Result card

  • LEG6: Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?
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Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?

Authors: Pseudo108 Pseudo108

Internal reviewers: Pseudo99 Pseudo99

  • Appropriate counselling and information is legally regulated and has to be provided {23}.
  • The provider of the healthcare service has a duty to find an informed consent (treatment contract) and to document it.
  • Medical/information errors are regulated according to penal law and are sometimes difficult to elaborate {27}.
  • In the case of AAA screening appropriate information has to be secured, especially about the consequences of a positive result. Part of appropriate care is adherence to recommended follow-up examinations. Patients' adherence is not regulated legally, except on a contract level.

AAA screening via abdominal ultrasound is an easy, painless, accepted examination. The patient can agree to screening effortlessly. However, dealing with the consequences if the result is positive is more difficult.

According to the Charter of Fundamental Rights of the European Union {23} the regulations about Human Dignity, Right to Life, Right to the Integrity of the Person, Prohibition of Torture and Inhuman or Degrading Treatment or Punishment, Respect for Private and Family Life, Protection of Personal Data lead to following patients' rights:

  • the right to self-determination
  • the right to sufficient information and to give informed consent (and refusal by the patient, even refusal of the information)
  • the right to treatment or medical help
  • the right of discharge from hospital (except after executive admission)
  • the right to secrecy by the physician (except if there is an infection risk)
  • the right of access to medical records
  • the right of equity

On a national level some extended rights/regulations are in place, such as:

  • the right to refuse autopsy {24}
  • the right to refuse to be a transplant donor {25}

The legal basis between the physician (medical provider) and patient is the treatment contract, which includes information, documentation, carefulness and appropriateness duties from the physician (medical provider) and agreement from the patient. Compliance is not described as a duty of the patient, but one can interpret informed consent as a willingness to cooperate.

For adverse outcomes due to a medical intervention three dimensions according to the penal law are defined:

a) information error— no/false/insufficient information

b) treatment error

c) medical malpractice

In the case of a medical error patients can go either to the arbitration board or to court. The proof of fault is often difficult:

  • How can it be proved whether the physician provided wrong/insufficient information or did not understand themselves? According to several studies many physicians fail to interpret statistics about relative and absolute risk properly {26}.
  • How can it be proved whether the error is a complication or a mistake? An article about the results of expert decisions about medical errors taken to the arbitration board found that 6% (444/7201) were accepted medical errors with insufficient information but no treatment error and 29% (2127/7201) were accepted medical errors with insufficient information and causality {27}.

Ultrasound screening for the detection of an AAA brings the possibility of positive test results that do not need urgent treatment due to the relatively small size of the aneurysm. In such cases the patient should be informed that they should return for repeated control ultrasound examinations to observe the development of the aneurysm. Leffler 2011 {28} states that lack of adherence to recommended follow-up evaluation increases risk for adverse health outcomes and medical or legal issues for the topic of colonoscopy and recommends a simple protocol of letters and a telephone call to patients to improve patient adherence to medical recommendations.

Pseudo108 P Result Card LEG6 In: Pseudo108 P Legal aspects In: Jefferson T, Vicari N, Frønsdal K [eds.]. Abdominal Aorta Aneurysm Screening [Core HTA], Agenzia nationale per i servizi sanitari regionali (, Italy; 2013. [cited 28 May 2023]. Available from: