Introduction
Modern health care in all its forms, whether at the administrative or operations levels,
increasingly relies on the development, implementation, and use of health care information
systems and clinical data exchange between electronic health records (EHRs) over organisational
and geographical jurisdictions. Increasingly, these complex socio-technical information
systems are being outsourced to commercial service providers and use software as a
service (SaaS) solutions, networked by the Cloud. The need to share sensitive health
care information across jurisdictional borders brings with it challenging security,
privacy, and ethical issues[1].
Security standards adopted by international organisations such as the Organisation
for Economic Co-operation and Development (OECD) and the International Organisation
for Standardisation (ISO) are widely used in the design and development of health
care information systems. Privacy by Design is a model adopted by the privacy community
as a process for software developers to design, develop, and implement information
systems where privacy is the default[2]
[3]
[4].
While security standards and privacy practices may have a general ethical basis, they
are typically focused on the technical development of systems and the management of
data. What has been missing until recently in the development and management of health
care information systems is an ethical code for health informatics professionals (HIPs)
who are responsible for the governance, management, procurement, and security of health
care information systems.
In 2015, the Security in Health Information Systems (SiHIS) working group of the International
Medical Informatics Association (IMIA) initiated a long-term project, the Global Protection
of Personal Health Data, to identify the requirements for protecting personal health
information within an international context. The working group held workshops and
collaborated with others in the field to identify appropriate security, privacy, and
ethical measures for rectifying current issues.
The recently revised IMIA Code of Ethics for Health Information Professionals[5], that is based on the Universal Declaration of Human Rights (UDHR), has found general
acceptance in the international community of informatics professionals. The UDHR,
proclaimed internationally in 1948, explicitly mentions and indeed is based on several
fundamental ethical principles that are recognized as binding on all persons, governments,
and agencies irrespective of differences in socio-cultural or legal frameworks[6]. The IMIA Code encompasses these fundamental principles and provides a set of derivative
principles and rules that are specific to health informaticians. The authors suggest
that these can serve as the basis for a globally valid ethics-based certification
programme for HIPs.
The term certification has many meanings. Certification can be a formal procedure or it can refer to the
confirmation of certain characteristics of an object or entity. In this paper, the
latter definition is used. For example, Certification of HIPs would indicate that
a health informatics professional would know, understand, and apply ethical principles
in the governance, management, and operations of health care information systems and
EHRs.
It is important to note that other professional organisations have also adopted ethical
codes, standards, and guidelines for the development of health care information systems,
software engineering, implementation and management of these systems, and the contents
of the EHR. Organisations include, among others, the Association for Computing Machinery
(ACM), Institute of Electrical and Electronics Engineers (IEEE), Health Information
and Management Systems Society (HIMSS), and the American Health Information Management
Association (AHIMA).
Compared to these previous codes of ethics and guidelines, this paper presents a unique
viewpoint that is focused on the iduciary relationship that exists between HIPs, health
care professionals, and the subject of care (the patient), and how HIPs act ethically
in this relationship.
Method
As a preamble to its constructive work, the authors conducted a review of privacy
principles and security standards in order to determine what had and what had not
been done, and in what sense ethical considerations had been integrated into the various
undertakings. The authors found that privacy and security was the subject of considerable
attention, relative to the recent General Data Protection Regulations of the European
Union (GDPR)[7], but most importantly it appeared that trustworthiness figured largely as an underlying
theme in a series of official and regulatory pronouncements. The authors also found
attempts to place trustworthiness in a measurable footing using system modelling methods,
system analysis, and system engineering techniques[8].
The authors also evaluated privacy, security, and trust approaches with respect to
their ethical soundness and interjuris-dictional usability in light of the existing
differences in professional and legal standards. Based on these findings the authors
developed a proposal for an international ethics-based HIP certification programme.
Results
Existing Guidelines and Codes of Conduct
The authors found that while the majority of guidelines and ethical codes essentially
focused on the role and functioning of the institutions that use EHRs, information
technologies themselves, and on what had been developed to maintain system security
and functionality, there was also recognition that these codes should extend to HIPs
who actualize and operate the systems. The authors therefore investigated what measures
of qualification had been developed for HIPs, and also what Certification and education
programmes had been developed for them[9]
[10]
[11]
[12]
[13]
[14]. These findings were further subjected to a similar analysis relative to their ethical
tenability, situational appropriateness, and interjurisdictional validity.
In the main, the authors found that at the institutional, corporate, and vendor levels
the focus of ethical codes and guidelines were centred in security, confidentiality,
usability, and technology as well as in the ability to respond quickly to specific
needs as these arise in the various contexts. It also became apparent that existing
ethical codes and guidelines were neither integrated nor mutually consistent, and
there was no attempt made by the institutions, corporations, or vendors to validate
their ethical acceptability.
As to codes of conduct for HIPs, it was found that they tended to conflate ethical
and legal considerations. Actually, there were some exceptions. For instance, the
American Medical Informatics Association has developed a code of conduct for its members
and has even promulgated guidelines for the secondary use and re-use of health care
data[15]
[16]
[17]. The British Computing Society has also developed a code of conduct[18], as had the Australasian College of Health Informatics[19]. Another example came from Canada, where Digital Health Canada has promulgated a
set of core competencies[20] which, to some degree, contained ethical considerations.
However, the primary focus of all such codes, documents, and provisions was not global
in health care system orientation, and was only focused on eHealth, telemedicine and
related modalities. As well, the codes and other provisions were not integrated with
other ethical codes and guidelines that should be adhered to by health care organisations.
The application of these codes and provisions tended to focus on considerations that
were relevant to the respective jurisdictions in which they were developed, and hence
they were of limited use in the international setting. It appeared that there was
no evaluation of ethical proficiency, and the authors found that current HIP certification
programmes were not global in scope.
HIP Certification Programme
The purpose of certification is to ensure appropriate ethical knowledge is adhered
to by HIPs and the health care organisations in which they operate. As the IMIA Code
of Ethics indicates, the ethics of health informatics deals with the actions of HIPs
who are involved in the collection, use, security, appropriate disclosure, retention,
and disposition of data in the domain of health care. This means that being certified
in health information ethics testifies that whoever is thus certified is familiar
with and proficient in the ethical aspects of several distinct areas. These include
specific topics in health information ethics with which candidates should be familiar
as well as what might be called the vector space of the rights and duties that are
involved in these areas. These are outlined in the IMIA Code of Ethics.
The Certification process should be applied to include all HIPs that are working in
health care organisations, whether public and private. Certification would not only
establish their ethical proficiency as professionals but would also be consistent
with the general tenor of the European GDPR and related provisions.
The most effective format for measuring Certification proficiency for HIPs would be
by means of a standardized test. The test would rely on scenarios that involve the
issues in which proficiency is sought and would consist in having candidates correctly
identify the ethical issues involved, the parties who are affected, determine whether
the issues have been handled ethically appropriately, and have the candidates suggest
what should have been done if they have not been handled correctly. The particular
areas and subjects presented in these scenarios would follow the headings that are
identified as ethically important in the IMIA Code of Ethics. The scenarios would
illustrate multiple issues as these occur in real life, and the answer sections would
consist of a mix of true-false and multiple-choice options. The scenarios would be
based on actual cases that have proved problematic, where of course care would be
taken to alter identifying details so that the privacy of the relevant parties would
be protected.
The test itself would be in the nature of a secure on-line interactive web page, and
there would be a time limit for completing the task. This format would allow candidates
to access reference materials when answering the questions. However, rather than being
a shortcoming, this would be in keeping with real life. An ethically sensitive and
trained individual could, when in doubt, consult relevant and appropriate reference
material.
The Certification could be handled and administered by a specified international organisation
with ethics expertise to function as authority. For instance, IMIA in cooperation
with an appropriate body of the World Health Organisation (WHO) has the requisite
expertise and could function as a certifier. This option would have the advantage
of drawing on international professional health informatics expertise as well as the
health-related expertise of the WHO in the context of current eHealth and telemedicine
developments, and would ensure that industrial and commercial interests would not
supersede ethical considerations.
Unquestionably, there would be costs associated with developing, implementing, and
administering the Certification programme. It is important to present Certification
itself as not being subject to proprietary and fiscal interests that might influence
the quality or neutrality of the process itself.
The very nature of ethical certification is to ensure that appropriate ethical knowledge
and understanding is adhered to by HIPs and the organisations in which they work,
and that the ethical treatment of EHRs that underlies the reason for certification
in the first instance is not subject to non-ethical considerations.
Discussion
The Universal Declaration of Human Rights and the IMIA Code of Ethics for Health Information
Professionals form the basis of an ethics-based Certification programme for HIPs proposed
by the authors. The aim of the certification solution proposed here is to ensure that
appropriate ethical knowledge and understanding is adhered to by HIPs. To engage in
professional and technical activities without having the appropriate ethical competence
amounts to a violation of the Principle of Fidelity and constitutes malfeasance of
duty[21]. Technical proficiency is no guarantee that anyone would use the knowledge, products,
or services that are at his/her disposal in an ethically appropriate manner. If it
were otherwise, for example if the technical competence were all that was necessary
for proper professional activity, there would be no need for ethical standards and
codes of ethics, and there would never be any need for professional disciplinary procedures.
Ethical proficiency, therefore, should be integral to professionalism, and the proposed
certification solution is intended to certify such proficiency in a measurable sense.
From the other side, it is evident that knowing ethics rules is not enough. HIPs have
also to behave ethically in real life situations. While it is technically possible
to monitor behaviours of HIPs, this is not generally accepted and can be a violation
of privacy rights. To act ethically inside of a health care organisation, there should
be minimal to no conlicts between the organisational ethics and the ethical code of
a certified HIP. Despite the availability of general ethics university courses and
training programs, the authors suggest that the role of a HIP in a health care setting
is so unique that a health care related ethics-based certification is needed. A meaningful
challenge is that in many countries the professional designation of HIPs does not
exist. As health information systems are outsourced, it may be difficult to determine
which persons would require the proposed Certification.
A big question is how effective the proposed HIP Certification would remedy the issues
with hardware and software used in health information systems, namely the trustworthiness
of the system and EHR. If an ethical lense is applied to the design, development,
implementation, governance, and ongoing maintenance of a health information system,
would accountability in the use and disclosure of health care information in the EHR
improve the overall usability and security of the system ? The authors believe that
the ethics certification of HIPs is a realistic step, with further extension of a
vision that can only be true with large scale international regulators and multi-faceted
cooperation. A less desirable outcome is the eroding trustworthiness of health information
systems by the health care public where a digital system that purports beneficial
outcomes lacks ethical oversight, and breaches of sensitive health information become
the new normal.
The desirability of national Certification for HIPs in technical matters appears to
be well established and, as was already indicated, various national health information
organisations either have developed or are in the process of developing certification
programmes that would meet the technical standards set out by the ISO/TC 215 Health
Informatics[22]. At the same time, the development of ethically-based Certification provisions at
a national level would not address the issue of interjurisdictional ethical validity.
This may present logical and conceptual difficulties when trying to develop globally
defensible rules for ethical Certification.
To illustrate this point, a significant proportion of ethically unfortunate (or questionable)
events that involve EHRs in outsourcing is due to a lack of clarity of what the relevant
standards are and how they should be applied when national boundaries are crossed.
Thus, it is currently unclear how the ethical codes and/or principles that prevail
in one jurisdiction should be applied. Even more importantly, what fundamental principles
should be used when health information services are outsourced from one jurisdiction
to another[23]. For example, it is unclear what standards, ethics, or principles should apply when
radiographs originating from Chicago are read in Bangalore or Zurich, when health
service related billings originating from Berlin or Mexico City are outsourced to
Bloomington, Indiana, or Chennai[24]
[25]
[26]
[27]
[28], or when medical notes that have been taken in one country are outsourced for transcription
in EHRs to other countries where not only professional standards are different but
even the native language of the transcribing individuals is other than that of the
note-taking medical professionals[29]. What ethical considerations, if any, are relevant, and in what sense ?
At first glance, this state of affairs presents insurmountable practical difficulties.
Arguably, it would be impossible to establish a HIP ethics certification programme
in general that has global validity unless it was possible to identify ethical principles
that are recognized as being universally valid. More particularly, it would seem impossible
to develop an informatics ethics Certification programme unless there was a generally
accepted set of ethical principles and rules specific to health informatics that could
form its basis. This step has already been taken with the development of the IMIA
Code of Ethics for Health Information Professionals. What remains to be done is to
use this Code as a foundation and, with the effective involvement of relevant global
bodies such as the WHO and IMIA, to develop a Certification programme that has international
validity.
