• There is a right of access to healthcare (= access to the screening examination) on the EU level {1,2}.
• There is no clear right about refusal by the patient, but for patient autonomy, and freedom of choice {3}.
• There are regulations about advertising healthcare (national status) {4–6}, but structured healthcare marketing also takes place and even provides its own journal {7}. However for screening for AAA by ultrasound this should not be relevant.
• Voluntary participation is closely linked to informed consent based on information about the advantages and disadvantages of screening or no screening.
• A false result of a screening test can lead to damage compensation {8}.

AAA screening via abdominal ultrasound is almost free of physical harm, discomfort or pain (Exceptions are the psychological aspect in the case of false-positive results and rupture in the case of a false-negative result). The question about voluntary participation in a screening examination could be answered by turning it around: how could a patient be "forced" to participate in screening? The possibilities are

• by aggressive advertisements by the providers, evoking ‘bad’ emotions
• by inappropriate invitation processes or participation incentives
• by inadequate information about the chances and risks in case of a positive or negative test result

These variations of forced participation act in a subtle, and not in a direct way.

What could the possible harm be for a patient forced into an AAA screening?

• unwanted insecurity, anxiety
• wasted time
• misunderstanding of the process, the sense, or the results of screening

Several pieces of legislation secure the right of access to (best) healthcare {9–11}, but there is little legislation about refusal or forced participation. The law usually takes the view that patients want to have health services available.

Bodily harm is legally forbidden, except for physicians and related occupations in the case of treatment and with the implicit understanding and consent of the patient. {12} Therefore it is more or less the non-refusal or the explicit consensus of the patient joining a (nationwide) screening programme.

The patient's right to non-treatment is discussed controversially (Several legal rules against euthanasia {13}, legislation about genetic testing {14}) and more or less just in the view of death.

For the situation of dementia Gevers {15} states ‘From a legal point of view, however, there is no duty to submit to medical examinations, people have a right to know, and if the patient lacks capacity, a medical examination should only be undertaken if it is in his or her own interest.’

AAA screening is a preventive examination to which an asymptomatic person is invited. Usually the (invited) patient has to ask for the screening (in response to the invitation), so voluntary participation should be properly guaranteed. On the other hand, screening could be somehow insisted on by the general practitioner (GP) or by the radiologist, which could have an element of non-voluntary agreement. The provider of or inviter to the screening  should inform potential participants about the necessity of the screening and the risks of no screening. (For a screening programme on a national level additional adequate information material should be provided.) There is an existing court decision for damage compensation after screening with a false-negative result. (In a case of prenatal screening where a severe handicap of the child was not detected.) {16}

• The basic right to healthcare of good quality includes everybody, even minors or disabled people {19}.
• The decision about minors is legally regulated to be provided by an authorised personal guardian {19–21}.
• No clear legislation exists about the limits and refusal of healthcare. Court decisions about overcoming the guardian or confirming the refusal by the guardian aim to achieve the best balance of benefit for the patient.
• In the case of AAA screening it will be affecting the case of positive screening result with the need of open extensive surgical procedure.

The risk group for AAA screening includes people (men) aged 64+. It does not exclude people of (much) higher age and disability. The risk of mental illness, especially dementia, increases with age, which is likely to result in a higher proportion of incompetent people in this age group who will need eventually to be patronised. Approximately 1% of 65 year olds and more than 50% of 90 year olds have a dementia disorder. {17} The prevalence of severe dementia increases with age, from 6% (for people 65–69 years of age) to almost 25% (for people 95 years of age or older) {18}.

Who decides about screening and following treatment in the case of a positive screening result for a patronised person?

Can there be a legally based general rule? (i.e. cut off for people in nursing homes?)

Can it be ethical to treat everybody?

What might influence the decision of the guardian (inheritance law, co-payments)?

States Parties recognise that persons with disabilities have the right to the enjoyment of the highest attainable standard of health without discrimination on the basis of disability. {19}

There are several court decisions about the treatment of patronised persons. {20}

"...most authorities are of the view that mature minors should be fully informed and be allowed to have a say in health decisions, coaching them with few exceptions. Ultimately, because of the importance of respect for human dignity, autonomy and self determination along with medical disclosure in today's world, it will be recommended that laws in a number of jurisdictions need to be reviewed to reflect the current international trend and amended or replaced as the need might be." (Bello 2010) {21}

The decision about screening for AAA in minors is not the main problem in this field. In accordance with their right to the same healthcare as others they have the right to equal access to AAA screening. The severity of the problem starts with a positive result of AAA screening (i.e. an existing AAA which needs to be treated surgically) and the need to decide about the surgery procedure.

In the case of a decision to refuse surgery there must be proper controls to ensure that the patient's interests have priority, and to assess whether there are interests in possible benefits for the guardian (inheritance law, co-payments), especially if a family member is the guardian and the potential inheritor.

In the best case, the AAA is detected by screening, the repair with a stent is done by endovascular means with minimal invasive surgery and everything is fine. It would make sense to everyone to protect the person from a sudden (painful) death due to rupture.

In the worst case the detected AAA is in a bad location requiring an extensive surgical procedure including extracorporal circulation time. This would raise the question of whether the benefit for the patient (% probability of survival, % probability of rupture) exceeds the harm for the patient (OP risk, burden of intensive care, pain, torture, etc.). {22}

• 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.

•  There are clear regulations on data protection at the European Union (EU) level {29} which are adapted accordingly in the member states.
• Due to good social acceptance of the disease (AAA) and no indications of social stigmatisation (including occupational or financial harm to the patient) data protection is not considered to have higher relevance than is usually stated.
• Existing data protection is appropriate for the patient in the case of AAA screening.

Existing data protection regulations on an international level {30}, are already adapted and integrated in all of the EU countries and in Norway and Switzerland. {31} Theoretically, in cases where no data security is in place, what are the consequences of unprotected data for the patient?

• Harm to dignity: probably not. AAA is not the kind of disease that is socially unacceptable, or has similar consequences.
• Decreased chances in markets: in the job market—probably not for people aged 65 or more; in the private (health) insurance market —(higher contributions, refusal of contract) —probably not at that age.
• Potential for misuse by the provider according to civil law (such as purchased life annuity).

AAA in people aged 65or more probably does not usually influence new contracts with private (health) insurers.

AAA, if diagnosed, is not in special need of unusually high data protection due to stigmatisation. It is a diagnosis that leads to a surgical intervention and has no further chronic implications.

Data networks and data communication between different diagnostic and treatment providers are protected data sources for improved quality management and scientific research, and are included under the data protection regulations.

There are several regulations on the EU and international levels that secure equal access to healthcare in Europe. {33–39} This legislation implies that, in addition to the screening programme (for asymptomatic people in a risk group), usual care (ultrasound examination) is provided for all other people who present with suspicious symptoms.

Special problems in the case of AAA screening

Gender selection

Is it, according to the legal rules of equal access, appropriate to define risk groups for only one gender group (i.e. men aged 64+)?

States Parties {40}shall take all appropriate measures to eliminate discrimination against women in the field of healthcare.{41}

The paper of Perlin 2010 {51} “concludes that we must rigorously apply therapeutic jurisprudence principles to these issues” ( Anm.: relationship between therapeutic jurisprudence (TJ) and the role of criminal defense lawyers in insanity and incompetency-to-stand-trial (IST) cases), “so as to strip away sanist behavior, pretextual reasoning and teleological decision making from the criminal competency and responsibility processes, so as to enable us to confront the pretextual use of social science data in an open and meaningful way. This gambit would also allow us to address—in a more successful way than has ever yet been done—the problems raised by the omnipresence of ineffective counsel in cases involving defendants with mental disabilities.”

Especially in the field of e-health “It is essential to discuss, among others, aspects relating to safety and confidentiality; professional accountability; technical standards relating to digital recording, storage, and transmission of clinical data; copyright; authorization from professional regulatory bodies; and licensing for the remote practice of medicine.”(Rezende 2010) {52}

Because quality is based on education (within the medical profession), physicians' laws alone define legally the principles of medical handling. To assure the quality (i.e. special quality criteria) within a screening process the details can/should be ruled by contracts.

Responsibility:

About neonatal screening Loeber 2008 {53} states several legal aspects from a Singapore (legal) point of view: “no screening programme where such a programme should be (UN Convention for the right of the child); neonate(s) not screened for conditions within the established programme; no consent when it should have been given; error(s) in sampling, analysis, reporting; no follow-up available, error(s) in confirmatory diagnostics and treatment; irregular storage of dried blood spot specimen. Legal issues can be solved easily when responsibilities of parties concerned have been established and documented.”

Prisoners

According to the Council of Europe Committee of Ministers Recommendation (2006)2 of the Committee of Ministers to member states on the European Prison Rules, Part III {42} Health and medical services in prison shall be organised in close relation with the general health administration of the community or nation. (40.1) Prisoners shall have access to the health services available in the country without discrimination on the grounds of their legal situation (40.3).

Does that mean, screening is included? Yes. And if screening is included in this interpretation, is voluntary participation guaranteed? Do they (prisoners) have any choice? This should be the case (legally). Because ultrasound examination of the abdomen does not cause pain, or touch dignity, there should not be any problem. The patients' rights of prisoners are protected separately. {43}

Regionalism

It can be assumed that ultrasound could be provided even in very rural areas, but what about the consequences in the case of a positive result? Is it possible to ensure that people living far from a heart centre are not discriminated against in any way (e.g. by transport costs, waiting times)?

What about equality of services among EU citizens? Health for EU citizens working part time in a country other than their home country and emergency healthcare during holidays is clearly regulated {44}. As a part of the continuing coordination of the systems of social security in the EU {45} an existing EU guideline on patients' rights to cross-border healthcare {46} must be implemented on national levels by 25 October 2013.

Higher age

The selected population for AAA screening should be people (men) aged 64 or more. Can it be assured that within this age group no selection in favour of the younger and against the older members of the group takes place? Can it be legally assured that there is no age discrimination (medically) that is argued on the grounds of the severity of treatment risks (too old for heart surgery, already in nursing home care...).

The limits of healthcare should be implemented as a balance between the right of access and the patient's rights to human dignity, to life, and to their personal integrity, the prohibition of torture and inhuman or degrading treatment or punishment; and respect for private and family life. {47}

Quality:

"The most common allegation among family medicine closed claims was diagnostic error, and the most prevalent diagnosis was acute myocardial infarction, which represented 24.1% of closed claims with diagnostic errors". (Flannery 2010) {48} “Aortic aneurysms and dissections, although relatively infrequent as clinical events, represent a substantial MPL risk because of the high percentage of paid claims (30%) and the very high average indemnity payment of $417,298.”(in USA, Anm.) (Oetgen 2010) {49}.

The question for screening is: should the quality level of screening (the diagnostic ability of the provider) be secured legally?

The World Medical Association Declaration on the Rights of the Patient {50} includes the right to medical care of good quality, and there are several patient rights that implement the issue of quality. But is quality claimable?

• The basic right to state of the art healthcare and the declarations for gender equality, prisoners, disabled, regional equalities can be interpreted as the expanded rights to appropriate equal preventive examinations. In terms of screening this is fulfilled if the screening criteria (highly accurate, acceptable, cost-effective) are reached.
• In the case of AAA screening, a positive result requires a high-level structure for complex heart surgery that can serve the epidemiological burden. Questions of reimbursement by the national health system for necessary treatment abroad are decided by the courts.
• Problems with health structures exemplified by, for example, waiting lists or lack of resources must be solved at a health system or governmental level

A screening programme without the infrastructure to treat the detected diseases appropriately (and with equal access) would be senseless. Does the patient have the right to be treated in case of a positive screening result?

The EU considers that early detection procedures and techniques should be researched more thoroughly before being widely applied in order to guarantee that their use and application is safe and evidence-based; therefore, it is necessary that this research leads to unambiguous and evidence-based recommendations and guidelines. {54} This was written in the context of cancer care and prevention, but it can be assumed that this is a basic opinion, which is therefore also valid for other screening activities. Further, the opinion of the EU can be interpreted as requiring the defining of clear and transparent goals for the screening programme, which should be communicated to the public. {55}

Lack of resources

What about lack of resources for treatment (not enough heart surgeons)?Is treatment abroad required? How is the waiting list prioritised there?

Should the screening programme for AAA be initiated if adequate resources for treatment of positive findings are not clearly available?

Waiting lists

Are transparent waiting lists required? Are there any influences on waiting lists (e.g. corruption)? How could that be solved? Is there any necessity to influence the waiting list system by law? Is there any necessity to define a (legal) cut-off for some people who would not benefit from AAA screening (heart surgery, rehabilitation) even in the selected age group?

A study about long-term care reports that ‘most variability in advance care planning decisions was the result of differences among community-based long-term care providers (64%) rather than consumers' situational features.’ The authors ‘highlight the need for consistent educational programs regarding the role of the ... provider.’(Baughman 2011) {56}

The court decision {57} about treatment abroad states several conditions for reimbursement by the national health system. Basically it is different in terms of (AAA) screening, unless there are huge waiting lists for the screening examination, which does not seem very likely.

Structure and resources must be provided appropriately. EU action, to complement national policies, should be directed towards improving public health, and preventing physical and mental health illness. The EU and the Member States should foster cooperation with third countries and competent international organisations in the sphere of public health. {58} Member States shall be responsible for the organisation and the delivery of healthcare. Member States shall facilitate development and functioning of a network connecting the national authorities responsible for health technology assessment. {59}