Ethical and deontological foundations of the medical record: Whose is the medical record?
Gonzalo Herranz
department of Biomedical Humanities , University of Navarra, Spain
Ethical and deontological foundations of the medical record: Whose is the medical record?
In: Cycle of Ethics and Medical Humanities , high school Official high school of Physicians of Zaragoza, Spain.
Zaragoza, October 22nd, 2002
ethical-deontological requirements of the hc
Whose medical history (hc) it is is a complex question, capable in itself of provoking lively debates such as the one we are going to have this afternoon. It is a problem that, for the time being, we will not be able to solve, since there are many customs to be changed, deontological and legal standards to be agreed upon and refined, and many contenders competing to own the hc or, at least, to determine its functions and uses. Whoever owns it and can govern its content, its applications and its destiny, would enjoy great power in health management .
The task entrusted to me by the organizers, to deal with the topic from its ethical-deontological point of view, is not an easy one, especially if I follow their mandate not to go into peripheral issues, but to explore its foundations. Not much has been published in recent years on the ethics of hc ownership. This contrasts with the abundant production of legal norms, court rulings and legal reflections, all of which have been conceived and presented in the core topic of rights and law. Moreover, not all codes of ethics and medical deontology in our environment have been sufficiently innovative in this respect.
It seems to me that, in order to introduce the subject, I must first refer to some ethical-deontological requirements of hc, which are of interest for our problem, to immediately go on to answer the question of who and to what extent is the ethical owner of hc, to whom does the factual and intellectual content of hc ethically belong, who is the material support of hc, who are those who are morally responsible for it. Having briefly considered these aspects, I will propose some very brief and modest tentative conclusions.
ethical-deontological requirements of the hc
To begin with, I will take a moment to vindicate the primacy of the ethical aspect of hc, since in recent years the legal attributes of hc have been weighing more heavily in the physician's mind than its ethical elements.
It is said that almost all disciplinary proceedings and lawsuits against physicians are based on the CCH. Consequently, the notion has spread that the hc is, above all, a legal document, which in a lawsuit can serve as both a defense and a ruin for the physician.
Reducing hc to a legal piece obscures three important ideas:
The first, which has to do with the relationship between patient and physician, is that the hc is, and will always be, an instrument created for the best care of the patient, not to protect the physician from possible accusations. The hc is valid only and to the extent that it fulfills this primary purpose. Any QC that simply sample that the patient has received competent and respectful care is good in all respects, even in the legal sphere. The hc is the natural record of the patient/physician relationship, and, as such, it is also the best and most convincing witness to the physician's performance, whether correct or not.
The second idea has to do with the relationship between physicians among themselves. There are few hCs made and carried out by a single physician and for his or her exclusive staff use. In hospitals and outpatient clinics, the hc is now shared by many healthcare professionals, physicians and non-physicians alike. The hc is, therefore, a vehicle of information between those who attend and serve the same patient. Therefore, the requirements of good hc are rigor, order and authenticated responsibility of the data and comments included in it. Good hc is written with good handwriting, clarity of substance and conciseness of form: only in this way is it immediately legible and usable by all.
The third idea refers to the physician's relationship with the community. An HCP file of a health care facility is the touchstone on which the skill of the physicians, the efficiency of the programs, the reality of the services provided, the ethical maturity of the institution must be evaluated. The hc file is also an essential means of epidemiological research and a final written request validation of clinical guidelines. All these functions are not immediately aimed at the good of the individual patient, holder of the hc, but place the hc at the service of society and science.
In many of these uses and purposes, technological procedures for the production, transmission and conservation of data and information play an increasingly important role. These new techniques cannot disregard the ethical requirements of hc or the deontological imperatives that seek to safeguard confidentiality or guarantee data security.
In summary: from an ethical perspective, the question "Whose is hc?" obliges us to pay attention to the ethical requirements of the three major referents (patients, physicians, society) on which professional ethics is based, since it is they, by different degree scroll, who have ethical interests in the subject.
The hc has a first ethical owner: the patient. For many reasons, the patient is the ethical owner of the hc. The information contained in it is initially composed of the data that the patient refers to himself, spontaneously or in response to the physician's questions. The destiny of this information revealed to degree scroll of confidentiality is, to all intents and purposes, strongly conditioned by the duty of medical secrecy: the patient dominates them with his privacy.
The hc belongs to the patient by virtue of the physician's duty of truthfulness. Out of respect for the patient, who owns the hc, the physician's entries in the hc must be truthful. It is ethically unacceptable to enter false or fictitious data in the hc, or to modify previous annotations, eliminating them or replacing them with false ones, with the intention to deceive. The misleading manipulation of the hc is a serious deontological and criminal offence, an attack on the patient, which can constitute, if done with malice, the crime of document falsification. Lack of truthfulness has nothing to do with the segmentation of the hc, which I will attention later.
We do not think about it enough: hc data are personal data , i.e. they share in the dignity and predicament of the human person. All these data, from laboratory findings to interconsultation reports, are located in the powerful gravitational field of the patient's humanity, a circumstance that makes them all the more delicate, sensitive and worthy of greater respect the closer they are to the innermost core of the person. I know that I exaggerate, that I dramatize -I do so with pedagogical intent- when I affirm that a mature sense of what ethical respect is should provoke in every physician the living and tangible sensation that there, in the hc, a person is morally present. It is an almost physical presence, symbolized by the name. The patient's name personalizes the hc. This is why modern ethical standards authorize the use of hc in research, auditing or teaching as long as the corresponding ethical committee is satisfied that they have been anonymized.
Our behavior would then be more refined. If we realized that a human being is present in the hc, that he sees and feels what we do with it, our behavior would be more humane. Perceiving the patient's presence in the hc has many consequences.
It gives us a better understanding of the care with which the hc is to be treated, that is, whose patient the hc is. To begin with, with what is written in it. Since the hc belongs to the patient, when writing the hc we must listen to him attentively, not overwhelm him or silence him, and not judge him.
As the owner of the hc, the patient has the ethical capacity to set limits on what is written about him. He can say: "Doctor, do not put what I have just told you in my history". And the physician, out of respect for the patient's dignity, privacy and autonomy, will comply with this wish. And he can demand that the hc be well ordered. The German Code is not very demanding in subject of hc, but it points out that the duty of a well-ordered hc is imposed on the physician as a basic interest of the patient.
The same criterion of respect for the patient makes it necessary to restructure the hc, creating, on the one hand, a segment directly accessible to the patient, where the information obtained in the anamnesis and examinations and the factual considerations justifying the diagnosis and treatment have their place; and, on the other hand, a segment destined to reserved information, revealed by third parties or created by the physician with his personal and subjective assessments, or to certain clinical data that, occasionally, the mandate not to harm obliges him to reserve. The patient's right of access to his own hc - both to see it and to obtain a copy of it - makes it necessary to place this information in a separate file This means that the patient's control over his hc is not total, but admits certain limits. Genuine respect for the patient as a person will determine the restricted nature of this non-accessible information.
Conduct that seeks to obstruct or prevent the patient's knowledge the documentation relating to his or her state of health is not ethically justifiable. Professional secrecy cannot be invoked for this purpose, since it cannot be opposed to the patient who is the owner of the data. Nor can a dissuasive cost be imposed on the copy that the physician must submit to the patient.
The physician's ethical respect is universal, it does not admit any discrimination. For example, age. Minors, who are becoming active agents of their own freedom, are, to the extent that their ethical maturity allows, also masters of their own hc. The problem is complex. It is not easy to imagine that, in a healthy family in which parents respect their minor children, violent tensions could arise between parental authority and the autonomy of the minor. But it is not difficult to imagine conflict situations in families broken by the lack of respect, often reciprocal, between parents and minor children, when one of the latter demands that information about his or her health not be disclosed to his or her parents.
Finally, the fact that the hc belongs to the patient is sample in the tradition of transmitting to another colleague the hc or a copy of it, with the material elements of the diagnosis, as indicated in article 13.6 of our Code. The patient's freedom to change doctor or health center entitles him/her to ask the doctor who was treating him/her until then to transmit to the new doctor, without any delay that could be detrimental to his/her care, all useful and necessary information for the fill in or for the continuation of the treatment, as well as to facilitate the examination of the tests carried out.
Moreover, in France, for example, the power of the patient overrides the principle of the uniqueness of hc. Thus, although in group practices the patient's history file is considered a shared asset at the service of all the physicians in the group, the hc can only be used with the patient's authorization on the occasion of substitutions of one physician for another. The patient has the right to demand that his history be available only for a specific physician. If he/she is seen by a different physician, he/she will open a new record for the occasion.
The ethical arguments in favor of the patient as owner of his hc are very strong. So much so that in some countries it has been applied with an almost literal realism: the internship of the patient retaining the hc in his possession and taking it with him when he goes to see his different doctors has been tested with good results. And, according to some trials carried out in the United Kingdom, patients, especially women, know how to keep their clinical documentation better than the archivists in hospitals and clinics.
It belongs to the deontological tradition that the collection and essay of the initial medical history (event that motivates the enquiry with the physician, collection of the data of the staff and family anamnesis, physical examination, determination of the complementary examinations, establishing the diagnosis and proposing the treatment) are specifically medical functions, which require the professional skill and the ethical commitment that only medical Education confers and that cannot be delegated to a non-physician. The reason for this non-transferable character lies in the fact that the hc is not a simple descriptive enumeration of events and symptoms that the patient himself could compose, but is a record of specifically medical acts and judgments, of a diagnostic, preventive or therapeutic nature.
The hc is the doctor's because it relates the intellectual pathway he has followed in treating his patient. In it, the physician writes in the first person, describing his professional relationship with the patient. For this very reason, the hc belongs to the physician. It is not a hyperrealistic account of weaknesses of the human body or soul, but an objective and sensitive enumeration of symptoms and experiences, of exploratory data and advice, of decisions taken together, of acts that the doctor undertakes with the patient's authorization.
The ethical respect for the patient with which the physician writes his comments and records information from third parties should be such that the patient's access to the hc is no longer problematic. Nothing should be written in a hc - it has been said - that could not be published the next day in the local newspaper.
The hc belongs to the physician because it is like the notarial certificate of his ethical responsibility. His decisions, whether to act or to refrain from acting, must be explained in an intelligent and reasoned manner. The CC is compact, continuous, it hates gaps. The silences of the hc must appear not as negligent omissions, but as deliberate decisions. The physician, as the British physician has been strongly advised throughout his professional life, enjoys a great deal of clinical freedom, he can always do what he thinks best, but he must always be prepared to give a professionally acceptable explanation for his actions. This implies that, in his hc, which is his and not that of the computer technicians or the designers of forms and forms, he must state that his judgments, actions and advice are congruent with the state of the art at the time and with ethical-deontological standards. The hc belongs to the physician because what he writes in it is the attestation of his actions.
The fact that the hc belongs to the physician also means that it is the physician's responsibility to keep it in order. A recent survey among general practitioners revealed that, in France, 10% of them neglect the serious duty of opening the hc to all their new patients, however trivial this first visit may be. It also revealed that in almost half of the physician/patient encounters, no record is made in the hc, because the hc is not even consulted. It seems that these physicians rely on their report, with all the risks that this entails. The aforementioned survey also revealed that there are still doctors who think that a small cardboard card is enough to contain years of a patient's hc.
There are obviously complex situations regarding the singular or plural authorship of the hc. The Belgian Code of Ethics states, not without wisdom, that while the physician who alone has opened and completed the hc administers it at his convenience, when the hc is, on the contrary, the work of a team and centralized in a health establishment or in another institution, only the physicians who are called upon to provide services to the corresponding patients may have access to it.
The work of physicians in a group poses problems that are very difficult to solve. One of them is the difficulties that may arise when a physician decides to leave the group and wishes to take with him not only the hc of the patients who belong exclusively to him, but also those of the patients he has treated together with his colleagues. The destination of the hc should then be clearly defined in the group's constitution document, taking into account the possible wishes and interests of the patients.
There can be no hc without a medical owner. It is contrary to medical ethics for there to be unregulated hc's, without a known master, without a physician or medical team to control them. This can happen with the hc of very complex cases, seen by many physicians over a long period of time. But those cases are the ones that, curiously, tend to end up before the judge. These are hc's that accumulate unmanageable amounts of information: outdated laboratory data , clinical orders and follow-up notes with no day or time, time gaps that no one has filled. They are masterless stories that have not found someone to order them, to recapitulate them, to animate them with a spark of intelligence.
The Code of Medical Ethics and Deontology recognizes that, outside the patient-physician pair, there are many other characters who could answer "mine," if not to the question "whose is hc?" then to the very close question "whose is the use of and responsibility for hc?
According to some, society cannot aspire to the ethical possession of hc, for the simple reason that a free, democratic and civilized society cannot possess people or invade the deepest personal strata. According to this view, hc belong to that inner core of intimacy that cannot be possessed by third parties. It would be the patient and the physician who, given certain needs of efficiency and order, assign to different social entities the functions and services of administration, use and control of hc, and confer on them the corresponding powers and attributions. Even if these social entities were to have a great deal of power and responsibility, they would not become owners or co-owners of the hc, but rather highly qualified and authoritative administrators and advisors.
According to another ethical view, certain social organizations could enjoy the degree scroll of plenary session of the Executive Council right of the hc and claim for themselves a degree scroll of ownership over it. They argue that both patient and physician do not end their existence as mere individuals, isolated in an ideal limbo, but are also members of a social community and, above all, of a health community. This communitarian rootedness, essential to the concept of social medicine, makes hc cease to be a private document belonging exclusively to the patient/physician pair, to become in a certain sense something over which the social and health communities have strong rights.
In fact, in health centers and hospitals, hc need to be integrated into centralized archives: they must be accessible to many people who, at one time or another, want to have them at hand, their use and circulation must be controlled, and they must be used for specific purposes. These hc reside in a special habitat, where they are produced and carried daily by more than one physician. They need to be neatly guarded, protected from physical damage and accidental loss. And someone has to transfer them to another institution when the patient so determines; to the patient, someone has to give the hc or a copy of it whenever he or she decides to exercise his or her right of access.
I make no secret of my sympathy, despite the prevailing opinion to the contrary, for the theory that hc is co-owned by patient and physician, and that the social agents are not owners but highly skilled stewards. The degree scroll of ownership, from an ethical point of view, is not a matter of stationery, letterhead or footnotes. There is an ethical principle, forcefully manifested by the Declaration of Helsinki with respect to experimentation on human beings and which can be predicated here of the "social" uses of hc: that the interests of science or society can never prevail over those of the individual. Everything is settled, on the one hand, by a sharpening of the sensitivity of individuals to social needs and a growth in convictions of solidarity; and on the other hand, by a Withdrawal from the passion of the management assistant control everything and to demand a literal submission to the rules.
Whoever, physician or patient, refuses to authorize the use of their hc for well-founded clinical research, or to carry out quality assessments, clinical protocols, or collective or individual professional audits, would be demonstrating a perverted autonomy. The current Code of Medical Ethics and Deontology sample open to such uses of hc: in article 13.4, after stating that hc are written and kept for the patient's attendance , it adds that hc can be used for other purposes as long as they comply with the rules of medical confidentiality and are authorized by the physician and the patient. It adds in article 13.5 that, subject to the patients' right to privacy and confidentiality, their hc may be the object of scientific and statistical analysis, publication or presentation for teaching purposes. Further on, article 17.5, while giving ethical rules on the computer applications of medical data banks, authorizes the cooperation of the physician in audit programs of study (epidemiological, economic, management or of any other nature) on the express condition that the information used therein does not allow any particular patient to be identified either directly or indirectly.
These operations and functions, so varied and complex, require the cooperation of qualified technicians. It is precisely here that an act of delegation to third parties is configured, always linked to the commitment on the part of the latter to respect the ethical rules of the main actors. This ethical commitment integrates these collaborators into the moral community of the medical profession and they become, so to speak, part of the medical family. This creates an atmosphere of trust that allows and encourages the initiation of programs of study and research to promote or protect certain interests of society. The exercise of these responsibilities does not confer per se a degree scroll ownership, but rather an extensive functional authority, which implies a broad domain, close to that enjoyed by an owner manager, but not coincident with it.
It is necessary to introduce among all those who work in hospitals and outpatient clinics the idea that in the hc they do not deal with papers, but with people. There is, in our Code, a rule that sample the clear difference between things and people. article 17.2 prescribes that the computerization systems used in healthcare institutions shall maintain a strict separation between clinical documentation and the management assistant. It is a rule of prudence to separate these two major areas of the information handled in the hospital. It creates a great deal of freedom of action in the administrative field, frees the delicate clinical documentation from bureaucratic contaminants, avoids serious risks to medical confidentiality, and reveals a glaring truth: clinical documentation is not a reservation repository for the hospital's management management assistant .
A final remark. The inspiration and management of what we could call "social" uses of hcresearch, teaching, audits of different subject, quality control of the activity of persons and centers) require, given their medical nature, that they be performed by persons who, in addition to being clinical researchers, teachers, inspectors, audit experts, are usually registered physicians. In other words, they are subject to the principles, requirements and rules of the Code of Medical Ethics and Deontology governing interprofessional relations. When they audit or inspect, investigate or teach, they cannot forget the rules of fellowship: correctness, loyalty, deferential attention , respect, refraining from contemptuous criticism, the civilized resolution of disagreements, the obligation to denounce conduct that deserves ethical reproach in accordance with what is established.
Finally, I would like to offer a proposal for discussion. The hc has several ethical owners, who will have to coexist in something similar to a regime of shared property. An essential element of this coexistence is the recognition of personal rights, but also the acceptance of the solidarity-based nature of society. In the healthcare context, the rights of the physician, the patient and the institutions, and their corresponding responsibilities, must be combined with the search for the benefit of all and the increase in social welfare.
In the deontological tradition of continental Europe, there is a concentric order of priority among the owners of hc: patient, physician, healthcare institution, society in general. The patient, through his free and informed consent, can cede hc for multiple uses of social and scientific interest. The physician has strong moral duties, which, with the priority rights of the patients saved, urge him to favor the use of the hc created by him in scientific programs of study and in audits for different purposes.
This same tradition, human and supportive, places in third place the institutions that have to carry out, as delegates, not as owners, an essential and necessary work of custody and conservation.