Under international law, the enjoyment of the highest attainable standard of health is a fundamental right for every human being . In this context, such a right is understood as a standard of living that is adequate for the health and wellbeing of every person and all family members . Constituting an acknowledged right  as well as a fundamental human right [4, 5], the highest attainable standard of physical and mental health includes four basic elements: healthcare facilities and programs that (a) are adequate; (b) are equally accessible; (c) correspond with medical ethics, are sensitive towards specific communities, genders, confidentiality, and aim at improving the health status of those people concerned; and (d) are suitable for their predefined purpose, and as such are delivered together with a high level of medical and scientific quality . It follows that the right to health must be understood as a right to the enjoyment of a variety of facilities, goods, services and conditions which are necessary for the realization of the highest attainable standard of health.
The term Accreditation relates to the process in which an external body performs an evaluation of an organization or service using a set of standards for measuring process and performance [7,8,9]. Per ISQua, the International Society for Quality in Healthcare, its definition includes the following keypoints: a) it is a form of external evaluation of an organization, system or programme; b) the performance of the organization, system or programme is assessed against pre-determined requirements; c) the pre-determined requirements are generally set out in standards; d) the pre-determined requirements provide a service wide approach to quality improvement focusing on both operational and clinical aspects of service provision; e) the standards may address more than legal requirement; f) assessment is undertaken by a team of reviewers from an external, independent, third party who have specific knowledge and experience of the organization, system or programme being assessed; g) the aim of accreditation is continuous quality improvement; h) a report is generated summarizing the findings from the survey, identifying areas of good practice, and providing recommendations and opportunities for improvement; i) the output of accreditation is accreditation status, namely whether it has been granted or not and the level of accreditation which has been granted; and j) accreditation status is valid for a specific and defined period ). Accreditation processes have been introduced into organizations and sectors around the world, including higher education institutions [11, 12], industrial fields , voluntary organizations , and health sectors . The common objective of the process is to improve the quality indicators of organizations and sectors and to provide a basis for comparison – with other organizations in the same sector or among divisions and departments within the same organization .
Accreditation was traditionally a tool of voluntary regulation , conducted by independent providers upon the request of an interested organization. As a voluntary form of regulation, accreditation offers the following advantages: minimal-to-zero use of public funds and resources, increased efficiency and diminished bureaucracy, cooperation, and increased responsiveness. When carried out by an external provider, the process is often more transparent and less susceptible to political or other influences. Despite accreditation of healthcare services becoming mandatory in many parts of the world, especially the U.S. and Canada, the above listed advantages of voluntary regulation are still relevant in other fields or in countries where accreditation is yet to be obligatory.
While this type of regulatory regime offers several benefits, possible drawbacks may also be associated with the process. For example, in voluntary accreditation, available sanctions are limited and often difficult to enforce in civil or criminal law. Moreover, costs must be covered by the accredited organization which, in cases such as public hospitals, often lack sufficient resources to begin with. Another concern is that the applied standards may not necessarily fall in line with the mandatory guidelines and legislation such as those of the health system [15, 16].
In more than 100 countries including Israel, healthcare services are currently undergoing accreditation processes. In the context of healthcare, accreditation refers to an evaluation process carried out by an external body that examines the quality of healthcare services that are offered by healthcare organizations – usually hospitals – through standardized Quality indices [7,8,9, 17]. From a global perspective, up until the 1980s, this was a voluntary process designed to evaluate and adjust existing procedures and protocols to meet desired medical standards [9, 18].
Nowadays, accreditation bodies are working to create standards aimed at constantly improving the quality and safety of treatment as well as the overall management and operations of the accredited facility [19, 20]. It is believed that accreditation is a useful tool for improving healthcare service quality and safety . Generally, studies worldwide note a positive effect of accreditation processes on improving aspects of management and care, such as therapeutic outcomes among patients, interactions between teams and professions, risk management, resource management, as well as internal and external standardization of care, quality and safety in treatment [17, 21,22,23,24,25,26,27].
Accreditation programs frequently include a chapter on the protection and promotion of patients’ rights within the healthcare organization. At times, this is regarded as part of a larger effort for assessing its performance and its organizational and ethical climate . This is unique due to the central role of the patient and the potential impact of health on human rights . In addition, paying attention to patients’ rights and the organizational ethics of healthcare institutions are important issues in healthcare quality . Accreditation that addresses patients’ rights may also provide policymakers and patient advocacy groups with an effective instrument for informing medical practitioners, patients, and their families about such rights, and promoting and applying them within the healthcare system .
A range of accreditation providers offer services for healthcare organizations, the most notable ones being Accreditation Canada, the Australian Council for Healthcare Standards (ACHS) and the Joint Commission International (JCI). In the United States (USA), the Joint Commission is the primary provider of accreditation services to the healthcare sector. Since its establishment in 1951, the organization has evaluated tens of thousands of healthcare organizations and programs throughout the USA. The JCI is active in more than 40 countries, including Israel .
The declared goal of JCI is to improve the quality and safety of care provided by healthcare organizations around the world, through training, counseling, and service. JCI has created and implemented a set of valid standards to apply in organizations that are undergoing an accreditation process, including Patient-Centered Standards, International Patient Safety Goals (IPSG), Access to Care and Continuity of Care (ACC), Patient and Family Rights (PFR), Assessment of Patients (AOP), Care of Patients (COP), Anesthesia and Surgical Care (ASC), Medication Management and Use (MMU), Patient and Family Education (PFE), Healthcare Organization Management Standards – Quality Improvement and Patient Safety (QPS), Prevention and Control of Infections (PCI), Governance, Leadership, and Direction (GLD), Facility Management and Safety (FMS), Staff Qualifications and Education (SQE), Management of Information (MOI)), Academic Medical Center Hospital Standards – Medical Professional Education (MPE), and Human Subjects Research Programs (HRP). In order to receive a JCI certification, the hospital or other healthcare facility is required to continuously meet its standards, measures, and indicators, while undergoing re-evaluations every 3 years .
The Patient and Family Rights (PFR) section includes six major standards, which are further divided into the following additional standards:
The hospital is responsible for providing processes that support the rights of patients and families during care;
Patients are informed about all aspects of their medical care and treatment, and participate in care and treatment decision;
The hospital informs patients and families about its process for receiving and acting on complaints, conflicts, and differences of opinion about patient care and the patients’ right to participate in these processes;
All patients are informed about their rights and responsibilities in a manner and language they can understand;
General consent for treatment, if obtained when a patient is admitted as an inpatient or is registered for the first time as an outpatient, is clear in its scope and limits;
The hospital informs patients and families about how to choose to donate organs and other body tissues.
Other than the PFR section, the JCI recently initiated a patient safety campaign entitled “Speak up for your rights”, which is derived from the concept that patients have the right to be informed about their care and make related decisions. The campaign provides healthcare facilities with a range of materials to be given to their patients and families, so they may become active in their own healthcare. Launched in 2002 and updated regularly since then, this campaign includes infographics and animated videos on various topics, including anesthesia and sedation, depression, medical imaging, etc. .
Accreditation of healthcare institutions in Israel; a revised model of regulation
The Israeli accreditation project began as a voluntary process, initiated by Clalit Health Services in 2005. As the largest healthcare organization in the country, Clalit implemented the process in its hospitals, with the aim of improving the quality of care provided to its insured patients. Seven years after first introducing accreditation, with all eight of Clalitt’s hospitals successfully receiving the JCI certificate and with reported improvement in their quality of care , the Ministry of Health issued an administrative guideline requiring all general hospitals in Israel to receive JCI accreditation certification – as a prerequisite for their receiving their renewed hospital license .
By doing so, the Ministry of Health granted the JCI official regulatory authority over the national healthcare system. As stated in the Ministry’s guidelines, this mandatory accreditation was announced “due to the advantages of working in line with valid international standards for improving the quality and safety of the care” . This guideline constituted a major shift in the nature and purpose of the accreditation process in Israel from a voluntary venture initiated by one healthcare organization to an official mandatory requirement for licensing . Since then, accreditation of hospitals has thus become a model of integrated regulations within the healthcare sector [35, 36]. Integrated regulation is of “A form of extrinsic motivation where identified strategies are congruent with the person own values and needs.” . Since healthcare organizations aim to provide safe and high quality care, a regulation requiring that hospitals meet the standards of an external accreditor is a model of integrated regulation within health care.
While state licensing generally aims at ensuring minimal service standards are met by each organization, as defined by the legislator, the JCI accreditation process aims at ensuring optimal standards of service. This shift in the regulatory model reflects the Ministry of Health’s recognition of JCI’s optimal standards rather than sufficing with minimal standards as in the past . Despite this significant shift from minimal standards to optimal standards, healthcare officials, policy makers and legislators have not addressed its potential meaning and implication so far.
Importantly, as of 2018, JCI certification has been granted to 29 general hospitals in Israel, including five Palestinian hospitals in East Jerusalem .
Patients’ rights in Israeli law
The concept of patients’ rights first gained formal recognition in Israeli law in the mid-1990s, following the legislation of two main laws: The National Health Insurance Act (NHIA) in 1995, and the Patient’s Rights Act (PRA) in 1996. The NHIA specifies the fundamental principles that guide the operations and funding of the Israeli healthcare system: Justice, equality, and mutual assistance (i.e., solidarity). The law also affirmed the fundamental right to receive medical care with public funding of services that are included in the medical basket, and the consequent obligations of the state to fulfill this right . The PRA then introduced a relatively elaborate bill of patients’ rights, reflecting principles previously determined in case law. These included: The right to receive medical care; the right to receive treatment without discrimination; the right to receive professional and humane treatment; the right to receive information regarding the identity of the caregivers and their role; the right to seek an additional opinion; the right to have an escort in every medical examination; the right to continuity of care; the right to medical confidentiality; the right to receive information and to review the medical records; and the right to give informed consent. The PRA also required establishment of an ethics committee in each medical institution and granted them legal authority for implementing the law and resolving possible rights-based conflicts [40, 41]. The endeavor to create a legislative patients’ rights scheme was continued in 1998 with the enactment of Equal Rights for Persons with Disabilities (ERPDL). This later developed into the right to equality in healthcare.
Over the following decade, additional rights were given formal recognition. For example, the Dying Patient Act (DPA) of 2005 and the Organ Transplant Act (OTA) of 2008 both addressed end-of-life related treatment. DPA focuses on patients’ rights during the final 6 months of their lives, acknowledging patients’ right to refuse life-prolonging treatment. While it refers to patients’ families as their proxy, this act does not view the family members as having related legal standing . The OTA granted specific rights to both organ donors and their family members with regards to giving consent to the donation and establishing incentives for this purpose. While family members may still refuse to donate despite the explicit wishes of the deceased, PRA emphasizes and prioritizes the patients’ autonomy and privacy, and does not view the family members as having legal standing regarding the patients’ health and care [43,44,45].
Israeli courts also contributed to the establishing of patients’ rights, prior to and following the introduction of Patients’ Rights Laws. Courts developed the content of the right to healthcare [46,47,48], the rights of patients’ autonomy [49,50,51], and informed consent [49, 52, 53].
Even though the law officially protected patients’ rights since the 1990s, and successfully introduced mechanisms and tools that promote rights within the healthcare system [41, 54], there were several barriers to full implementation and enforcement of the legislation. First, doctors and other medical practitioners, were insufficiently informed  and were reluctant and hesitant. They perceived the law as vague , intervening in their clinical work [57, 58], and difficult to implement [57, 59]. Similar concerns were raised by the State Comptroller in his 2015 annual report . The report reviewed the actions taken by the Ministry of Health to promote and protect patients’ rights and found them inadequate in safeguarding patients’ dignity and privacy. The report marked a disparity between hospitals as one of the main setbacks in implementing the PRA in Israel. It identified inconsistencies between healthcare providers and underlined the significance of standardizing procedures and protocols that protect patients’ rights, such as informed consent forms .
In summary, patients’ rights are essential for excellent healthcare performance. This is reflected in various accreditation models and reports . However, to date, research has hardly focused on the implications of accreditation on patients’ rights in the healthcare system . Accordingly, we have designed this research specifically to examine this important issue.