Unified Patient Health Record: Systems Design View

Authors and Contributors:

Michael Kremliovsky (primary author) Executive Director, Digital Health and Real World Science, Bayer.

Eric Malamud

Victoria Moy, CEO, Innovatio.health

Editors and Reviewers:

Elaine Hamm, PhD, Executive Director, AAIH

Shalini Trefzer, Microsoft

Joseph McMenamin, Cristian & Barton, LLP

Chuck Montague, PhD, Johns Hopkins,

Rita Gaspardi Baldoria, Roche

James Zanewicz, Tulane University

Executive Summary

The Unified Patient Health Record (UPHR) represents a transformative vision for healthcare, providing patient-centric, seamless access to health data across the entire healthcare ecosystem. This white paper explores the key requirements and design considerations essential for such a system. By leveraging achievements in healthcare interoperability, establishing robust attainable standards, and fostering global collaboration, we hope to encourage the development of a unified platform that enhances patient care, empowers individuals, and supports innovative medical research. Community-led care and the patient voice are critical for the unified data platform, potentially making the difference between sick care and health care. This paper outlines the foundational concepts, necessary legislative actions, and technical requirements to bring the UPHR to fruition, ensuring it serves as a backbone for healthcare services worldwide.

Introduction

The Unified Patient Health Record (UPHR) is a system designed to store and serve personal health information across the entire healthcare ecosystem. Such a system can provide patient-centric, uniform access to health data across all providers, support transparency of health service transactions, foster the development of quality metrics, and supply critical data for advancing novel solutions in healthcare and public health management. Unlike traditional provider management systems or electronic health records (EHRs), which are often fragmented and siloed, the UPHR aims to unify and democratize reporting and access to patient data, ultimately improving the quality of care. In our previous work, “Why is there currently no Unified Patient Record?” we explored the key challenges that prevent a unified patient record from being realized, including data fragmentation, technical hurdles, and complex legal and cultural issues. Building on this foundation, the UPHR outlined here seeks to address these obstacles directly, proposing a framework that could revolutionize healthcare delivery, promote continuity of care, and empower patients to take control of their health information and give the patient the equivalent of a seamless consumer experience.

The Concept

Several key concepts define the Unified Patient Health Record (UPHR):

1. Unified Patient Health Record is a structured aggregation of health data (electronic documentation) generated by all entities interacting within the healthcare system and pertaining to care for a particular patient.

2. Patient Ownership: The health record must be legally owned by the patient, with guardianship provisions where applicable. However, ownership also depends on where the record resides. Patients today often manage fragmented records on paper, lacking the benefits of interoperability. A unified digital platform raises key questions: Who funds it? Which jurisdiction governs it? How is it built? Public or payer-funded models, national frameworks, and public-private partnerships could provide solutions. These considerations are integral to the UPHR discussion.

3. Comprehensive Content: The health record shall contain comprehensive medical information generated by healthcare providers, essential for clinical decisions, including prescriptions, treatments, consents, medical summaries of visits, tests, diagnostic statements, hospitalization records, self-reported outcomes, and itemized billing statements. Existing and emerging technologies—such as wearable devices, ambient AI, and continuous monitoring tools—offer valuable insights into a patient’s lived experience. Integrating these data streams into the UPHR could enhance personalized care and provide a more complete picture of patient health.

4. Digital Signatures and Timestamps: Each record shall be digitally signed by an accredited healthcare or service professional and timestamped accordingly. Also, a history of all changes made to the records must be kept for transparency and regulatory compliance.

5. Condition for Reimbursement: Where third-party (“payer”) payment is expected, submission of the required information from the healthcare and insurance provider shall be a condition for reimbursement or payment for services. This will necessitate new laws or rulemaking. The requirement is envisaged as the main driver for adopting the UPHR procedures and creating transparency. This includes direct payments by the patients and caregivers where the submission of the related records clears the way for accepting the payment.

6. Service Audits: Appropriately completed medical records are foundational for service audits, enhancing the integrity of information and its correspondence to billing. During the early stages of adopting UPHR procedures (submitting data, reviewing/auditing data, receiving data, etc), incomplete health records are to be expected. In cases where cash is paid for medical services, a significant amount of information may go unreported due to a lack of incentives for providers who could avoid administrative expenses by declining to report. Patients may also choose not to report or have difficulty with the reporting system. Others, including the unhoused and those lacking the ability to connect to the health system, might also be left out. Mitigation of these border cases will require new regulations and local government support.

7. Patient Access: Except in cases where therapeutic privilege applies—a situation in which a healthcare provider may withhold specific information from a patient if disclosing it could cause harm—patients should have access to their data through web portals, mobile applications, or on request, in paper form. The security model shall minimize the risk of unauthorized access. Users (with proper permissions) should also be able to easily export records in standard formats for use across different systems or when a patient switches providers.

8. Dispute Mechanism: Patients can dispute the accuracy of recorded information and attach personal statements, labeled as such. UPHR is an official record subject to change controls, quality assurance, verification, and validation.

9. Public Funding: UPHR should be funded publicly to ensure fair access to health information.

10. Privacy and Security: UPHR management companies (authorized contractors for hosting and servicing underlying technologies) are responsible for securing patient information and protecting privacy in compliance with industry standards and legal requirements. The UPHR system should be built on zero-trust principles, ensuring that bulk access to patient-specific data is not possible.

At the same time, secure and privacy-preserving methods—such as anonymized analysis or federated learning—could enable the extraction of predictive and prescriptive insights from aggregated data. This would allow patients to benefit from a broader knowledge base while maintaining strict data protections.

11. Research Access: The public may allow access to anonymized aggregated and, therefore not individually identifiable health information for research and public health improvement, subject to public debate and approval of the technical specifications for data sharing. The data access can be associated with a fee which will help to offset the cost of the infrastructure lifecycle management

The outlined key concepts are suggested as guiding principles for the design of the UPHR. They are subject to adjustments and further specification as the thought process progresses.

Key Requirements:

Key requirements (KRs) reflect the design principles essential for UPHR logic and implementation. Certification processes, such as those detailed in the ONC guidance (2013), are critical to ensuring that UPHR systems meet the technical and security standards necessary for reliable interoperability. While key concepts guide the overall legal and structural framework for establishing UPHR, key requirements elaborate on the technical design:

Robust Authentication Methods: UPHR shall have robust authentication methods providing role-based access permissions.

• Zero-Trust Model: UPHR design shall follow a zero-trust model, ensuring stringent security measures. That is, UPHR requires strict identity verification for every person, device, and request trying to access data.

• Data Access Permission: Patient-specific data shall not be accessible without explicit patient consent. There shall be a small subset of the patient record that is accessible with implicit patient consent by healthcare professionals for cases when emergency treatment decisions must be made and the patient is in an unconscious state or an altered mental status.

• Modular Structure: UPHR shall have an expandable modular structure, allowing for scalability and adaptability.

• Extendable Data Structures: UPHR modules shall have extendable data structures and support multiple data modalities (e.g., EHR, clinical imaging, genomic data) to accommodate future needs.

• APIs for Users: UPHR shall expose APIs for different types of users, facilitating interoperability.

• High Availability and Protection: UPHR data shall be highly available, namely accessible with an extremely high degree of reliability regardless of hardware and software faults, scalable with demand, and protected from environmental disasters and coordinated cyber-security attacks.

• Comprehensive Patient Identity: The record ID shall be uniquely connected to the patient’s identity, ensuring accurate identification across systems. The identifiable patient health information shall be separated from the medical information and both domains must follow the zero-trust rule (Riplinger, 2020, Choudhury, 2020, Schreiber, 2024).

• Deidentification: A patient should be given the right to allow the de-identification of his or her medical record for use within aggregated databases for nonprofit or for-profit medical research, epidemiology research, or pharmaceutical research,

• Interoperability. Ensure all records are stored using standardized formats such as HL7 or FHIR, making data easily shareable across healthcare providers and systems. Certification guidance provided by ONC ensures that systems meet these standards, paving the way for seamless data exchange and improved patient care (ONC, 2013). The system should support data exchange between hospitals, labs, pharmacies, and other healthcare entities, regardless of their internal systems. Records must be accessible across different platforms (desktop, mobile, etc.) and compatible with various Electronic Health Record (EHR) systems.

The UPHR software will be developed following industry best practices, including secure development methodologies, compliance with interoperability standards like HL7 and FHIR, and adherence to regulatory frameworks such as HIPAA. Development will leverage the expertise and infrastructure of contracted large-scale providers to ensure high availability, scalability, and robust data protection. Correspondingly, by centralizing interoperability and patient data management, the UPHR will reduce the need for individual healthcare providers to develop and maintain their own patient-facing software and cross-provider interfaces, streamlining operations and lowering costs. At the same time, UPHR can serve as a backbone of the health information systems and offer its functionality for powering patient-facing applications. While many potential applications can be envisaged based on the described concept, it is important to focus on modernizing the existing practice of handling patient data and the immediate benefits to the healthcare ecosystem.

Foundational Benefits and Implications of the UPHR

UPHR will be a large electronic system covering a trillion-dollar market in the United States alone. Correspondingly, the number of use cases can be very large. Here, only a few use cases will be identified for illustration.

• Improved Continuity of Care. The current practice in clinical care documentation management is provider centric. Consequently, changing providers or splitting clinical care between different providers creates significant barriers to data access. Patients and providers are required to go through lengthy bureaucratic procedures, often manually administered, to gain access to the data. This results in inefficiencies, unfairness, loss of traceability, and medical errors. UPHR solves this fundamental problem of data fragmentation by unifying all the clinical data under one roof with the patient in control.

• Enhanced Data Integrity. Incomplete medical data makes it difficult to assess the patient's journey and reconstruct a full medical history. The gaps in the data create opportunities for medical errors, drug-drug interactions, loss of vaccination records, loss of baseline clinical data, missed allergic reactions, and erroneous diagnostics. Furthermore, clinical or public health research based on incomplete medical data can be either inconclusive or misleading.

• Democratized Access and Standardization. Maintenance of the EHR system life-cycle, including their backend data serving capabilities, is a resource-consuming task. It is also a cause of market fragmentation and variability in standardization and quality. Efforts such as the transformation of electronic medical records into standardized common data models have demonstrated the potential to reduce fragmentation, improve interoperability, and lower barriers for smaller providers and application developers (Lynch et al., 2019). While achieving widespread reliance on the UPHR will require full implementation and acceptance, incremental steps, such as modular integrations and pilot programs, can establish its value and pave the way for broader adoption. By creating a common denominator that reduces the burden of system maintenance, the UPHR has the potential to enable smaller providers and application developers who cannot allocate significant financial and infrastructure resources to create their own systems.

• Strengthened Public Health Response. The COVID-19 public emergency exposed significant gaps in the current system for collecting and analyzing epidemiologic information. Consistently tracking the spread of the pandemic proved to be a complex and highly challenging task. Similarly, identifying the most effective clinical management approaches was hindered by fragmented data systems. The efforts of the Johns Hopkins University Center for Systems Science and Engineering to collect and analyze pandemic data underscored the urgent need for a unified system to enhance monitoring and analytics during future public health crises (Dong et al., 2022). Such a system would provide critical insights and enable more effective responses to emerging health threats.he COVID-19 public emergency clearly demonstrated deficiencies in the current system for collecting epidemiologic information. It proved to be very difficult, or impossible, to consistently track the spread of the pandemic. It was also challenging to see the big picture in terms of which clinical management approaches work better. Indeed, the challenges faced by the Johns Hopkins University Center for Systems Science and Engineering in collecting consistent pandemic data highlighted the need for a unified system to improve monitoring and analytics for future public health emergencies (Dong et al., 2022). A unified system can enable such monitoring and analytics for future cases.

• Better Management of Healthcare Expenditures. Healthcare represents the largest sector of the US economy, yet its return on investment (ROI) remains suboptimal compared to many other developed nations with advanced healthcare systems. Studies have demonstrated that targeted public health interventions in these countries consistently yield higher ROIs, highlighting the potential for significant improvements in efficiency and outcomes within the US healthcare sector (Masters et al., 2017). By centralizing and streamlining data management through the UPHR, healthcare systems can reduce redundancies, improve resource allocation, and better support evidence-based decision-making, ultimately driving more effective use of healthcare expenditures.

• Improved Patient Education and Self-Management. Patient engagement, as a cornerstone of successful prevention and clinical care, is often discussed in various healthcare forums. But what does it mean to truly enable the patient? UPHR is one of the most effective pathways towards patient enablement. Research demonstrates that patient engagement can significantly improve health outcomes and reduce costs, with case studies highlighting the role of transparency, collaboration, and technological innovations in achieving these benefits (Laurance et al., 2014). Studies have shown that information technology significantly enhances patient engagement by enabling better access to health information and fostering behavior change, ultimately improving health outcomes (Sawesi et al., 2016). Building trust and transparency in patient engagement strategies, particularly through clear communication and the ethical use of health information, is vital for fostering meaningful behavior change and reliance on health interventions (Mangal et al., 2022). The integration of AI into patient engagement strategies must prioritize appropriate reliance and trust-building to ensure effective adoption and impact (Benda et al., 2021).

• Encourage Industry Collaboration. UPHR is the backbone of the future health services delivery ecosystem. It opens the space for collaboration and fair competition for the industry participants. It can also serve as a connector between different branches of healthcare including academic and industrial research, provider services, management of financial expenditures and supply chains, lifestyle and behavioral interventions, and so on.

• Accelerated Pharmaceutical and Medical Device Development. Real-world data is one of the most important levers in medical technology research and development. Such data is often available in small cohorts and for narrowly defined demographics. In many cases, especially in rare diseases, access to research data is very limited. Being able to pull the most complete (and standardized) data across the entire population can be a significant enabler of pharmaceutical and medical device research. This is especially true given the quick progress in machine learning and foundation models. While health records are better defined as “small data”, there is a trove of opportunities in the development of various clinical care models.

Conclusion

The path to establishing a unified patient health record is complex but essential for the future of healthcare. By focusing on patient ownership, robust security, global interoperability, and collaborative ecosystems, we can overcome existing barriers and create a healthcare system where patients truly own and control their health data. This whitepaper outlines the foundational steps and considerations necessary for this transformation, emphasizing the importance of legislative support, advanced technology, and international cooperation. Future research and discussions should continue to refine these strategies, ensuring the UPHR becomes a reality that benefits all stakeholders in the healthcare ecosystem.