas can be identified: The tendency of the health care provider to claim duties of the patient in the doctor-patient relationship; the trend to stipulate conditions when patients are in need of health care delivery; and the evolution towards the formulation of patients' legal duties when third-party interests are involved. The societal tendencies to convert legal rights into legal duties, to require counter-services from the patient and to control patients' behaviour, limit patients' rights to self-determination and essential human rights in health care. Ultimately, intervention through legislation might be necessary.