Personal Health Device Implementation Guide
1.0.0 - STU 1

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## Purpose

The Continua Implementation Guide (IG) describes how information from Continua-certified Personal Health Devices (PHDs) is represented in FHIR. In short, this IG is a sophisticated mapper. PHDs are devices that are mostly used in home-care contexts and include Continua-certified devices such as glucose meters, blood pressure cuffs, weight scales, thermometers, etc. The PHD ‘information’ in this context means both the measurements taken by the PHD and data about the PHD itself. The PHD data includes characteristics, operational status and capabilities for the device, such as the serial number, manufacturer name, and firmware revision. Typically, the PHD is in the patient’s home or on the patient’s person.

In most cases a Continua-certified Personal Health Gateway (PHG) is responsible for receiving and decoding the information from the PHD. Implementations following this IG are likely to be done on PHGs. When a PHG is involved, information about the PHG is also generated.

Patient information, such as demographic and administrative information about the patient, is treated separately. First, patient information is not provided by PHDs through standardized protocols and therefore must be supplied and associated by out-of-band means to a PHG. Second, PHD measurements are typically taken remotely requiring that any patient information be transferred across the public network. For protection of Personal Health Information (PHI) the Continua profile allows PHGs to be supplied with opaque and unique ‘keys’ by out-of-band means that only the health care provider can link to a patient. In addition, there is a more extreme option where a Patient resource is never generated, allowing a PHG to exist with no PHI located anywhere on it. Using these approaches PHI is never exchanged on the wire and furthermore, does not need to be present on the PHD or PHG. That being said, this IG does not require that PHI be protected. Implementations are free to populate any of the other fields of the Patient resource. A common case where PHI is of little concern and even desired is in the handling of fitness data from activity monitors and related fitness devices.

The purpose of this Implementation Guide is to specify the mapping of PHD information to FHIR components. No interpretations of the data or assumptions about what data is important are specified. Implementations following this guide map all viable data provided by the PHDs. The receiver may handle the data as it sees fit for its use case. For example, a consumer may only be interested in the Observation and Patient resources and therefore discards the Device resources. For this reason, there is no use of the must-support criteria made by this IG.

For consumers (readers) of FHIR data, this Implementation Guide specifies the FHIR resources that contain the PHD information and what elements contain what fields. Readers interested in using the FHIR resources specified by this IG can read the Profile Consumers chapter.

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HL7 GitHub location: https://github.com/HL7/phd