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Abstract

Electronic patient records (EPRs) are electronic versions of traditional paper-based patient records (PBRs). They contain a patient’s medical history inclusive of diagnoses, medications, immunizations, family medical history, etc. as well as contact information. They may also contain radiological images and other diagnostic data not generally found in PBRs. Informatically, they function as patient analogues in decision space. Being electronic in nature, they can be transferred to data storage devices and be electronically transmitted, received, retrieved, searched, linked, or otherwise manipulated for various health-care-related purposes. They are increasingly replacing PBRs because they facilitate efﬁcient and cost-effective health-care delivery and planning and make possible e-Health and telemedicine – the practice of providing medical care to geographically distanced patients through electronic communication and information technologies. However, they also raise ethical concerns that center in privacy and conﬁdentiality, and the technical problems they encounter – integrity, security, and interoperability as well as updating legacy systems – present ethical problems in their own right. Issues such as ownership and secondary use for research also assume new dimensions, and the outsourcing of EPR-related services introduces legal complications that can undermine the standard ethics of patient records.

Introduction

Types Of EPRs

EPRs may have various formats depending on where they are kept, whether they have a special purpose and who has the right to access them. They also come in different types and go by different names. For instance, EPRs that are kept on hospitals and health networks are generally called electronic health records (EHRs). They contain detailed information that is relevant to patient care in the hospital setting. These records are accessible only to hospital staff and authorized hospital administrators and are security protected by passwords or similar measures. When properly constructed, they are logically layered in such a way that particular types of patient information are accessible only to authorized professionals on a need-to-know basis.

Electronic medical records (EMRs) are EPRs that are kept in physicians’ ofﬁces. They tend to contain only the kind of patient information that one would ﬁnd in traditional paper-based patient records in doctors’ ofﬁces, and while typically they give a better longitudinal picture of the patient’s health proﬁle than EHRs because they contain information about every doctor visit by the patient, they tend to contain less technical medical information than EMRs. As is the case with PBRs, the length of time that EMRs need be retained is generally subject to legal considerations that vary from jurisdiction to jurisdiction.

Personal health records (PHRs) contain the same types of information as EHRs and EMRs but are usually less formally structured because they are designed to be accessed by the patients themselves. They also are generally less detailed than EMRs or EHRs.

Historical Development Of EPRs

Patient-speciﬁc medical records are a relatively recent development in the history of medicine. They only began to be kept for health-care purposes in the latter part of the nineteenth century (Siegler 2010). Before then, if patient-relative medical records were kept at all, they were kept mainly for accounting and peripherally for teaching purposes. They were paper based, and it was only in the second half of the twentieth century, with the advent of electronic methods of recording and storing data, that EPRs were developed and began to replace PBRs.

Hospitals led the way in this regard because EPRs made communication between different hospital departments easier, more efﬁcient, and less subject to misinterpretation than PBRs where handwriting could sometimes be problematic. Administrative tasks such as planning and accounting were also made easier, and research, which depends on ready access to accurate patient data, was also facilitated.

The reason this development was initially limited to hospitals and large health-care institutions was that the cost of translating PBRs into EPRs can be considerable, and using them requires putting into place and maintaining a sophisticated and reliable electronic infrastructure. It also requires staff training, which can be expensive. For this reason, privately based physicians and small clinics have been slow to follow the trend and have not yet caught up to their deployment in the hospital and institutional setting (Miller and Sim 2004). However, a factor that contributes to their increasing acceptance is the prevalence of medical specialization, which makes it imperative that primary care physicians and medical specialists communicate with each other and have access to patient data from beyond their own patient encounter so as to be able to provide optimal patient care. EPRs make for easier, quicker, and cheaper communication in this regard.

The ease of communication and cost-effectiveness also make EPRs extremely useful in rural areas where referrals by primary care physicians to clinics and hospitals is an everyday occurrence and communication of patient data through PBRs is slow, cumbersome, and expensive. They also are an essential part of the evolving disciplines of telemedicine and eHealth – the practice of providing medical care to geographically distanced patients through electronic communication and information technologies. eHealth and telemedicine make health care available on a cost-effective basis for patients who would either have to do without or have to travel great distances to receive appropriate care (Tran et al. 2008).

Finally, ﬁnancial reasons beyond those already indicated play a further role in the increasing use of EPRs. Hospitals cannot afford to meet the ever-growing patient demand for sophisticated diagnostic services by having diagnostic specialists such as radiologists available on a round-the-clock basis. Increasingly, therefore, hospitals are resorting to outsourcing – the practice of sending patient data for evaluation and diagnosis to specialists who are geographically distanced from the hospital but can guarantee a short turnaround time (Royal College of Radiologists 2010). This would effectively be impossible without EPRs.

EPRs And Ethics

EPRs may be considered materially and informatically, and each raises a series of ethical issues.

The Ethics Of EPRs Considered Materially

Integrity And Security

Considered materially, the ethical issues associated with EPRs include such matters as integrity and security, conﬁdentiality and privacy, storage, accessibility, usability, and compatibility (Goodman et al. 2011). Integrity and security arise as materially based ethical issues because, being electronic in nature, EPRs are susceptible to changes in the data that are contained in them or to erasure due to technical malfunctions of the software that encodes them, the medium in which they are stored, or the communication technology through which they are transmitted and accessed – none of which affects PBRs. Therefore the ethical deployment of EPRs requires the establishment and maintenance of appropriate transmission technology and of error-free storage that is performance hardened so that EPRs are not altered or wiped by equipment malfunction. For similar reasons, backup functions are an essential aspect of the deployment of EPRs, and continued monitoring of the software performance is necessary to ensure that the data contained in EPRs are not altered or made technically unavailable. While these problems are technical in nature, they have ethical implications because unless they are adequately addressed, patient care that relies on EPRs cannot be delivered and health-care providers cannot meet their ﬁduciary obligations toward their patients.

Interoperability

Further, since EPRs can only be interrogated using electronic technology, their usability requires retrieval mechanisms capable of decoding into a usable format the electronic impulses of which they consist, which in turn means that the deployment of EPRs demands ensuring interoperability – technical compatibility between the relevant recording, storage, and retrieval devices – and the hiring of properly qualiﬁed staff to ensure their dependable operation.

It also requires interoperability between the software formats that are used to encode, transmit, and receive them. While in jurisdictions such as Europe, Canada, and the USA, some technical standards have been established in this regard, and while there is an international movement to generalize these – for instance, the International Organization for Standardization’s (ISO) Technical Committee (TC) on health informatics has developed standards regarding the compatibility and interoperability of independent systems to allow for the seamless transfer of clinical and administrative data between hospital information systems – there is no global agreement on these matters. In an increasingly mobile world, this makes the international use of EPRs still less useful than PBRs, where interoperability is not a problem. The closest problem that PBRs encounter is that of translation.

Legacy Systems

These materially based ethical issues acquire a novel twist from the fact that the technology used to generate and store EPRs evolves and matures over time and that the electronic formats and platforms change as well. This is sometimes referred to as the problem of legacy systems (Bisbal et al. 1999). Unless appropriate measures are instituted to update not only the material technology but also to translate the electronic formats and platforms of EPRs to keep pace with ongoing changes, older EPRs will become unreadable and hence useless. Health-care institutions and providers therefore have an ethical duty to ensure that this issue is appropriately addressed when they switch to EPRs since otherwise their ability to fulﬁll their ﬁduciary duty toward their patients will be impaired.

Privacy And Confidentiality

Privacy is the right of individuals to control information about themselves; conﬁdentiality is the corresponding duty to protect the privacy of individuals. Both have material and informatics components. Materially, the issue is how to ensure that the tools, devices, programs, or methods used to establish, store, transmit, access, or manipulate EPRs provide maximal protection.

The right of privacy and the duty of conﬁdentiality in health care go back as far as Hippocrates and are integral to modern health care. Not surprisingly, therefore, most countries – as of 2015 China, Egypt, India, Malaysia, Pakistan, Thailand, and Turkey constitute notable exceptions – have speciﬁc laws dealing with the privacy and conﬁdentiality of medical records. Originally, these laws were developed relative to PBRs; however, the basic principles apply to EPRs as well since the underlying issue is the same.

While material privacy and conﬁdentiality are relatively easy to ensure when EPRs are stored in physically isolated systems located in the place where patient care is provided, it can become problematic when EPRs are cloud stored (Chen et al. 2012), which is to say when they are stored – either distributedly or as single records – in servers that are geographically distinct from where patient care is provided since this increases the opportunity for outside interference in the communication process and multiplies possible attack points on the records themselves. For these reasons, it is generally agreed that there lies an ethical duty to use encryption whenever possible so that even if an unauthorized electronic intrusion were to occur, privacy would not be compromised (Alanazi et al. 2015). It is also agreed that decoding parameters should be matched to need-to-know and that failure to institute such measures constitutes an ethical default.

This assumes still different ethical dimensions when EPR services are outsourced to providers who are incorporated in or whose servers are located in jurisdictions other than those of the patients or health-care providers since privacy laws may differ. This can become especially problematic when service providers are located in countries that have legal requirements to provide back doors for government security services into the systems or to permit access without notifying the patients whose EPRs are accessed and where these requirements differ from the countries where the patients are located. An example of this is the case of informatics service providers who are incorporated in the USA and whose servers fall under US jurisdiction. In such cases, privacy as it is usually understood cannot be assured.

The Ethics Of EPRs Considered Informatically

When EPRs are considered informatically, analogous ethical issues arise. Informatically, EPRs are sets of health data that are linked to speciﬁc patients. In information-theoretical terms, EPRs are patient-relative n-dimensional data spaces (n being the number of different types of data contained in the record) that function as the informatics and epistemic foundations of the speciﬁc patient proﬁles, diagnoses, and treatment options that are developed by the health-care professionals – usually physicians – who access and use the EPRs. Among others, the ethical issues that arise on this basis include privacy, ownership, disposition, security, and accessibility. Although these are similar to those that arise when EPRs are considered materially, they acquire distinct dimensions because EPRs function informatically as patient analogues in information and decision space (Kluge 2008).

EPRs As Patient Analogue

EPRs and PBRs differ in this regard, and the reason lies in the way data enter the types of records. Data enter PBRs as merely material entities – as marks on paper. Their meaning and logical forms – i.e., the possibilities of combination of the data for which the marks stand – and hence the data spaces in which they are embedded depend on the professionals who access the records and who, by seeing them as having a certain signiﬁcance, epistemically contribute the logical forms that turn the marks into meaningful data and make them combinable into information. Therefore the data spaces that can be associated with PBRs are not integral to the records themselves and are not independent of the external observer.

By contrast, data enter EPRs not simply as electronic impulses to which the observer must contribute a logical form by seeing them as data points with certain possibilities of combination (and hence as having a certain informational signiﬁcance). Instead, in order for something to enter as a data point at all – in order for something to be able to be a component of an EPR – it must enter as something that is embedded in (and therefore is logically deﬁned by) a matrix of logically possible combinations. Unless something has this logical structure, it cannot enter the EPR. In information theoretical terms, unless data points come embedded in a matrix of possibilities of combination, they will not be data but “noise.” Therefore, because the logical matrix of possibilities of combination is integral to the nature of anything that enters an EPR, it automatically gives rise to a data space whose nature is determined by the logical forms of the data – which in turn depends on the qualitative nature or value of the data themselves. This means that EPRs themselves informatically consist of a series of data spaces that can be analyzed from various points of view, resulting in different kinds of patient proﬁles, depending on which data points are selected.

In that sense, EPRs are much like the patients from whom the data that make up the EPRs are derived. Informatically speaking, patients materially present with a totality of qualities or characteristics each of which is embedded in a set of possible relations to the other qualities or characteristics with which the patient presents. One and the same patient will be viewed differently by different health-care specialists who focus on different aspects of these characteristics. Podiatrists focus on one set, hematologists on another, dermatologists on still another, etc., and they construct distinct (but often overlapping) patient proﬁles of one and the same material patient. Therefore, while the material patient is independent of observation, the patient proﬁles that are developed by health-care professionals are functionally dependent on the professional.

With due alteration of detail, the same holds true for EPRs. Considered in themselves, the data in an EPR that are the result of X-ray scans of a particular piece of bone are embedded in a set of possible relations with other data, where the logic of these possibilities mirrors the logic of the bone’s properties such as density, composition, size, etc. Similarly, the data that result from an immunological assay of a given serum sample capture certain logically distinguishable aspects of the serum sample and allow them to be related to each other with respect to type, concentration, agglutination factors, and so forth. Each datum, therefore, can be understood as having both a value that gives its content and a logical form that deﬁnes its nature and that allows it to be related to other data. In this way, the data that make up an EPR logically give rise to an n-dimensional matrix of possibilities of combination, n being the number of different types of data contained in the record. It is in this sense that EPRs are informatics analogues of the patients who are the subjects of the EPRs. And just as the patient who is the subject of the record can be approached from the different perspectives, so the EPR can be approached by focusing on different data as relevant and by correlating them into distinct systematic wholes. Not every medical specialty will consider the same set of data as relevant or important, and not every health-care professional even within the same specialty will focus on the same set of data. It depends on professional experience and preference. In each case, however, the result of selecting and correlating a particular set of data constitutes a patient proﬁle (Kluge 2001; Gupta 2008).

Ownership

This raises the issue of ownership. Who owns the EPR as such, and who owns the patient proﬁle? In each case, the answer is twofold. The material entity that is the EPR – the instrument or item in which the record is stored or otherwise kept – is owned by the individual physician, institution, or corporation who keeps and maintains it; however, the data and proﬁle in the EPR are owned by the patient whose record it is.

The reason is twofold. First, as a function of the patient’s right of privacy, the informational relationship between the data and the patient gives the patient dispositionary power over any patient-unique data. That is why it is generally recognized that patient records inclusive of EPRs may not be established, accessed, used, stored, transmitted, or otherwise manipulated without permission of the patient (or of a duly empowered substitute decision maker). The issue becomes somewhat unclear in the case of genetic data. An emerging opinion is that while the unique genetic proﬁle of an individual patient is owned by that patient, this may not be true about speciﬁc genetic data that are contained in the EPR if the patient is a member of a genetically identiﬁable collectivity and the material (genetic) basis of the data is shared by members of the collectivity. While this has been tested in very few cases and mainly in the context of gene patenting, the underlying ethical claim here is that because the genetic basis is shared, the collectivity is the owner of the data and has dispositionary power over them.

Second, it is standardly recognized that unless explicitly agreed otherwise, someone who provides a service does not own the product of that service. This means that while the algorithms, methods, or devices that are used by a physician or health-care professional to develop a particular patient proﬁle belong to the professional – they are analogous to the tools that are used by workers when they engage in their trade – the proﬁles themselves, being the products of a service, belong to the patient.

While the ethics of EPR ownership is fairly clearly, legally there is no uniformity on the matter; it all depends on the jurisdiction. For instance, in the USA, data contained in an EPR belong to the patient (Brodnik et al. 2009), as is the case in Europe. In India, however, patient records are owned by the physician or institution, and in Japan, the issue has not been conclusively resolved and is in a state of ﬂux. In many other jurisdictions, the issue has not been speciﬁcally addressed and privacy considerations tend to dominate.

Another issue that has not yet been explicitly addressed in most jurisdictions is who owns the EPR of deceased patients. Ethics would suggest that they should be treated the same way as PBRs, but the matter still awaits formal resolution. The matter is of some importance since EPRs are eminently searchable and therefore an invaluable resource for epidemiological research both on a national and an international level. Privacy rights are also implicated in this regard, since the two are correlative and overlap to a considerable degree.

Privacy And Confidentiality

Although data ownership and privacy rights are related and overlap, logically and ethically they are distinct. Ownership involves a bundle of rights that include the right to transfer what is owned to another, who is then the owner of the thing in question. Privacy is the right of control over information that is speciﬁc to and identiﬁable of oneself as person. Privacy is grounded in and ineluctably tied to the individual, and while control of privacy may be relaxed or even transferred to another, the right itself cannot be transferred.

It has been part of medical ethics since Hippocrates that patient information is protected by a sphere of privacy that, all other things being equal, may not be breached except with permission of the patient and that physicians as well as those otherwise in physical possession of the patient record – and this includes those who provide a cloud-based storage and retrieval service – have a duty of conﬁdentiality. Ethically this means that access to EPRs should be limited to authorized parties.

Authorized parties primarily include the professionals who provide direct patient care but also those who have an otherwise legitimate need-to-know. Need-to-know is here the determining factor. However, it is not a foregone conclusion that health-care professionals who provide patient care automatically have an ethical right of access to the whole EPR simply because they provide patient care. What patient data are relevant to the care that professionals provide depends in their role and the needs of the patient. Going beyond this without patient permission constitutes a violation of the patient’s right of privacy. Informatically speaking, therefore, and from an ethical perspective, EPRs should be logically structured to allow division into distinct data domains, and access privileges should be matched to need-to-know and should prevent access to data that have nothing to do with the role of the professional. Ethically, therefore, access to EPRs should not be an all-or-nothing affair (Kluge 2001).

At the same time, unforeseen circumstance and emergency contexts may require that health-care professionals go beyond the data domain that normally is the characteristic of their area of service or expertise. In such situations, the otherwise appropriate privacy limits need to be breached to allow the processionals to fulﬁll their ﬁduciary obligation of providing appropriate patient care.

Consequently EPRs ethically require override functions that may be engaged on such occasions – with the proviso that any such override be recorded, traceable, and non-repudiable so that it can be justiﬁed and the overall ethics of privacy maintained.

Research

The data contained in EPRs can easily be sorted relative to a particular enquiry. For that reason, EPRs are ideally suited to health-care-related research. In some jurisdictions, research-related access to EPRs is permitted without patient consent, and patient privacy is not considered to be compromised as long as the researchers are accredited and are using a formal research protocol that has been approved by a duly constituted research ethics committee, where researchers have both an ethical duty and a legal duty not to divulge identiﬁable patient data without patient consent. On occasion, this can be further strengthened by electronically removing identiﬁers that can link the data to a particular patient without compromising access to or the validity of the data themselves.

Searchability makes EPRs particularly attractive for epidemiological and post-marketing surveillance studies. The focus of these, respectively, is identifying health-related risk factors for diseases and conditions, trends, and patterns in the spread of diseases and target populations of particular concern or gathering longitudinal evidence on the efﬁcacy or effects of pharmaceuticals and health-care interventions as these are deployed in actual practice. Such studies are invaluable for developing public health policies and making evidence-based health-care allocation decisions. They are also necessary for determining whether drugs or medical interventions developed in formal clinical trials, and on which pharmaceutical licensing and practice guidelines are based, are consistent with what happens when these are used on uncontrolled populations. They are therefore integral to discharging the ﬁduciary obligations that health-care providers have toward the patient populations whom they serve. When properly employed, the anonymization and de-identiﬁcation feature of EPRs provide a relatively easy and cost-effective way of meeting the privacy concerns that arise in this connection and that otherwise would require potentially cumbersome methodologies that would interfere with or detract from the ability to develop such information in a timely and efﬁcient manner.

EPRs, eHealth, And Telemedicine

The Physician-Patient Relationship

The ethical implications of EPRs are extended when they are viewed in the context of the evolving disciplines of eHealth and telemedicine – the application of electronic information and communication technologies to the geographically distanced delivery of health care. In health care as it is traditionally structured, the direct personal encounter between physician and patient marks the inception of a ﬁduciary relationship which demands that the physician always act in the best interest of the patient. On this model of health care, therefore, the inception of the ﬁduciary physician-patient relationship does not depend on any kind of record. While records facilitate the fulﬁllment of the physician’s duties and are integral to providing quality care, they are not causal factors in the inception of the relationship itself.

By contrast, the use of EPRs cannot be dispensed with in eHealth and telemedicine and the direct physician-patient contact that normally grounds the inception of the physician-patient relationship does not exist. Aside from viva voce interactions, it is only through EPRs that there is any contact between physician and patient. EPRs are here instrumental in establishing the physician-patient relationship itself, and accessing the EPRs marks its inception.

This is fundamentally different from traditional health care even when medical consultation enters the picture – for instance, when a primary care physician requests the evaluation of a specialized medical test from a consult or asks a specialist for the diagnosis of a particular condition on the basis of transmitted X-rays, ultrasounds, MRIs, etc. While this involves the transfer of patient records, it does not establish a ﬁduciary relationship between the consulting physician and the patient.

In the absence of direct contact between the patient and the consulting physician – which only occurs when the patient is referred to a specialist and actually goes and sees that specialist and which then sets up a ﬁduciary physician patient relationship in its own right – any duty that the consulting physician might have holds only between the consulting physician and the primary care physician. It is contractual in nature, and any problem that arises in this connection is properly analyzed in terms of professional negligence. If one can talk about a ﬁduciary relationship in this context at all, it is secondary in nature and is derivative of the relationship between the patient and the primary care physician – which in turn relies on direct personal contact. For that reason, EPRs have fundamentally altered the ethical fabric of modern and electronically extended health-care delivery and in this respect are ethically unique in the history of health care.

EPRs And Outsourcing

Acute health-care delivery is expensive, particularly if such care is to be provided on a round-the-clock basis, since it requires the availability of relevant specialists. For this reason, many modern hospitals have turned to outsourcing – to sending the relevant technical medical data for assessment, evaluation, or manipulation to someone outside of the hospital and who can provide round-the-clock services on a cheaper basis. This means that a radiologist may be in Bangalore, while the contracting hospital may be in Maine or Leeds and data input may occur in Helsinki or Cape Town, while the assessing professional may be in Chennai, Hong Kong, or West Virginia (Kutscher 2012). However, these different jurisdictions have different legal and professional views on the status of medical records in general and EPRs in particular. Unless there is a consistent understanding of the nature of EPRs, the treatment of EPRs will be subject to the vagaries of treaty negotiations, national laws, and professional perspectives.

This becomes particularly difﬁcult when even the minimal international ethical standards that exist – such as Article 12 of the Universal Declaration of Human Rights – are subordinated to the pragmatic interests of individual nation states. An example is provided by the USA PATRIOT Act. This Act, whose full title is Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act, allows US intelligence agencies (and through reciprocal agreements afﬁliated intelligence agencies all over the world) to access the EPRs in the possession or under the control of US informatics professionals, corporations, or institutions without the subject’s consent or knowledge just as long as the agency believes that the subject of the EPR is in any way connected with their own intelligence mandate and makes it a criminal offense to inform the subject of the EPR that such an invasion of privacy has occurred. Given the ever-increasing security concerns of many nation states, EPRs more and more become targets of interest because they provide information that may be useful in the structuring interrogation techniques of security forces to elicit security-related information (Hickman 2013; Miles 2007). This raises ethical concerns that focus in privacy, conﬁdentiality, and security of the person.

Conclusion

EPRs have the potential of greatly improving the quality and range of patient care that can be delivered on a cost-effective basis at the hands-on and the institutional level. They are pragmatically useful not only in improving hands-on health care and facilitating communication between specialists, but they also make eHealth and telemedicine possible, thereby extending the ability of healthcare providers to fulﬁll their ethical mandate of providing appropriate health care to those who would otherwise go without or be underserved. Because they are easily searchable, they can be valuable tools in health-care-related research and for developing appropriately structured healthcare policies. Finally, they make it possible for patients to have access to their own records in a meaningful way – something that is almost prohibitively cumbersome with PBRs.

However their use raises ethical issues that are not encountered with PBRs – the issue of legacy systems, for instance, and the issue of interoperability – and it assumes new proportions regarding traditional ethical issues such as privacy and conﬁdentiality. At present there are no international certiﬁcation standards or guidelines for the records themselves or for the professionals who deploy them, and whatever legal measures exist are jurisdiction dependent and lack global enforcement mechanisms. In an increasingly mobile world where outsourcing and medical tourism are on the upswing, this raises ethical concerns.

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