HL7 Personal Health Record System Functional Model, Release 2
2.0.1-ballot - Normative Ballot

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## Introduction

### Notes to Readers

The HL7 Personal Health Record System Functional Model (PHR-S FM) was approved as a Draft Standard for Trial Use (DSTU) in July 2008. In September 2010 the PHR-S FM was presented to ISO TC215 as a New Work Item Proposal (NWIP) ballot and received comments from the international community. The comments from that ballot were used to update and improve the draft standard. In September 2013, the standard was updated, re-balloted, and the comments reconciled – resulting in the current version.

### Changes from Previous Release

This personal health –focused standard (PHR-S FM) was developed in harmony with the clinically-focused HL7 EHR System Functional Model (EHR-S FM). When the EHR-S FM’s layout was enhanced from Release 1 format to Release 2 format, the HL7 Personal Health Record Work Group determined to update and harmonize the PHR-S FM from Release 1 format to Release 2 format as well. The PHR-S FM will follow the format of the EHR-S FM with respect to the replacement of the Information Infrastructure Section with two individual sections: the Records Infrastructure section and the Trust Infrastructure section.

### Background

#### Personal Health Record (PHR) Versus a Personal Health Record System (PHR-S)

The PHR WG makes a clear distinction between a PHR and a PHR System (PHR-S). The PHR is the underlying record (e.g., data, information, pictures, sounds, graphs, or videos) that the software functionality of a PHR-S maintains. There has been much discussion surrounding the definition of a personal health record. The PHR-S FM does not attempt to define the PHR, but rather to identify system features and functions necessary to create and effectively manage PHRs. The PHR-S FM offers examples of data elements, but is not intended to provide details necessary to specify a data model. The overarching theme of a PHR-S involves a patient-centric tool that is controlled, for the most part, by the individual PHR Account Holder. A PHR-S should be immediately available electronically and able to link to other systems. The PHR-S provides functionality to help an individual maintain a longitudinal view of his or her health history, and may be comprised of information from a number of sources – e.g., from providers and health plans, as well as from the individual. Data collected by the system is administrative and/or clinical, and the tool may provide access to health-related forms (e.g., Advance Directives) and advice (e.g., diet, exercise, or disease management). A PHR-S might also help the individual collect behavioral health, public health, patient-entered and patient-accessed data (including medical monitoring devices), medication information, care management plans and the like, and might be connected to providers, laboratories, pharmacies, nursing homes, hospitals and other institutions and clinical resources. This PHRS-FM is universal and therefore generic by design. There may be additional constraints in certain realms or regions. For example, in the US Realm, the management of laboratory results is subject to the Clinical Laboratory Improvement Amendments (CLIA) federal regulation. At its core, the PHR-S should provide the ability for the individual to capture and maintain demographic, insurance coverage, and provider information. It should also provide the ability to capture health history in the form of a health summary, problems, conditions, symptoms, allergies, medications, laboratory and other test results, immunizations and encounters. Additionally, personal care planning features such as Advance Directives and care plans should be available. The system must be secure and have appropriate identity and access management capabilities, and must use standard nomenclature, coding and data exchange standards for consistency and interoperability. A host of optional features have been addressed over the course of this initiative, including secure messaging, graphical presentation of test results, patient education, guideline-based reminders, appointment scheduling and reminders, drug-drug interactions, formulary management, health care cost comparisons, document storage and clinical trial eligibility. The effective use of a PHR-S is a key point for improving healthcare in terms of effective self-management, patient-provider communication and quality objectives.

#### Designation of Sections

The PHR-S FM (i.e., all chapters) contains normative, informative, and reference sections. In the conformance clause chapter, the normative content defines how a functional profile achieves conformance to the PHR-S FM.