1 Introduction
1.1 Telehealth and the transformation of healthcare systems
1.2 Patient safety in Telehealth
2 Theoretical framework for the approach to research into patient safety in Telehealth
2.1 Complexity and vision of the systems
2.2 Modeled in layers and safety as an emerging property
3 Characterization of the layers in a modeling of the complex socio-technological systems for Telehealth
3.1 General structure
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Layer 5: Healthcare Ecosystem in Society
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Layer 4: Healthcare Organization
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Layer 3: Telehealth System
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Layer 2: Entities Subsystems
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Layer 1: Components
3.2 Level 5: healthcare ecosystem in society
3.3 Level 4: healthcare organization
3.4 Level 3: Telehealth system
3.5 Level 2. Entities subsystems
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A patient protocol usually consists of periodically carrying out biometric measurements (arterial pressure, weight, pulse, ECG, spirometry, lipid profile, activity, etc.), and replies to questionnaires on symptoms or actions.
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Some biomedical monitoring equipment for personal use (sphygmomanometer, scales, pulse oximeter, thermometer, etc.) to carry out the measurements required by the patient protocol
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Communications equipment to carry out the periodical sending of protocol information. The equipment must be suitable to interact with the interfaces authorized by the technical platform.
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Residential homes, in which there is the possibility of attending the patients collectively by means of shared equipment, for example, patients with oral anticoagulation therapy who share the INR monitor and the communications equipment. The interfaces with this type of external resource may be applications based on the Web, designed so that a person responsible for the resource manages the patient collectives.
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Platforms for external monitoring that receive information of specific patient collectives, for example, patients with implantable cardioverter-defibrillator (ICD) monitored from a platform that authorizes the company providing the ICD. In these cases, the interface would be based on specific “middleware” that makes it possible to interoperate with the aforementioned external platform.
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Support to the deployment of the intervention providing resources to make it possible to train the health professionals, patients, families; the maintenance and management of the equipment; tools for monitoring of the compliance with patient protocols, etc.
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Support methodology of the experimental evaluation study by providing resources for the support methodology of the clinical trials and experimental studies. For example, drawing up and management of the documentation (Case Report Forms), applications for the Electronic Data Capture, services for the centralized randomization, recompilation and analysis of results, among others.
3.6 Level 1 components
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C1) People: including individuals, groups, and roles that perform in each “Entity”. For example, the people component of the Patient Entity is typically chronic patients and can include also members of the family or voluntary caregivers.
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C2) Environment: including physical site and infrastructures. In Telehealth the medical procedure takes place outside the institutional environment. The healthcare professionals are able to carry out their activities from different locations and in an asynchronous manner, even on the go. For their part, the patients can be seen in their homes or in another convenient place. Other subsystems such as the technological platform can be installed in healthcare institutions, be distributed or, at premises of external provider’s.
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C3) Technology: including hardware and software. The different Entity Subsystems use a wide range of technologies from smart sensors linked to wireless networks and telecommunications services, as well as complex software applications. These technologies must cover special requirements. For example the biomedical equipment used by the patients is different by conception and destination of use of the equipment operated by professionals in healthcare institutions. Personal devices require the minimization of size and energy consumption.
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C4) Data: this component refers to the different types of data, its codification, how it is saved, formats and rules for exchange in each Entity Subsystem. It includes signals taken by biomedical equipment or environmental sensors, images, audio, voice and free and structured text. Furthermore, it is made up of data compression, filtering, pre-analysis and detection of alerts.
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C5) Processes: the way in which things are done (theoretical and real), management models, protocols, report relationships, requisites for documentation, data flow, and relationship regulations.
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6) Organizational context: in which the operation of each Entity sub-system is performed, for example, type of healthcare coverage of the patients (public, private, state assisted); appointment of the professionals; ICT platform provision (centralized, external, in the cloud)
Subsystems | Components | |||||
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People | Environment | Technology | Data | Processes | Organization | |
Patient Entity | Chronic patients treated with oral anticoagulant therapy (OAT). Advanced age | Urban domicile Rural domicile Nursing home | Mobile terminal GSM WAP SMS Coagulometer | INR Reply Form Messages Text Voice | Measuring and sending protocol WAP form SMS | Madrid Regional Health System (SERMAS) |
Health Professional Entity | General Practitioner (GP) | Medical Office | PC Fixed and mobile Internet connection Software application | TWD Patient folder Evolution curves Alerts Medication Statistics | Care Protocol | Primary Care Madrid Regional Health System (SERMAS) |
Interventions Management Entity | Nursing, Sociology, Psychology Technicians | Office | PC LAN Internet Connection Fixed and mobile telephony Multimedia | Patient directory Planning Timetables Statistics Verbal communications Training materials | Protocols and guidelines supervision Patient education Help Desk Quality control | Carlos III Health Institute. Telemedicine Research Unit |
External Resource Entity | Formal Caregiver | Nursing home | Mobile terminal GSM WAP SMS Coagulometer | INR Reply form | Caregiver Protocol Caregiver training | Nursing Home Pozuelo (Madrid) |
Healthcare Information Entity | Health computing professionals | Research Office | Computer equipment Middleware | Patient Telehealth Records (PTHRS) Patient ID | Patient Telehealth Records (PTHRs) management Data security Technical and semantic communication interoperability with EHR | Carlos III Health Institute Telemedicine Research Unit |
Technological Platform Entity | Technologists | ICT Centre | Central station Web services Telecom Infrastructures | All above + ICT management data | Web Services design and implementation ICT Services provision | Carlos III Health Institute Telemedicine Research Unit |
4 Identification of areas of research for safety in Telehealth
Research lines/Analysis level | Objectives / Control parameters | Research Topics |
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Theory of CSTS Engineering in Telehealth | Scientific reference framework | CSTS Engineering methods and tools Dynamic Cognitive Networks Mobile Social Networks Resilience in Telehealth Systems |
Patient Safety at the level of Healthcare Ecosystem in Society | Quality of Life (HLYa) Epidemiological data Macro-economic data | eHealth Governance Legal and organizational interoperability Patient empowerment policy Vigilance policy for patient safety in Telehealth Safety standards Certification Legal and ethical issues Holistic approach for patient safety |
Patient Safety at the level of Healthcare Organization | Health outcomes Quality of Telehealth services Data of adverse events Economic data on Telehealth safety investments and operational costs. Costs related to adverse events Compliance with laws and regulations | Requirements Engineering for Patient Safety in Telehealth Implementation of vigilance policy Evaluation methodologies and tools for patient safety in Telehealth Organizational and semantic interoperability Integrated Models for patient safety at healthcare organizations |
Patient Safety at Telehealth System level | Data of system performance Quality of Telehealth services Data on adverse events Micro-economic data on patient safety implementation and operation Compliance with standards and guidelines | Systems design for safety Telehealth systems standardisation Semantic interoperability Organizational interoperability Safety management in Telehealth Vigilance tools |
Patient Safety at Entities sub-systems level | Adverse events detection and report Adherence of patients and professionals to protocols and guidelines Equipment and software compliance with safety and security standards Physical and environmental conditions at patient’s home Information on components change and performance | Secure patient and professional identification Tools and methods to measure and manage caregivers workload Decision support tools for healthcare professionals Accessibility and user interfaces Safety of personal devices and wearable Home devices interoperability Cloud safety for Telehealth applications Apps safety Non-invasive surveillance techniques Behaviour monitoring and data analysis Home systems reliability Energy issues Electromagnetic Compatibility at home |
Methodologies and tools | Support technologies and techniques | Data mining and Analytics Geographical Information systems (GIS) Digital simulation Modeling languages Methods and tools for Telehealth system redesign |