By Oliver Matthias Kipf, Software Lead EU MDR Program, Philips
In this second article, I discuss key ideas and concepts underlying the design of a Reference Architecture for Health. Based upon the principles developed in the first article, these ideas and concepts describe what is needed. Together with the essential capabilities that we will introduce in a third article, they provide the input to how to build and deliver such a Reference Architecture. This document uses the following approach:
- From the large to the small: Start with the outer context, the overall Healthcare system, and refine into individual subject areas and building blocks
- Outside in: Start outside the organization, from the perspective of a customer, and design your organization around the needs of the customer
The Healthcare Landscape
In this document, I will use the Healthcare landscape that I introduced in the first article. At the center of this landscape is the person seeking health, surrounded by health system building blocks (health worker, information, governance, etc.). An outer ring contains organizations, such as care providers (hospitals, day care facilities, etc.), manufacturers of medical devices, or producers of pharmaceutical products.
Figure 1: Healthcare Landscape
Architecture Building Blocks
We start with the delivery of reliable high-quality health services to promote healthy living, prevent disease, diagnose and treat, and help rehabilitate or provide supportive care where needed:
Figure 2: Map of Health Services
The two-dimensional map shown in the previous diagram, tells us who provides what and when, where and how. Its horizontal axis displays the service domains across the continuum of care (what and when); its vertical axis outlines the corresponding delivery domains (where and how).
Take an example:
A hospital uses various point-of-care technologies, such as monitoring devices, or infusion pumps, which connect to a Clinical Decision Support (CDS) system that manages the clinical workflow. The CDS integrates with the Hospital Information System, which the hospital in turn uses to communicate with external parties.
The space-time map allows us to associate health services and their connected processes to delivery organizations along the patient journey, as shown in the following diagram:
Figure 3: The Patient Journey
Architect for Health Services
Support the modeling of health services and their associated processes across space (delivery domains) and time (service domains).
When caregivers team up to deliver care, they form a partner network along the patient journey.
Organizations in the healthcare space, such as Integrating the Healthcare Enterprise (IHE), successfully apply this concept in their integration profiles.
Design the Partner Network
Support the partner network for the delivery of healthcare, use of technology, commercial viability, regulatory compliance, and adherence to quality.
We can further use the two-dimensional map to clarify the scope of our reference architecture: To help architects and planners define where they want to be (how the architecture of a concrete organization and partner network should look like), and how to get there (a way of working) – at the level of an individual organization and across the partner network:
Figure 4: Scope
Blueprint and Development Method
Provide a design blueprint for a single healthcare organization (hospital, day care facility, rehabilitation facility, etc.) and its partner network; and establish an architecture development method for healthcare.
Delivery domains allow us to determine architecture archetypes (the how) required for health, as shown below:
Figure 5: Archetypes
Take for example a patient in the intensive care unit, connected to a point-of-care bedside monitor. If the device detects a critical situation, such as a sudden drop of blood pressure, we need to ensure the care team can react to this event in a timely manner. If, at a later point, the care team decides to order additional diagnostic tests, we need to support the workflow and enable the team to send a corresponding service request to an external laboratory to perform the test.
Support architecture archetypes for event processing, supply chain management, and collaboration through services
Healthcare Supply Chain
The healthcare supply chain ensures we deliver the right product, to the right customer, at the right time, in the right configuration, and through the right delivery channel. The following two-dimensional map describes supply chain actors who deliver goods and services, and supply chain domains to determine who receive them:
Figure 6: Healthcare Supply Chain
Healthcare Supply Chain and the 5R’s
Enable the modeling of supply chains in support of the 5R’s: right product, right customer, right time, right configuration, and right delivery channel
High quality care requires the right data, generated at the right time, and made available for the right purpose. Healthcare systems generate (lots of) health data in various locations and modalities, from the data captured in a mobile health application, to data generated via magnetic resonance imaging in a hospital. Irrespective of its source, we need to share and exchange health-related data across the patient journey in a safe, secure, and reliable manner, and in case of personal health data, safeguard its privacy. Our reference architecture has to ensure that data on a single person, or accumulated concerning multiple persons, can flow within and across episodes of care; and to become truly actionable information; we need to harmonize and standardize its meaning.
Figure 7: Health Information Flow
Health Information Flow & Reference Model
Support the flow of information of the personal health record including related information, and the electronic health record including related information, in a secure and reliable manner; provide an information reference model to allow mapping of information elements from various sources.
Healthcare systems are highly regulated. Whether to comply with software development standards, or ensuring patient safety and data privacy, organizations in the healthcare industry need to adhere to a multitude of rules and regulations. Care providers (EN15224 / ISO9001 for Health), manufacturers (ISO 13485), and pharmaceutical companies (ISO 9001 for Pharma) face the additional task of operating quality management systems:
Figure 8: Compliance
Build for Compliance
Include Quality Management System elements and other regulatory elements, and provide a pathway for certification and accreditation.
Healthcare systems need to decide on who receives health services, what services are covered, and how much will be paid. Besides core financing, next-generation payer organizations provide vital services to patients, their sponsors, care providers, and other payers across the continuum of care:
Figure 9: Financing
Support the payer-to-patient partnership for a personalized health experience, to prevent, and better manage disease, provide predictive capabilities, and encourage patient participation. Support payer partnerships with additional healthcare actors (providers, sponsors, other payers).
Users and beneficiaries of a reference architecture must be able to ask the right questions, in order to get meaningful answers. Viewpoints provide guidance to address areas of concern common to the healthcare industry:
Figure 10: Architecture Viewpoints
Provide healthcare specific viewpoints for the delivery of healthcare, use of technology, commercial viability, regulatory compliance, and adherence to quality.
Architecture Development Method
First, do no harm is what every medical student learns as a universal principle. We need to live and breathe this spirit, whether we introduce a new service, modify a process, or maintain an asset. Key design aspects of strategic lifecycle and change management are:
- Introduce or modify elements of the architecture (service, process, asset, etc.) via controlled changes
- For every change, perform a risk (patient, health professional, organization, partner network) and impact assessment (safety, performance, security, etc.)
- Manage, reduce or eliminate every identified risk
- Ensure you can trace every change
ADM for Health
Provide an architecture development method for healthcare that supports strategic lifecycle and change management.
Example: Change at time 1 (t1)
Assume a hospital plans to introduce a new Electronic Medical Record (EMR) System and introduces new or adjusts existing clinical processes. The hospital needs to identify all affected elements, identify risks, perform impact assessments, plan for mitigation activities, and group the change elements in transformation package 1:
Figure 11: Strategic Change and Lifecycle Management at t1
Once approved, the hospital builds and delivers the required capabilities and sets them into operations via transformation artifacts 1. Once in operations, the newly introduced artifacts are set on a continuous improvement path.
Example: Change at time 2
Imagine that at a later point, our hospital needs to introduce several new health services. A new change cycle begins, with a second transformation package, and another set of transformation artifact. Once in operations, the hospital will have to add the new elements to the continuous improvement plan:
Figure 12: Strategic Change and Lifecycle Management at t2
Strategic lifecycle management, based on ADM for Health, thus becomes the central engine for healthcare organizations to manage change and continuously improve over time, as shown in the following diagram:
Figure 13: Strategic Lifecycle Management in the Continuum of Care
Disaster Response Management
Natural or man-made disasters, such as hurricanes, pandemics, terrorist attacks, or nuclear accidents, may cause interruptions to normal operations and require immediate measures. Disaster response management, based upon ADM for Health, provides healthcare organizations a framework to identify, protect, detect, respond to, and recover from a crisis:
Identify – Develop an understanding of major threats and vulnerabilities, determine the risk to patients, employees, and critical infrastructure elements (assets, system, data, etc.). Develop a command-and-control system and the necessary disaster response and recovery plans
Protect: Develop safeguards to vulnerable patients, employees and critical infrastructure elements; design and setup critical health services and processes for resilience. Use change management to control plannable modifications to services, processes, products, and infrastructure elements.
Detect: Identify an emergency/crisis situation; establish clear, accurate and timely communication to gain public awareness and trust; initiate response activities.
Respond: Take response actions; ensure safety and security of patients and hospital employees. Execute the response plan to maintain patient triage operations, surge capacity, ensure availability of health services, essential medical and surgical services (e.g. emergency care, urgent operations, maternal and child care), and continuity of the health organization’s supply and delivery chain.
Recover: Execute the recovery plan to restore capabilities and services that were impaired during an emergency/crisis; and mitigate a disaster’s potential long-term impact on the health organization’s operations.
At the level of an individual health organization, disaster response management needs to align with regional/nationwide disaster management, as exemplified in the following diagram:
Figure 14: Disaster Risk Management Cycle
A disaster, such as a pandemic, requires upfront analysis of treatment scenarios through detailed patient journey maps. At every step on a patient journey, they define entry conditions (sterilization, decontamination, etc.), required activities (clinical, non-clinical), personnel, supply chain (medicine, devices, and supplies), infrastructure elements, and exit criteria.
Once determined, you need to establish controls to ensure continuity of your supply chain, and the availability and capacity of mission-critical infrastructure elements.
DRM for Health
Include an approach and framework for disaster response management.
To give you a real-world example:
We, at Philips, are currently ramping up production capacity for monitoring devices at a scale never seen before. Together with ventilators, monitoring of vital signs is key to treat COVID-19 patients; and we expect huge challenges not only to initially deliver our devices [which is the easier part] but to ensure we provide necessary supplies and spare parts – this is very real!
About the Author
Oliver Matthias Kipf is a Process and Solution Architect and certified Master Architect. He provides thought leadership, innovation and architecture expertise in healthcare.
European Union, 2017: Regulation (EU) 2017/745 on medical devices: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
European Union, 2016: Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data; https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016R0679&from=EN
European Standard, 2017: NEN-EN 15224:2017 Quality Management Systems – EN ISO 9001: 2015 for Healthcare
Future Care Finland: P4 medicine and healthcare emphasizes predictive, preventive, personalized and participatory healthcare instead of reactive disease care. https://futurecarefinland.fi/en/p4-healthcare/
HITRUST, 2016: Healthcare Sector Cybersecurity Framework Implementation Guide. February 2016.
ISO International Standard, 2016: ISO 13485. Third edition 2016-03-01
IHE International: IT Infrastructure Technical Framework. https://www.ihe.net/resources/technical_frameworks/#IT
IHE International: Patient Care Coordination Technical Framework. https://www.ihe.net/resources/technical_frameworks/#pcc
IHE International: Patient Care Device Technical Framework. https://www.ihe.net/resources/technical_frameworks/#pcd
IEC ISO, 2015: IEC 62304 Medical device software – Software lifecycle processes. Edition 1.1 2015-06
OECD, 2011: A System of Health Accounts; http://www.oecd.org/els/health-systems/a-system-of-health-accounts-2011-9789264270985-en.htm
SCOR: Supply Chain Operations Reference (SCOR) Model.
The Open Group: Welcome to the Archimate® 3.1 Specification, a Standard of The Open Group: https://pubs.opengroup.org/architecture/archimate3-doc/
United Nations: Disaster Risk Management. http://www.un-spider.org/risks-and-disasters
US National Library of Medicine: National Institutes of Health – Using the World Health Organization health system building blocks through survey of healthcare professionals to determine the performance of public healthcare facilities; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5651704/
World Health Organization: National Health Planning Tools – Health System Building Blocks: https://extranet.who.int/nhptool/BuildingBlock.aspx
World Health Organization: Framework on integrated people-centred health services: https://www.who.int/servicedeliverysafety/areas/people-centred-care/en/
World Health Organization: Health Systems Strengthening Glossary: https://www.who.int/healthsystems/hss_glossary/en/index5.html
World Health Organization Europe, supported by The European Commission, 2011: Hospital emergency response checklist. An all-hazards tool for hospital administrators and emergency managers
World Health Organization, 2009: Hospital preparedness checklist for pandemic influenza. Focus on pandemic (H1N1) 2009
The author likes to thank his colleagues at Philips and the team of The Open Group Healthcare Forum for their inspiration; and above all, his family for their great support.