Exploring patient participation in reducing health-care-related safety risks

Exploring patient participation in reducing health-care-related safety risks
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Information about health and safety
Patients are more likely to be involved in their health care when thoroughly informed (5),
enabling them to make appropriate health decisions. Legally, the right to information
about one’s own health is part of the right to informed consent (30) (Table 6.1).
According to Portuguese law, health information is any information directly or indirectly
linked to the present or future health status of a person, either living or deceased,
including clinical and family history (40). Article XIV of the Basic Law on Health, which
regulates patients’ rights and duties, states that a patient has the right to be informed
about their condition, possible treatment options and the possible evolution of the
condition (31). The inclusion of the right to know the risks and secondary consequences
of treatment, as well as the risks and consequences of refusal of the intervention or of
different options, should also be addressed, as suggested by the ERS (41).
The Portuguese legal framework (30) states that patients’ access to their personal health
data should be granted through an authorized physician and cannot be used for any
purpose other than health care and research (30,31). The Health Systems Observatory
objects to the fact that patients can only access their personal data in the presence of a
physician (42).
The duty of health care professionals to explain the diagnosis, intervention/treatment
and consequences to the patient is indicated in the Portuguese penal code (43), except
for instances when this information can represent danger or harm to the patient (Article
1.157). The right not to know is not specified in Law No. 12/2005 of 26 January 2005
on Personal Genetic Information and Health Information (40), but is set out in the
European Charter of Patients’ Rights (27), Article 4, which states that “a patient has the
right to refuse information about his or her health status”.
Informed consent and safety
Informed consent is one of the many processes used to ensure that patients are engaged
in their own health care, especially in relation to surgical procedures. Seeking informed
consent offers a “prime opportunity for patient education, engagement and involvement
that can lead to better, safer and more effective care” (44).
The Centre for Biomedical Ethics and Law of the Catholic University of Leuven
states that the right to informed consent appears in different ways in Portuguese law
and sometimes with different legal bases (30) (Table 6.1). Information provided to
patients is usually verbal (41). Portuguese law does not require written informed consent
except for the following laws: Law No. 46/2004 of 19 August 2004 (Clinical Trials
with Medicinal Products for Human Use) (45); Law No. 12/2005 of 26 January 2005
(Personal Genetic Information and Health Information) (40); Law No. 32/2006 of 26
July 2006 (Medically Assisted Procreation) (46); and Law No. 22/2007 of 29 June 2007
(Harvest and Transplant of Human Organs and Tissues) (47).
The ERS suggests the implementation of a legal framework that changes the nonobligatory
nature of written informed consent (41). According to the penal code (43),
consent can be freely revoked and any treatment performed without previous consent
of the patient can be sanctioned. In the field of informed consent, the Direcção Geral