Towards an interconnected personal health system for the Dutch healthcare sector: Barriers and facilitators to implementation

health system for the Dutch healthcare

sector

Barriers and facilitators to implementation

by Debby Schleeper

(10327010)

Master Thesis

May 2017, Amsterdam Supervisors: Drs. Ir. T.H.F. Broens, Mentors: J. Hoogstra and R. Stroek.

University of Amsterdam Master Medical Informatics

Towards an interconnected personal

health system for the Dutch healthcare

sector

Barriers and facilitators to implementation

Debby Schleeper

Studentnumber: 10327010 Email: debbyjose@hotmail.com SRP tutor

Principle Investigator Tom Broens Department of Medical Informatics

Academisch Medisch Centrum (AMC) Amsterdam SRP mentors

Jan Hoogstra - Director KPMG IT Advisory – Risk Consulting Roy Stroek - Manager KPMG IT Advisory - Risk Consulting SRP address

KPMG audit and advisory

Department IT Advisory – Risk Consulting Laan van Langerhuize 1

1186 DS Amstelveen Period

ACKNOWLEDGEMENT

I would like to thank all my supervisors for all their guidance throughout my thesis. Without their support, I would probably not be able to finish this thesis.

In particular, I would like to thank my tutor Tom Broens for his guidance. Your suggestions, comments, detailed feedback on each Chapter helps me a lot. I would like to thank you for the time that you have

taken for me to explain all given feedback in person on your Friday afternoons.

Moreover, I would like to thank Jan Hoogstra in helping me making this study possible by KPMG. Your explanations, revisions, and comments really helped this study along. Also your positive attitude and

support during the project motivated me to go on. Thank you! Finally, I would like to thank Roy Stroek for his ideas and support at the beginning of this study. You had

some innovates ideas. Chris Hardesty for contacting this international network for my study. Hans Teunisse for his support and critical view of structure and grammar.

ABSTRACT

Introduction: The Dutch Healthcare system is transforming to a patient-centered care model. One of the

essential factors for patient-centered care is an adequate information supply around the patient. A Personal Health Record (PHR) could provide this appropriate information supply around the patient. In 2020 a PHR should be implemented and available for the citizen of the Netherlands. The aim of this study is to identify barriers and facilitators to implementing a PHR in the current Dutch healthcare sector.

Methods: Three studies are performed to identify barriers and facilitators for PHR implementation in

the Netherlands. First, a literary study is conducted to collect barriers and facilitators for PHR implementation. The barriers found were categorized into a framework. The second study consists of interviews with PHR experts in The Netherlands. The third study collects PHR implementation barriers and facilitators at international level with a questionnaire.

Results: Forty-one unique barriers and thirty-two facilitators for PHR implementation were identified by

the literature study categorized into a framework. Seven of the forty-one barriers for PHR implementation in the framework were also identified in the interview with the PHR experts in the Netherlands. In the international study with the questionnaire, eight barriers were collected for PHR implementation. Based on the results of the literature study and the international study four barriers were identified that are not yet identified for the Netherlands.

Conclusion: In total seven future barriers were identified for implementing a PHR in the current Dutch

Healthcare sector by this study. Those seven barriers are common barriers for PHR implementation. These barriers also occur internationally level and are discussed in the literary study. Three out of those seven barriers is the Netherlands aware of but are not covered by the current PHR project initiatives of the Dutch government and Dutch Patient Federation. These barriers are: (i) lack of trust in system privacy and security, (ii) Attitude of clinicians towards the system and (iii) Law and regulation of PHR. In addition to, those three barriers, we identified four new barriers in the literature study and the international study which were not yet identified for the Netherlands. These are: (iv): Utility problems, (v) Data integrity, (vi) Customize the PHR for different user-groups, (vii) Integrate the system in clinician’s workflow. The Dutch government and Dutch Patient Federation should play more attention on those seven barriers for PHR implementation. Facilitators and recommendations are given for each barrier to the Dutch Government and Dutch Patient Federation to overcome those barriers for PHR implementation in the current Dutch Healthcare sector.

SAMENVATTING

Introductie: Het gezondheidssysteem in Nederland is in een transitie fase naar een patiënt-centraal

zorgmodel. Een van de essentiële voorwaardes voor het realiseren van het patiënt-centrale zorgmodel is een adequate information omgeving om de patiënt. Een persoonlijk gezondheidsomgeving (PGO) kan deze adequate informatie omgeving voor de patiënt realiseren. In 2020 moet het PGO geïmplementeerd zijn in de Nederlandse gezondheidszorg en beschikbaar zijn voor de Nederlandse burger. The doel van deze studie is het identificeren van factoren dei van positieve en negatieve invloed kunnen zijn op de implementatie van PGOs in het huidige Nederlandse gezondheidssystem.

Methode: Drie studies zijn uitgevoerd om barrières en stimulansen te identificeren voor PGO

implementatie in Nederland. Als eerste is er een literatuur studie uitgevoerd om factoren voor PGO implementatie te identificeren. Vervolgens zijn er interviews met PGO experts in Nederlands uitgevoerd. De laatste studie identificeerde barrières en stimulansen voor PGOs internationaal.

Resultaten: Eenenveertig unieke barrières voor PGO implementatie waren gevonden in de literatuur

studie en weergegeven in een framework. Zeven barrières voor PGO implementatie zijn gevonden in de studie met de PGO experts in Nederland. De studie met de vragenlijst op internationaal niveau, heeft acht barrières voor PGO implementatie kunnen identificeren. Uit de resultaten van de literatuur studie en de internationale studie konden vier nieuwe barrières geïdentificeerd worden die nog niet waren gevonden voor Nederland.

Conclusie: In totaal zijn zeven toekomstige barrières geïdentificeerd voor PGO implementatie in

Nederland. Alle barrières waren ook gevonden in de literatuur studie en internationaal studie. Drie van de zeven barrières zijn niet opgenomen in de huidige PGO projecten van de Nederlandse overheid en de Nederlandse Patiënten Federatie. Deze zijn: (i) geen vertrouwen onder burgers in de privacy en security voorwaardes van het PGO, (ii) zorgen bij gezondheidsprofessionals over de toenemende werklasten bij het in gebruik nemen van het PGO, (iii) Wet en regelgeving omtrent PGO. Naast deze drie barrières zijn er vier nieuwe barrières gevonden die nog niet waren geïdentificeerd voor Nederland. Deze zijn: (iv) gebrek aan interesse bij gebruikers, (v) data integriteit, (vi) PGO interface afstemmen op behoeftes van de gebruikersgroepen, (vii) Het systeem integreren in de werkprocessen van zorgverleners. Aan de Nederlandse overheid en Nederlandse Patiënt Federatie worden voor alle seven de PGO implementatie barrières aanbevelingen geven.

10

INHOUDSOPGAVE

1.1 Dutch healthcare visions and mission ... 12

1.2 Problem description ... 13

1.3 Research objectives and questions ... 14

1.4 Research methods ... 15

1.5 Scientific research project address ... 17

1.6 Relevance of the research ... 17

1.7 Structure ... 18

Chapter 2: Background ... 20

2.2 Personal Health Record types ... 21

2.3 The purpose and functionalities of PHR ... 23

2.4 Data sources for integrated PHR ... 25

2.5 Quantified-self ... 27

2.6 Interoperability standards for PHR: ... 28

2.7 Framework foundation for implementing PHRs ... 28

2.8 Conclusion ... 30

Chapter 3: Literature study ... 32

3.1 Methods ... 32

3.2 Results ... 33

3.3 Discussion literature study ... 42

3.4 Conclusion Literature study ... 44

Chapter 4: fieldwork study: PHR implementation Netherlands ... 46

4.2 Results ... 47

4.3 Discussion: Fieldwork study interviews Dutch PHR experts ... 51

4.4 Conclusion: Fieldwork study interviews Dutch PHR experts ... 55

Chapter 5 Fieldwork study (2): PHR implementation international ... 56

5.1 Methods ... 56

5.3 Discussion ... 65

5.4 Conclusion ... 68

Chapter 6: General discussion ... 70

6.1 What are barriers and facilitators for PHR implementation in the literature? ... 70

6.2 What are the barriers and facilitators for implementing a PHR in the current Dutch healthcare system? ... 70

6.3 What are the barriers and facilitators for PHR implementation in other countries? ... 71

6.4 What are possible blindspots for the Netherlands? ... 71

6.5 Strengths and Limitations ... 72

6.6 Future research ... 72

12

CHAPTER 1: INTRODUCTION

This Chapter introduces the relevance and objectives of this research “an Interoperable connected personal health system for the Dutch healthcare sector: barriers and facilitators to implementation.” It outlines the current situation of the Dutch healthcare system and the problems that arise. This Chapter begins with an introduction of the problem description followed by the research questions and study objectives. The study methodology and introduction about the SRP address are also described in this Chapter. Chapter one ends with the study outline for the other Chapters.

1.1 DUTCH HEALTHCARE VISIONS AND MISSION

The Dutch government determined a new vision for the Dutch healthcare system (1-5). This vision describes that the Dutch healthcare system should transform to a patient-centered care model, i.e. care which is organized around the patient (3, 5). In this model, care providers work closely together with patients and families to identify and satisfy the full range of patient needs (6). The philosophy of putting the patient at the center of care stimulates healthcare services to fit better with the patients’ needs and provides more meaningful and valuable care to the patient (6). By placing the patient at the center of care, the patient will be engaged and empowered to take more responsibility for his or her care. One of the essential factors for patient-centered care is that all information on the patients’ health status is available for physicians as well as for patients. This will lead to a well-informed patient and physician who can take action based on the full picture. For this reason, it is important that there is one electronic health record that provides all health information of the patient and is interoperable within the healthcare system between patient and healthcare providers (3, 6, 9).

1.1.1 Current situation in the Dutch healthcare system

In the current situation in the Netherlands, there is no adequate information supply around the patient that supports the patient-centered care model of the Dutch government (3). In 2010 the State Congress of the Netherlands rejected the legislative proposal for a national electronic health record (10). As a result, electronic health information of patients is still distributed since there is no national electronic health record available. For the patient-centered care model, a complete overview of the health status of the patient essential (6). At this moment, all health information exchanges in the Netherlands are organized by a leftover division of the rejected national electronic patient records of 2011 (11). This organization is called “Vereninging van Zorgaanbieders voor Zorgcommunicatie” (VZVZ), and it controls and manages the national health information exchange in the Netherlands, Landelijk Schakel Punt (LSP). The LSP provides a reference index for routing, identification, authentication, and authorization of health information (11). The LSP has several barriers which prevent it from supporting the patient-centered-care vision:

• The LSP does not include all healthcare providers, which is a requirement for the patient-centered care vision (3, 6). At this moment, only general practitioners (GP), pharmacies and hospitals are connected to the LSP system (12). Furthermore, healthcare professionals are not obligated by law to make use of the LSP. As a result, not all healthcare professionals of hospitals, GP institutes, and pharmacies take advantage of the LSP infrastructure.

• Since 2013, Health information exchange by the LSP has been organized on a decentralized level (11). For patient-centered care, information exchange must be possible between all involved

healthcare providers of the patient (6). The Netherlands is divided in forty regions, which means that GP, hospitals, and pharmacies located in that same region are allowed to exchange patient information according to the LSP. If they are located in different regions they are not allowed to share health information with each other (11).

• The medical information in the LSP is only partly accessible for the patient to view. The LSP have the purpose to be a gateway for systems of Healthcare providers to exchange health information (11). It does not have the purpose of storing health information of the patient (12). It is also not possible for the patient to edit or enter health information which is collected by them-self in the LSP (11). Therefore the LSP does not support patient-engagement or patient empowerment, which is also part of patient-centered care vision of the Netherlands (3, 6, 13). The new information and communication technologies(ICT) of today provides opportunities to realize the adequate information supply around the patient for patient-centered care (14). One of those new technologies that can support the patient-centered care model is the PHR (7-9). A PHR is an electronic health record owned by the patient and provides one holistic overview of all the health information of the patient (9, 15). The record bundles all distributed health information of electronic patient records collected by healthcare providers. The PHR is shareable between the patient and the involved care providers via an interoperability platform (15). In the ideal World, the PHR system can also collect health information from self-monitor devices of patients for optimal support of patient engagement and patient empowerment (15).

1.2

P

The Dutch government formulated specific e-health policies to supportthe realization of PHR and patient portals (3). This e-health policy mentions IT goals which should be realized by the PHR and patient portals to support the patient-centered care model. This e-health policy included the followed goals:

1. Access to medical information: In 2019, 80% of the chronic patients and 40% of the Dutch

population should have direct access to their medical record, medication-information, vital functions and lab results (3).

2. Quantified self: In 2019, 75% of the chronic and elderly patients in the Netherlands must be able to perform self-measured. This self-measured data must be shared by PHR or patient portal with their healthcare professionals. For example, blood pressure or heart rate measurements (3).

3. Online communication with healthcare professionals.: In 2019, it should be possible for people that receive care at home, communicate with their healthcare professionals according to live-stream 24 hours a day (3).

4. PHR implemented in Dutch healthcare sector: In 2020, the PHR should be implemented in the Dutch healthcare sector and be available for each citizen in the Netherlands that want to make use of the PHR for managing their care (3, 16).

The annual e-health monitor of the Netherland reported that only 10% of the chronic patients has insight into their medical record of one or more healthcare providers (17, 18). The elderly patients had

14

2% till 4% insight in the medical record by care providers. The second e-health goal is realized in only 4% of the hospital patients and 8% of the GP patients(18). Real-Time online communication is realized in 5% in the Dutch population (18). The e-health monitor report and the Minister of Health, sport and wellbeing concluded that the implementation, use, and up-scaling of e-health innovations that support an adequate patient-centered electronic health information environment is behind schedule (17). The Patient Federation of the Netherlands also published a report about the current PHR platforms in the Netherlands (19). Seven PHR platforms were identified and evaluated about their functionalities. The report concluded that not one of the seven Dutch PHR initiatives fulfilled the requirements of a patient-centered PHR system (19). They also found that the Dutch PHRs are lagging behind in quality and functionality with PHRs implementation in comparison to countries such as the Sweden and Denmark. In 2016, the Dutch e-health monitor reported that only 2% of the chronic patients made use of a PHR and 2% did use PHR once in the last year (18).

1.3 R

In 2020, PHRs should be fully implemented in the Netherlands in order to realize the e-health goals and support the patient-centered care vision (17, 18). To overcome problems in PHR implementation in the Netherlands, more insight and knowledge into the underlying patterns and complexities of PHR implementation is needed. Therefore, factors that influence the implementation should be investigated. The research objective of this thesis is to identified current barriers and facilitators to implementing a PHR record for the Dutch healthcare sector. Furthermore, this study could support the Dutch government and Dutch Patient Federation by implementing a PHR in the Dutch Healthcare sector. The Dutch government in collaboration with the Patient Federation of the Netherlands works on the project MedMij. The project Medmij is founded in 2016 and take care of factors that influence the implementation of PHR in the Netherlands. This research will provide an overview of the current barriers to implementing a PHR in the Dutch healthcare sector and will identify future barriers for PHR implementation. These aims resulted in the following research questions:

Main research question: What are the future barriers and facilitators to implementing a personal health

record (PHR) in the current Dutch healthcare system?

Sub-questions

• What are the general characteristics, functions, and types of personalized health records? • How to construct a framework for PHR implementation?

• What are the barriers and facilitators of PHR implementation in the literature? • What are the barriers and facilitators for implementing a PHR on a national level? • What are the barriers and facilitators for implementing a PHR at an international scale?

• What recommendations can be given to the Dutch Government based on the identified barriers and facilitators for implementing a PHR in the current Dutch healthcare sector?

1.4 R

This research is organized into four parts. Those four parts are described according to the techniques by

Doorewaard and Verschuren (20) in Figure 1. Figure 1, provides an overview of the research methods used in this study. The research methods consist of a theoretical part and a qualitative part. In figure 1 the qualitative part is represented by the textboxes with line interruptions. The theoretical part consists of two parts. 1) an exploratory research used to identify the concepts of the PHR, Electronic Medical Records (EMR) and implementation frameworks for electronic patient records. 2) An in-depth literature study in which, the facilitators and barriers for implementing a PHR will be identified. With the results of the literature study, a theoretical framework for PHR implementation will be constructed. The qualitative part consists of two fieldwork studies. The first fieldwork study includes interviews with PHR experts in the Netherlands to verify the results for the theoretical part and collect new barriers and facilitators. The second fieldwork study consists of a questionnaire of qualitative questions that collects barriers and facilitators from PHR experts international. In the third part of the study, the results of the theoretical part and the practical part will be merged in a general discussion and conclusion. In this part, the framework for PHR implementation will be completed, and the barriers, specifically for the Netherlands will be discussed. The last part of this study provides advice with a recommendation of implementing a PHR in the current Dutch healthcare sector.

16

Verified PHR

framework _{Barriers and}

facilitators Netherlands

Verified PHR

framework Barriers and

facilitators international Identify future barriers for PHR implementation Netherlands Complete PHR framework Overall structure PHR framework Merged results of three studies and compare results to identify future barriers and facilitators for implementing PHR in the Netherlands Advice and recommendations for Dutch government regarding implementing PHR in the current Dutch healthcare sector Concepts definitions PHR, EMR and EHR

Overall structure framework PHR implementation

In-depth literature study to identify barriers and facilitators

for PHR implementation

Fieldwork study: questionnaire send to PHR experts in eleven

countries.

Fieldwork study: Interviews with PHR experts in the Netherlands

17

1.5 S

This research is executed in collaboration with KPMG NL. KPMG is a global network of independent member firms offering audit, tax and advisory services (21). Nowadays, it is one of the largest accounting firms of the World (21). KPMG is active in industries like financial services, industrial markets, Government and Healthcare, Consumer Markets and Technology- Media and Telecommunications. 1.5.1 KPMG Healthcare

KPMG firms deliver a broad range of audit, tax and advisory services in the healthcare industry. Clients in the healthcare industry include healthcare policy-makers, providers in primary, secondary and tertiary care organizations. Each country has their independent healthcare department that provides specific services that are relevant to the needs of the culture and health care systems of that country. The healthcare IT department in the Netherlands is divided into management consulting and risk consulting IT. KPMG Global has a health and life science department that connects the independent member firms of the different countries to an international healthcare network (22).

1.5.2 KPMG Risk Consulting IT advisory healthcare

This study was performed by KPMG NL department Risk Consulting health IT advisory. Risk consulting specified in health IT is focusing on managing and monitor health IT applications (23). KPMG NL Risk Consulting healthcare IT advisory is active in the area of software selection, implementation of electronic patient records, assurance and service procedure, IT strategy, and project management.

1.6 R

This research identifies the barriers and facilitators to the implementation of PHR. Those factors that influence the implementation will be worked out in an implementation framework with recommendations that are relevant for Dutch government that want to implement a PHR. The relevance of the research can be distinguished in practical relevance and theoretical relevance.

1.6.1 Practical relevance

The research is practically relevant for the Dutch government and Patient Federation of the Netherlands regarding the project Medmij. Futhermore, KPMG NL Health IT advisory provides strategic advice about implementing e-health applications for healthcare clients. The practical implementation framework with recommendations could support KPMG in provide their advice and hopefully improve the quality and efficiency of PHR implementations. Furthermore, PHR are a relatively new topic for KPMG NL. KPMG NL could also use this research for the further development of their vision and strategy for PHR implementation.

1.6.2 Theoretical relevance

In 2011, a scope of the literature about personal health records was executed by Archer et al. (24). They concluded that there is a gap in the literature of evaluation studies that measure and monitor the results of PHR implementations. The book “Evidence-based health informatics” reported that there is in general a gap in the literature of high-quality evidence in health information evaluation research (25). Mostly, health information technologies will be developed and implemented, but to a lesser extent evaluated. This study evaluates the implementation of PHRs that bridge the gap in the literature of evaluation studies and in particular for PHR implementation. Secondly, in the literature, no framework

18

supports PHR implementations (26, 27). This study set the first step in the development of an evidence-based PHR implementation framework.

1.7 S

This report includes six Chapters. Figure 2 shows an overview of the six Chapters. For each Chapter in Figure 2. the content is represented. Chapter 2 describes background information about personal health records and construct the main divisions for the PHR implementation framework. Chapter 3 contains the in-depth literature study. The barriers and facilitators from the literature will be collected, and the framework will be constructed. Chapter 4 and Chapter 5 belongs in the qualitative part of the study. In Figure 2, the qualitative part is represented by boxes with interruptions lines. The two fieldwork studies will verify the theoretical framework. New barriers and facilitators will be collected for the Netherlands, and the framework will be completed. The last Chapter, is Chapter 6, the general discussion and conclusion of the study. In this Chapter, all the results of the three different studies will be merged, and the total framework will be represented. The main research question will be answered, and advice on PHR implementation for the current Dutch healthcare sector will be given.

Chapter 6: General Discussion

Advice and recommendations for implementing PHR in

the current Dutch Healthcare sector Chapter 5: Fieldwork study Questionnaire international Chapter 4: Fieldwork study Interviews Dutch PHR experts Chapter 3: Literature study Overview of the literature Chapter 2: Background Information PHR and Framework structure

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CHAPTER 2: BACKGROUND

This Chapter contains background information about the concept PHR. The information within this Chapter will also serve as a basic structure for the PHR implementation framework. This Chapter begins with a brief overview of PHR definitions, types and functionalities. Also, the similarities and differences between PHR, EMR, and EHR are described. Followed by, interoperability standard for PHR and their relation with quantified-self devices. This Chapter will end with a literature search and comparative analyses of existing PHR implementation frameworks. The results of the comparative analyses will be used for the basic structure of our framework.

2.1.1 Personal health record (PHR) definition

In the literature, there is an absence of a uniform standard definition of the concept PHR (28). The definitions of PHRs difference in aim, ownership, and functionalities. Most articles used one of the two definitions below or formulated by themselves a new definition. The definition that is widely used in papers on the subject is the definition of the Markle Foundation:

‘‘The personal health record is an electronic application through which individuals (the patient) can access, manage and share their health information, and that of others for whom they are authorized, in a private, secure, and confidential environment “(15)

This definition by the Markle Foundation is a broad definition. The limitation of this definition is that it does not describe clearly who has the ownership of the data in the PHR. The American Health Information Management Association (AHIMA) and HIMMS described the personal health records as follows;

“An electronic Personal Health Record (“PHR”) is a universally accessible, layperson comprehensible, lifelong tool for managing relevant health information, promoting health maintenance and assisting with disease management via an interactive, common data set of electronic health information and e-health tools. The PHR is owned, managed, and shared by the individual or his or her legal proxy(s) and must be secure to protect the privacy and confidentiality of the health information it contains” (29-31)

This definition describes in more detail the concept of the PHR. In this definition, it is clear that the patient maintains and owns the record. Secondly, the HIMMS and AHIMA see the personal health records as a lifelong tool, which is not explicit mention by the Markle Foundation definition. Both PHR definitions mention that the PHR does not replace the legal record of providers, like an electronic patient record (EPD), electronic medical record (EMR) and Clinical decision support. For our study, a combination of the two definitions is chosen. The Personal health record definition that is constructed for this study is:

Definition 1. “The personal health record is an electronic application through which individuals (i.e.

patients) can access, manage and share their health information, with and from others in a private, secure, and confidential environment. Patient is in control of their health information and can authorize others to view, retrieve, process and augment this information.”

This definition is constructed mainly on the Markle Foundation definition with additional functions of the HIMMS and AHIMA definition. The Markle definition is widely implemented and often used in the literature. The definition of the HIMMS and AHIMA is not yet completely implemented. This could

21 provide problems for the literature research because by to specifically chosen definition fewer studies could be included. With the HIMMS and AHIMA definition, it will also be difficult to find enough experts for the qualitative part with the fieldwork studies.

2.2 PERSONAL HEALTH RECORD TYPES

In the literature, the division of types of PHRs is based on their interoperability with other systems (13). The individual (patient) has the possibility to create the interoperability of the PHR by themselves by using applications and commercial web applications. The types that could be identified based on the chosen Personal health record definition are described below.

2.2.1 Standalone Personal health record

This type of PHR is a stand-alone web application that is not as such developed to connect with any other system (13). Standalone personal health records are for example a USB-device that offers an electronic (web-based) application to store and visualize personal health information (e.g. Fitbit with the Fitbit app). They can be seen as isolate islands (27).

2.2.2 Integrated Personal health record This type of PHR is connected with the information systems of the healthcare professionals and possible other IT systems. The integrated type can be divided in Tethered PHR and Interconnected PHR(15, 24)

• Tethered PHR or Patient portal connected to Electronic health record of care providers: This type of PHR is often offered by care institutions and is in the format of a website through which patients can access personal health information that is stored in the electronic health record (EHR) or Electronic medical record (EMR) of the healthcare professional (15). Some portals provide additional tools (requesting appointments, e-prescribing renewals)and communication tools (e-mailing their care provider). Patient data is under the physical control of the health care provider (9, 32).

• Interconnected personal health record:

In this type of PHR, the patient is the owner and the controller of his or her information (24, 27). The patient and the healthcare providers can be granted the opportunity to add or collect health data in the PHR record of the patient. The patient has the possibility to connect self-monitoring devices at the record. Figure 3 shows the interconnected personal health record based on the hub and spoke model of Kaelber et al. (26). By hub and spoke architecture of Keebler et al. is understood as a patient-controlled PHR. This Patient-controlled PHR is at the center and connected to different stakeholders who exchange data and interact with patients (26). The patient owns, controls and manages the PHR.

Table 1 provides an overview of all the different PHR types. For each PHR type the interoperability possibilities, data ownership, data sources and existed examples of PHR type is described.

22

Figure 3. Show the interconnected PHR. This type of PHR is owned, managed, and shared by the individual or a legal proxy. In the Figure the PHR system is showed with a hub and spoke architecture, with a patient-controlled PHR at the center connected to different stakeholders who exchange data and interact with patients (26). The interconnected PHR supports the best the patient-centered care model (9, 26).

Table 1. Types of Personal Health Record

Personal health records

Integrated PHR Standalone PHR Interconnected Patient portal Standalone PHR

Interoperability e-health devices of the patient EHR or EMR of healthcare

providers

Only EHR or EMR of healthcare

providers Not interoperable

ownership Patient Health professionals Patient

Enters data Healthcare professionals and

the patient Some portals provide the Health professionals availability to the patient to enter some data by functions

e-prescribing, e-appointment booking, e-messaging for

patients.

Only the patient

Example of existed

systems My healththeVet of the US Department of Veterans Affairs.

MyChart from Epic Microsoft HealthVault or Google health

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2.3 T

PHR

2.3.1 Patient self-management

The purpose of the interconnected PHR is the ability for patients to manage, share, exchange, and collect data about their health (9, 13, 27). The PHR represents a repository of patient data and also include additional functionalities to help the patient in taking a more active role in their health. The general function of the PHR is (9, 13, 27, 28, 31, 32, 33,34):

• Access to medical data with capability to add personal information • Adding information of primary interest

• Medication checking • Refill prescriptions

• Retrieving laboratory results • Home-monitoring

• Patient-physician communication • Prevention reminders and education • Schedule appointments

• Patient education information

• Collect self-monitored data from Fitbits of the patient • Processing of claims and payments

The interconnected PHR accepts data obtained from the eHealth devices of the patient and health information data provided by healthcare professionals (38). Data collected from both sources improve the quality, completeness, depth of health information in the record. It provides the patient access to a wide range of health information, data, and knowledge. This can help the patient and the healthcare professionals to make well-informed decisions about the patients’ health (19). The access to their health data and knowledge will result in a higher patient-self engagement and more patient control (19). The information in the PHR can highly customize, which also support patient-centered care. For example, for the chronic patient different application could be added to the personal health record than for a patient with non-chronic diseases. Only the interconnected PHR which provide shared access to patient and healthcare providers achieves the full potential for patients in managing their health care (39).

2.3.2 Patient-healthcare professional communication

A critical benefit of integrated PHRs is that they facilitate an ongoing connection between patient and physician (34). It will be easier for the patient to contact their care provider. Synchronous and asynchronous communication can realize by PHR system. Some personal health record includes e-consults with their physician (24). The online communication between providers and patient will result in a more efficient use of time, potentially fewer office visits though the possibility of online consultations for in-person visits, and improve continuity of care through common access to test results (9).

2.3.3 One record for Information exchange between stakeholders

The PHR can merge all fragmented records by healthcare providers, which will lead to one holistic overview of the full health status of the patient (27). This will reduce the time clinicians spend gathering patient history and reduce the duplicated data. The PHR is portable because it provides one single

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interface that captures all health data from all sources and is accessible anywhere, anytime through the Internet (27). This facilitates exchange of health information within the healthcare system between all the involved stakeholders.

2.3.4 Education and lifestyle changes

A Personal health record could have an education towards healthier lifestyle changes (27). PHR could provide additional disease information functionalities and education tools for lifestyle changes. For example, diets and exercise programs can be added to the PHR. But also, e-Learnings modules to improve the knowledge and management of their diseases (13).

2.3.5 Cost reduction and improve health care delivery

The integrated PHR facilitates the exchange of health information among healthcare providers that are involved in the patient healthcare and thereby reduce extra transactions costs and lab tests (24, 9). It promotes a more efficient use of time and facilitates the transformation of in-person visits toward online consultations (9).

Figure 4. Provides a summary of the positive values the patients and consumers will have in using the interconnected PHR. The value of the PHR is described for the patient, healthcare providers, and patient-providers overlapping advantages. There is also a positive value for the community or society when the interconnected PHR system is implemented. The data in the records could be used for population research (35).

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2.4 D

PHR

The integrated PHR should be connected to multiple sources for collecting health and medical data about the individual (34). Data sources from healthcare facilities often reference to electronic medical records (EMRs), electronic health records (EHRs) and e-health devices of the patient himself. The difference between those concepts and their relation to PHR will be described.

2.4.1 Electronic medical records (EMR)

In the literature, there is also an absence of a unified EMR definition. In general, the EMR is described as the electronic version of the paper-based records of the patient within one single health organization (35). The record is not designed to be shared or to travel outside the healthcare organization. The EMR is owned and managed by the healthcare professional in practice. The EMR is used by providers for diagnosis, treatments and monitors daily health status of the patient. Information in the EMR could be for example medical history, diagnoses, medications, daily reports, and outcomes results of tests (36). This study identified the EMR as follow:

Definition 2. “The patient’s electronic medical record is the electronic version of the paper-based records of the patient. It is used by healthcare practitioners to document and manage healthcare delivery within a single healthcare organization”.

2.4.1.1 2.4.2 Electronic health record

For electronic health records, different definitions are also used in the literature. This study chooses the definition of the HIMMS, which is also commonly used in the literature:

Definition 3. “The Electronic Health Record (EHR) is a longitude electronic record of patient health information generated by one or more encounters in any care delivery setting. The EHR has the ability to generate a complete record of a clinical patient encounter- as well as supporting their care-related activities directly and indirectly via interface- including evidence-based decision support, quality management, and outcomes reporting”. The EHR confirms nationally recognized interoperability standards and that can be created, managed and consulted by authorized clinicians and staff across more than one healthcare organization”(35)”

Figure 5 Provide an overview of the concepts of the EMR, EHR and PHR and their relation to patient-centered care and data ownership. Figure 6. Provide a practical example of the use of PHR system by delivery care. The EMR contains the standard medical and clinical data gathered in one health care organization, a provider-centric record. Those EMRs are often not stored in the same structures and standards among different health care organization, which hinders the interoperability of EMRs between the various health care organizations (37). EHR are designed to contain and share information with other health care professionals across more than one healthcare organization. This makes the EHR a record that is focusing on the total health of the patient, patient-centric (35). The data in the EHR is derived from healthcare professionals and is often only accessible to healthcare professionals. System attributes of the EHRs often include patient demographics, progress notes, problems, medication, vital signs, past medical history, immunizations, laboratory data and radiology reports (38).

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Figure 5. Overview EMR, EHR and PHR with their relation to support patient-centered care model. This figure shows the relations between the EMR, EHR, and PHR. The PHR in Figure 5 is an interconnected PHR type. The PHR is owned and managed by the patient. The patient with the PHR is at the center and collects all the health information of the patient from the different sources. The EMR and EHR in the figure directly provide health information to the PHR. However, some EMR is first clustered in an EHR. It is possible that multiple EMRs are clustered in an EHR. The main difference between PHR and EHR is that the last one is under the custodianship of the healthcare providers. This figure is based on the Hube and Spoken model of Kaelber (26).

Test EMR Electronic Health record (EHR) EMR Test results Insurance company Pharmacy

Figure 6. Functional example of medication ordering with PHR. This figure shows a practical example how the PHR could be used in a care delivery process of medication. In this Figure the patient is sick and visits the GP. The GP orders medication for the patient at the pharmacy. The patient gets in his PHR the e-prescription of the medication. The patient visits the pharmacy for his medication. In the PHR the patient receives medication information about the medicine that will be provided by the pharmacy. The patient can monitor his medication intake. Feedback reports are sent to the GP and the pharmacy about the medication intake of the patient (16).

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2.5 Q

-

Quantified-self reference is the term that embodies self-knowledge through self-tracking(39). Through new technology and the internet, people will start their own data collections through self-monitoring and self-sensing technology (40). That self-monitoring and self-sensing technology are often mobile phones, smartwatches or wristband, which measure body temperature, blood pressure or oxygen saturation (41). For example, a smartphone can measure an asthma patient's lung condition by having a new type of microphone audio system that detects the lung condition by calculating the air flow rate and produces flow-time, flow-volume graphs (42). There are also applications like Water Your Body that tracks your drink behavior and reminds the user of drinking water every day or the application SkinVision that monitors the user skin condition and can detect in early states skin-defects (40). In the future, the form of the mobile devices will chance because of new technology. An example of this is Smart clothing which references to shoes and clothes with built-in body sensors (42). This personal data that the patient collects with their clothing can be valuable data in detecting health risks. This personal data might be available for healthcare providers in the record of the patient (27). The PHR offers a repository where this personal health data can be stored and be available for healthcare providers (27). Figure 5 describes the PHR in relation the devices of the patient according to the literature review by Roehrs et al. (27) .

Figure 7. Provide an overview of the interconnected personal health record linked to his data sources. The interconnected PHR can be seen as a data repository hub that stores personal data from the wearable devices of the patient and stores information from the information systems in the organization domain. The organization domain includes in this figure healthcare providers, healthcare insurance and government (27)

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2.6 I

PHR:

To provide interoperability, PHRs must support the same communications, and content encoding standards as other health information systems. The standards should support the functionalities of the PHR. General functionality includes providing (1) a clinical summary to the patient after each visit, (2) secure messaging between patient and healthcare provider, (3) ability to view, download, and transmit personal health record data, (4) patient-specific education, and (5) patient reminders for preventative care(32). Some PHR suppliers develop their own private standards and formats. The standards that are mention in this thesis are open public standards for PHRs. Based on the literature three groups can be distinguished; terminology standards, privacy standards, and structural and semantics standards (32):

• Terminology standards: International classification of diseases (ICD), Terminology collection of medical terms(SNOWMED CT), System of medical vocabularies(UMLS)

• Privacy: USA legislation for medical information (HIPPA)

• Structural and semantic: family of standards based on the HL7 model (HL7 FHIRE/SMART), ISO TR (Technical Report) 14292 (PHR), ISO/IEEE 11073 Personal Health Data, DICOM, and EHR standards in Europe(EN 13606) and accurate for exchange clinical documents (CCD)

2.7 F

PHR

This thesis will identify barriers and facilitators for implementing PHRs for the current Dutch healthcare sector. The results of this thesis will be an implementation framework for PHR systems with additional recommendations for the Dutch Government and The Dutch Patient federation. The framework will be a practical tool for supporting Policy-makers or Chief Information Officers(CIO) by implementing a PHR. The framework foundation is needed to supports a systematic approach for data collection in the literature study. Without a framework foundation for data collection in the literature an endless collection of factors that influence the implementation will be extracted. By choosing the main divisions(foundation) for the framework data can be extracted from the literature in a more detailed manner. A well-designed IT implementation framework must include the following elements in their framework (25):

• Context: the social, organizational and wider environment in which the implementation takes place.

• Content of technology: the characteristics of the technology that is implemented. • Process: how the technology is introduced and the implementation is conducted • Outcomes: results of the implementation process

For the main divisions of the framework, an oriented literature search was performed to existed PHR implementation frameworks. Seven existing frameworks were included (43-49). Those existing implementation frameworks were analyzed and compared according to their available elements in social context, technical content, implementation process, and outcome monitor.

2.7.1 Results Comparison analysis of existing frameworks for PHR implementations.

Seven implementation frameworks were assessed on their available elements in social context, technical content, implementation process, and outcome monitoring. The IT implementation frameworks that include all the four elements were used for the foundation of our framework. Figure 8 provides an overview of the seven frameworks for IT implementation assessed on their social, technical,

29 process and outcomes elements. The frameworks that include all the items were the layered telemedicine implementation framework of Broens et al. (49) and the implementation framework of Khodja et al. (43)

2.7.1.1 The layered telemedicine implementation model

The layered telemedicine implementation model by Broens et al.(49) includes four overall classifications for telemedicine implementations. The overall classifications are policy and legislation, financing and organization, acceptance, and technology. The model by Broens et al. is based on the telemedicine implementations theory by Tanriverdi and Iacono (49). This determines factors for successful implementation of telemedicine devices. This telemedicine framework describes all the elements of Ammenwerth et al. and is therefore plotted in the middle of the graph in Figure 6. The framework is also very general and does not include much detail, which is a requirement for the primary divisions. 2.7.1.2 E-health evaluation framework of Khodja

The second framework, which includes all four elements of Ammenwerth et al.(25) is the e-health evaluation implementation framework of Khoja et al. (48). The implementation is described in phases, and each phase includes a detailed description for evaluating the implementation of the e-health system. Therefore, this framework is plotted in the middle of our comparison analysis in figure 8. For a complete overview of all frameworks, the seven frameworks are described and plotted in a detailed manner in the Appendix A of this thesis.

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2.8 C

The layered telemedicine implementation framework of Broens et al.(49) and e-health evaluation tool of Khoja et al. (43) meets the main criteria’s of Ammenwerth (25). The layered implementation framework identified four main categories: technology, people’s behavior and acceptance, financial and organizations issues, policy, and legislation. The category “security and privacy” was added as the fifth category by the researcher since the legalization proposal of a national electronic health record for the Netherlands was in 2011, rejected on the barrier lack of trust in system security and privacy prevention(10). For the implementation of PHR in the current Dutch healthcare sector security and privacy aspects must be taken into account by the implementation. Based on the framework of Khoja et al. the category governance was also adopted. In Table 2, the overall categories for our framework are described. The six overall categories reflect the parts which play a major role in the evaluation of IT implementation processes. The six overall categories identified in this Chapter will be filled in with barriers and facilitators from the literature from Chapter 3.

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CHAPTER 3: LITERATURE STUDY

This Chapter describes the methods and the results of the literary study. The aim of this study is to identified barriers and facilitators for PHR implementation in the literature. The six categories defined in Chapter 2 will be filled with the barriers. The most measured barriers in the literature are described in more detail in this Chapter. For those most measured barriers, the associated facilitators from the literature are also represented. This Chapter begins with the methods section of the literary study. After the methods section, the barriers and facilitators will be described. This Chapter ends with a discussion and conclusion, where also the PHR implementation framework is shown.

3.1 M

3.1.1 Literature search

Online databases searches were performed in PubMed, Embase, Cochrane Library and Google. The search strategy was constructed according to the PICO-model. In Appendix A the PICO is described. Table 1 in Appendix A described the search string that is used for PubMed. For the other databases, similar search strings were used. The search strategy included a combination of medical subject headings (Mesh-terms), title-abstract-words and free-text words. There is no Mesh-term for “implementation” therefore free-text words were used. The last step of the search was a general Internet search in Google. Searching was supplemented by scanning the reference lists of the included articles.

3.1.2 Selection of the studies

The selection of the studies is described according the Prism flow diagram in Figure 9. The selection of the studies was divided into four parts: identification, screening, eligibility, and inclusion. In the identification part, all the results of the four different databases were screened on title and on an abstract level based on the inclusion and exclusion criteria. The inclusion and exclusion criteria are described in Table 2 of Appendix B. After screening by title and abstract; the eligible articles were manually checked for duplicates. Any duplicate articles were removed. The next step to examine if the full-text of the eligible papers were available. If the full-text was not available, the paper was excluded. During the eligibility part, the full-text papers were read. If the papers were still eligible, the articles were included in this study. One researcher did the selection of the studies.

3.1.3 Data extraction

The data extraction was done according to the six categories that were selected in Chapter 2. The six categories were technical, social, financial and organization, governance, policy and legislation, security and privacy. Those categories reflect the subjects that play a major role in the implementation process. Barriers and facilitators were extracted together but registered in two independent data extraction Tables. Those tables are described in the Appendix B. For each identified barrier and facilitator for the framework, the source, and PHR type were also registered. Barriers were clustered according the main categories. Sub-categories were made in main categories during the data extraction. This was done to provide more overview in the framework.

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3.2 R

The search in Pubmed, Embase, Cochrane Library, and Google identified 594 articles. After reading the titles and abstracts, 510 articles were excluded. Of the 84 eligible articles, the full-text of two articles was not available, and four duplicates were removed. Seventy-eight articles remained for full-text review. First, title and abstract screening was conducted for the second time, which results that 36 full-text articles were removed. After the full-full-text review of the 42 eligible articles, 23 met all inclusion criteria and were included. The most common reasons for excluding an article after the full review was the absence of a precise definition of personal health records or factors for implementation were not clearly described. Figure 9 provides a flow-diagram of the data extraction for this literature study. 3.2.1 Study characteristics

The number of included articles for this study is 23 (13, 24, 26, 27, 29, 34, 50-67). The characteristics of the study are described in Table 1 in Appendix B Chapter 3. Four (17%) articles were systematic reviews, six (26%) articles were reviews of the literature, nine (40%) were qualitative studies, and three (13%) articles were theoretical studies. The three theoretical studies consist of a summary of the literature about the purpose of PHR, system functionalities and factors that influence PHR implementation or adoption. One (4%) theoretical study was a summary of the discussion by Symposium American Medical Informatics Association about the definition, functions, and barriers for PHR adoption. Eighty percent of the articles were published between 2010 and 2017. All the articles described barriers for PHR implementation. Eighteen articles mapped their barriers to facilitators. Fifteen articles reported factors about the implementation of interconnected PHR systems. Six articles were focusing on tethered PHR type. One article looked to only to standalone PHRs. The factors in these articles were described from different stakeholder’s perspectives. Three stakeholder groups were mainly used; patients, healthcare professionals and healthcare policy-makers. Eleven articles described the factors from all the three stakeholders’ perspectives. Five articles described factors from the perspective of the patient and seven articles described from the perspective policy-makers. The most barriers were found in the categories social, technical and governance. The category Social identified nine barriers, technical included seven and the category governance have eight barriers. The most measured facilitators were also found in the category social, technical and governance. There were less facilitators found in the category Financial(n=4), policy and legislation(n=4), security and privacy(n=5). In Appendix B Chapter 3, Table of study characteristics is showed.

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35 3.2.2 Barriers

The literature search identified 37 unique barriers in the 23 articles for implementing PHR. All 37 barriers found in the literature apply to the interconnected and tethered PHR types. Barriers that were not applicable to the standalone PHR type were for example lack of interoperability standards with EHR of healthcare providers or concerns by clinicians about the impact of the system on their workload. All barriers, from the perspective of the healthcare providers, were not applicable for the standalone PHR. In the Appendix Table 6, all 37 barriers in the framework as shown. For each barrier in the table, the sources (by article number) are described. The last column of the table shows which type of PHR the barrier applies to. The 37 barriers from the articles are categorized into six main categories of the framework foundations. To provide an overview in each main-categories, sub-divisions are made. 3.2.3 Facilitators

From the 23 articles, 18 articles mapped their barriers to facilitators or recommendations that could improve the implementation of PHR systems. Thirty-two unique facilitators for the implementation of PHR systems were found in the literature. All 32 facilitators found in the literature apply to the interconnected and tethered PHR types. The majority of the facilitators were found in the social (n=7), technical (n=12), governance (n=5) category. Less facilitators were found in the categories financial (n=3), policy and legislation (n=2), privacy and security (n=3). The 32 facilitators found in articles are described in the Appendix B Chapter 3 Table 7. The divisions and categories that were used for the barriers table are also used to represent the facilitators. Also for each facilitator in the Table, the sources (by article number) are also described.

3.2.4 Technical barriers

The category “Technical” in the framework refers to barriers that were related to the technical components of the PHR system. Seven technical barriers were collected from the literature. Those seven technical barriers are: lack of technical support, usability problems, Lack of interoperability standards for PHR, standardization EMR data, utility issues, data integrity problems and connecting quantified-self devices to the PHR. Table 2. The four most measured Technical barriers and their facilitators.

3.2.4.1 Usability

Usability problems with navigating through the system were the most measured technical barriers in the literature (27, 53-55, 60-64). This barrier applies to all stakeholders groups. Examples of navigating problems were difficulties within storing information or log in the system (27, 55, 62). This barrier results in slow adoption of the system or could lead that people will stop using the system (62).

3.2.5 Utility

Utility refers to the state of information types and functionalities in PHR being useful and needed for the users. Utility is essential to determine whether a function is useful( 9). If the PHR system provides only access to the medical data, many articles concluded that users stop actively using the PHR system after the going-live stage of the implementation (26, 34, 54, 56, 60,). There is one article that found an association between the number of data types available in the PHR and the increased volume of use (55). Appointment booking, refilling medication and e-consulting were mentioned as the most vulnerable functionalities to the patient for using PHR (55, 61, 64, 66). Also, the functionality that a family member or caregivers could enter the PHR was a positive factor for adoption (26).

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Table 2. The four most measured Technical barriers and their facilitators

Barriers Total number of Articles

Facilitators

Usability problems with navigating

through system 14 Involve end-users (patient and clinicians) in the development stage of PHR.

Lack of PHR interoperability standards 12 Develop PHR particular interoperability standard. A facilitator is a central coordination for the development of interoperability standards for PHR

Data integrity problems refer to the maintenance of, and the assurance of

the accuracy and completeness of data entered the PHR system.

12 Use electronic data transportation and automatic

update from EHR.

And add additional functionalities to stimulate patients to use the PHR frequently.

Utility issues 10 Add additional functionalities to the PHR. The only access to medical record provides no additional

value for the user. Services with increasing adoption of the system are appointments scheduling, medication refill and direct online communication with a healthcare professional. 3.2.5.1 Data Integrity

Data integrity refers to the maintenance and the assurance of the accuracy and completeness of data entered in the PHR system (53). Twelves articles reported that the data in the PHR was not up to date or complete (24, 34, 52- 54, 59, 60, 62, 64, 66). Which resulted in people adopting the system and then using it less. This barrier applies to patients and for the healthcare professionals. Often the patient had no time, motivation or interest in updating the record all the time (55, 60, 62). One option for less workload of entering data and keeping the system up to date is that data will be automatically transferred from other information systems into the PHR (34, 52, 61).

3.2.5.2 Lack of interoperability standards for PHR

The lack of interoperability standards specific for PHR system is reported in articles (34, 62, 63). Especially, the interoperability with EMR systems and with self-monitored devices of the patient is difficult (24, 59, 60, 62- 64). A facilitator is that the government coordinates the development of interoperability standards for PHR (34, 52, 62).

3.2.6 Social Barriers

The category “Social ” includes factors that were related to the behavior, knowledge, and skills of humans to the adoption and acceptation of the PHR system. Nine social barriers found in the literature: literacy, lack of trust in system privacy and security, workload increase, loss of an interpersonal relationship, digital divide, clinicians attitude towards the system, lack of interest, evidence-based medicine, and discrimination by insurance companies. In Table 3, the four most measured Social barriers are described with their facilitators.

37 Table 3. The four most measured Social barriers and their facilitators

Barriers Facilitators

Patient technical and medical literacy Technical training, workshops, eLearning modules about the system functionalities and medical terms. PHR translate term from clinical EHR to patient-friendly terms.

Provide links and tools to external educational resources to understand the medical information better.

Concerns by clinicians about increased workload Discuss workload with clinicians and redesign workflow and processes

Concerns by clinicians about th impact of medical notes

on their patients. Promotion of PHR by clinicians is the most import success factors for system adoption by patients.

Lack of trust in system security and privacy Provide during the implementation a transparent and clear communication about the security and privacy risks.

3.2.6.1 Literacy

Health and technology literacy issues were identified as important barrier for PHR adoption (13, 24, 27, 50, 53-55, 59-63, 65, 66). Literacy refers to the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions (13). This barrier was applicable for patient and healthcare providers. Training and workshops for patients and healthcare providers could reduce the problem and serve as a promotion tool for the use of PHR and awareness of PHR functionalities ( 12, 24, 27, 50, 53-55, 59, 60-63, 66).

3.2.6.2 Concerns about increased workload

The most measured barriers by clinicians were concerns about the growing workload by using the system (24, 26, 50, 52, 53, 55, 58, 59, 61, 63, 67). A facilitator was to discuss the workload and responsibilities which are related to the PHR with the clinicians and redesign workflows (24, 26, 50, 52 53, 55, 58, 59, 61, 63, 67). Futhermore, to make the clinicians aware of how to use the functionalities by delivery care was a facilitator to overcome this barrier for PHR implementation( 52,63).

3.2.6.3 Concerns by clinicians about medical note on their patients.

The barrier clinicians fear about the impact of medical notes on their patient was measured in ten articles(50, 54, 55, 56, 58, 59, 61,62,63, 67). They fear that patient health literacy could cause misinterpretation of the data, provoke incorrect entry of data, and overwhelm the user with too much information to handle (55, 56). Training and education about portal use should convince clinicians about purpose and advantage of the system ( 34, 53, 62, 63, 66). Promotion of the system by the clinicians was the most important factor for engagement and fast adoption of the PHR system by patients (50, 54, 55, 59, 60, 62, 67). Promotion of the system by clinicians was dependent on the attitude, knowledge, and beliefs of the clinicians about the PHR (59). Providers who actively encouraged their patients to sign in and used the PHR, increased the adoption of the system (62).

3.2.6.4 Lack of trust in system security and privacy

The lack of confidence in system security and privacy results that patients refusing to adopt or use the PHR system (13, 24, 27, 34, 51, 54, 60-65). This barrier could have strong relation to slow adoption rates

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by the users. Provide a clear and transparent communication about the security and privacy risks from the beginning of the implementation process, was seen as a facilitator for this barrier (50).

3.2.7 Financial barriers

The category “Financial” include barriers that were related to financial aspects that support a sustainable business model for PHR. Four financial barriers were found in the literature. The four barriers are: Sustainable business model, Governance support, Lack of evidence studies for cost-reduction and effectiveness of PHR types. The four financial barriers in the literature with their available facilitators are described in Table 4.

Table 4. The four most measured financial barriers and their facilitators

Barriers Facilitators

No sustainable business models. Redesign business process and made reimbursement for PHR services.

Uncertainty about cost savings by lack of positive

results by small projects Lack of success by small vendors brings uncertainty about cost savings. More research and pilot studies are needed on the effect of quality of care and cost reduction.

Lack of government investment and subsidy for PHR

initiatives The government should subsidize PHR initiatives and promote the use of PHR in the society.

Effectiveness of PHR type Support scientific research to the efficiency of both PHR types.

3.2.7.1 No sustainable business model

The main financial barrier for the realization and implementation of PHR is that there is no sustainable business model behind the system (13, 26, 34, 53, 58, 63, 66, 67) . This brings uncertainty and concerns by all stakeholders about the costs, investments, and wins of the system (66, 63). This hinders the implementation and broad adoption of the system. The main uncertainty sits in the fact that it is not clear who is going to pay for the PHR. In different studies, it was found that the patient is not prepared to pay for the system. Also, there is no reimbursement for the online services delivered by the PHR for clinicians (53, 58). One facilitator to work to new PHR reimbursements is that the work and business processes of the organizations should be redesigned and new business models about online care delivery should be developed (53). A real clear solution to this barrier was not mentioned in the articles. 3.2.7.2 Lack of evidence for cost savings by small projects

The lack of evidence for positive results regarding cost-saving studies hinders the implementation process (13, 53). If end-users could see the success and added value of the PHR system in small projects, the adoption of the system will improve with the users and the more people who are willing to pay for the system (55).

3.2.7.3 Government support subsidies

Healthcare organizations and healthcare providers take some risk when they invest in a PHR system because the PHR is a new concept and research on cost-savings are scarce (34, 51, 54). With subsidies from the government for PHR initiatives, the risk or threshold to invest in a PHR is lower (50). The Government could support small pilot studies that investigate PHR on cost- effectiveness (55).