Personal Health Device Implementation Guide, published by HL7 International / Devices. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/phd/ and changes regularly. See the Directory of published versions

Change Log

Page standards status: Informative

Highlight text changes?

Major Updates in version 2.0.0 since version 1.1.0

Standards Foundation Updates

1. IEEE 11073-10206 Support: The IG now focuses on comprehensive support for IEEE 11073-10206 ACOM (Abstract Communication Object Model) specifications, moving away from the original IEEE 11073-20601 focus.

2. Bluetooth GHS Integration: Added support for Bluetooth Generic Health Sensor (GHS) specifications, broadening the scope of supported personal health devices.

Documentation and Profile Improvements

1. Enhanced Profile Consumer Documentation: Significantly rewritten consumer guidance with better explanations of how to use PHD-generated FHIR resources, including clearer guidance on measurement types, status handling, and device information.

2. Reorganized Technical Content:

   • Consolidated IEEE 11073 FLOAT/SFLOAT documentation
   • Integrated coincident timestamp content into profile documentation
   • Updated guidance for better clarity

Terminology Updates

1. Code System Migration: Updated to use official HL7 terminology server versions of ASN1ToHL7 and Continua Device Identifiers code systems.

2. Missing MDC Codes: Added support for MDC codes not yet available in standard terminology, including Spirometer device specialization.

Profile Enhancements

1. IEEE 11073-10206 Mapping: Added formal mappings showing how ACOM elements map to FHIR elements in the PhdDeviceMetric profile.

2. Profile Documentation: Enhanced explanations across all profiles with clearer guidance on when elements are used and how they relate to IEEE 11073 standards.

Example Updates

1. Improved Examples: Updated observation examples with better documentation and clarifications about identifier usage in real implementations.

Content Quality Improvements

The changes focus on improving documentation quality, clarifying the relationship between IEEE 11073 standards and FHIR profiles, and ensuring terminology consistency. The updates make the IG more consumable for implementers while expanding support for both IEEE 11073-10206 ACOM and Bluetooth GHS specifications.

Resolved Issues

Issues reported against this IG are tracked in the HL7 Jira system. The following table lists the issues that have been "resolved" and "applied" in this release of the PHD IG:

Key	Summary
FHIR-52861	PhdDeviceMetric should have source as mandatory element
FHIR-52115	please characterize major changes in your change log
FHIR-48397	Ensure appropriate copyright on IEEE codesystems
FHIR-48280	Examples need modification- current stories are repetitive.
FHIR-48244	Streamline PHD IG
FHIR-48243	PhdCompoundNumericObservation
FHIR-48242	PhdCodedEnumerationObservation
FHIR-48241	PhdBitsEnumerationObservation profiling
FHIR-48240	PhdRtsaObservation profiling
FHIR-48239	PhdStringEnumerationObservation profiling
FHIR-48238	Profiled resources can reference non-profiled resources
FHIR-48237	PhdCoincidentTimeStampObservation profiling
FHIR-48236	Review and correct PhdDevice and PhgDevice profiling
FHIR-48234	DeviceTypes11073MDC should be intensionally defined.
FHIR-48233	Valueset incorrectly claims to have exactly 1000 concepts
FHIR-48232	ASN1ToHL7 Codesystem cleanup
FHIR-48231	ContinuaPHD Codesystem cleanup
FHIR-48230	Remove non-existant code hierarchies
FHIR-48229	Correct CapabilityStatement kind
FHIR-48228	Remove unused CodeSystem ASN1EventOrState
FHIR-48227	Revert gratuitous change to R4B
FHIR-48226	Correct MDCnotObject VS definition
FHIR-48225	Fix Numeric Observation profile
FHIR-48224	PhdPatient is overly constrained.
FHIR-48223	Inconsistent use of ® mark
FHIR-48222	Remove box around "threshold error"
FHIR-48221	Complete IG needs proofreading
FHIR-48220	Clarify GHS and Source-handle-reference
FHIR-48219	Clarify current timeline.
FHIR-48218	Correct "current" misspelling
FHIR-48217	Assorted performer corrections
FHIR-48216	Section duplicates content.
FHIR-48215	Assorted BaseObservation profile recommendations
FHIR-48214	Slicing for identifier is incorrect.
FHIR-48213	Profiling should contain mappings
FHIR-48212	BaseObservation require presence of unused meta
FHIR-48211	Clarify accuracy units
FHIR-48210	Clarify conditional create identifier generation.
FHIR-48209	Include discussion of additional PHG behavior
FHIR-48208	Missing word
FHIR-48207	Correct spelling of Artifacts
FHIR-48206	Assorted issues with Patient resource discussion
FHIR-48205	Use boolean rather than coded Y/N
FHIR-48203	USB PID/VID are not identifiers
FHIR-48202	Document device identifier formats
FHIR-48201	Clean up UDI language
FHIR-48200	Review coincident timestamp for use in sometimes-connected environments
FHIR-48199	Correct "timeline"
FHIR-48198	PHDs may support external time sync
FHIR-48197	ReferenceRange not for recording min/max values
FHIR-48196	Correct spelling of "indicating"
FHIR-48195	Should populate coding.display.
FHIR-48194	Choosing components vs separate Observations.
FHIR-48193	dataAbsentReason misspelled
FHIR-48192	PHD IG is unnecessarily large
FHIR-48191	"Two other values" should be enumerated
FHIR-48190	Correct numbering of section 1.2.4.1
FHIR-48189	Do not expect clients to ignore identifiers
FHIR-48188	Quantity can record "off-scale" values
FHIR-48187	Text ascribes actions to the IG itself
FHIR-48186	Assorted spelling errors
FHIR-48185	Clarify drivers of relative timestamp adoption
FHIR-48183	Clarify referenced specification and tick resolution
FHIR-48182	Much simpler needs a comparison
FHIR-48181	V2 Binary needs codesystem
FHIR-48180	Correct spelling of valueCodeableConcept
FHIR-48179	Use of derivedFrom is incorrect
FHIR-48178	Coincident timestamp inconsistent with FHIR expectations
FHIR-48177	Reasons for disallowing Instant datatype do not make sense
FHIR-48176	Clarify effective[x] can be two datatypes
FHIR-48174	Do not link to build.fhir.org.
FHIR-48173	Do not require ignoring identifier
FHIR-48172	Technique should be in method not component
FHIR-48171	Don't use derivedFrom for coincident time stamp
FHIR-48170	Clarify extension description
FHIR-48169	Use coding style for elements and resource content
FHIR-48168	Correct description of profile element
FHIR-48167	Clarify non-processing of string measurements
FHIR-48166	Justify state or event measurement profile
FHIR-48165	Do not require profile declarations
FHIR-48164	Clarify use of "text" entries
FHIR-48163	Timestamp is one word
FHIR-48162	Simplify Coincident timestamp mention.
FHIR-48161	Add missing hyphens
FHIR-48160	Clarify use of manually entered data
FHIR-48159	Clarify protection of PHI
FHIR-48158	Correct physical state
FHIR-48157	Clarify diabetes use case
FHIR-48156	Clarify multiple RPM scope bullets
FHIR-48155	Clarify whether asserted statements are general or part of a use case.
FHIR-48154	Confirm most PHDs used for RPM.
FHIR-48153	Remove unnecessary capitalization
FHIR-48152	Define "communicating PHD"
FHIR-48151	Glossary or list of organizations would be helpful
FHIR-48150	Add link to IHE
FHIR-48149	Clarify point of reference to Continua guidelines
FHIR-48148	Add link to H.812.5
FHIR-48147	Justify 95% reference
FHIR-48146	Clarify audience introductory sentence.
FHIR-48145	Github link broken
FHIR-48144	Clarify mapping of all data by PHG
FHIR-48143	FHIR components is not clear
FHIR-48142	Ensure protection of PII.
FHIR-48141	Clarify patient information
FHIR-48140	Clarify ACOM
FHIR-48139	Remove Continua references
FHIR-48138	Purpose is (almost) duplicative of Home page.
FHIR-48137	Correct section numbering.
FHIR-48136	State Profile Consumer section more positively for audience.
FHIR-48135	Remove history and FHIR overview sections
FHIR-48134	Overview page is largely redundant
FHIR-48133	IG Menu should be more complete
FHIR-48132	Include Appendix in menu
FHIR-48131	Remove gratuitious links at bottom of page.
FHIR-48130	Provide links to IEEE 11073
FHIR-48129	Clarify mentions of Bluetooth LE
FHIR-48128	Combine paragraphs
FHIR-48127	Link to referenced sections
FHIR-48126	IGs cannot interpret.
FHIR-48125	IG should be plural.
FHIR-48124	Consistent formatting for IEEE standard names
FHIR-48123	Link to published PoCD guide
FHIR-48122	Clarify whether IG scope is beyond quality and research
FHIR-48121	Call out box incorrectly flags IG as CI build
FHIR-48020	I would remove the italics and bold on this page
FHIR-48018	References to the IEEE specs and Bluetooth would be useful
FHIR-48017	Inconsistent references to ACOM spec
FHIR-48015	Typo - " Abstract COntent Model"
FHIR-48013	Second paragraph - "Implementations following this IG are likely to be done on PHGs." - what does this mean?
FHIR-48012	Suggestion for home page diagram
FHIR-48011	What is " a PHG-validated consistent time stamp"?
FHIR-48010	Confusing text about -20601
FHIR-48008	Reference missing for "The Technical Implementation Guidance section …" and "The Profiles section"
FHIR-48006	Looks like random words are with italic style
FHIR-48005	References to the IEEE specs would be useful
FHIR-48001	"Uploads generated by compliant PHGs.." - what are compliant PHGs?
FHIR-47657	Need further alignment with latest IEEE ACOM specification
FHIR-47609	Consider support for UDI in PHD
FHIR-47576	PHG Implementation Guidance page should have PHG spelled out
FHIR-47575	Plain Language Summary about HL7 and this Guide to the Home Page.
FHIR-47574	Continuous Build note (in salmon) should be removed
FHIR-47493	Data element provenance seems to be missing
FHIR-46964	Link to / use of "Continua"
FHIR-46832	Minor typos
FHIR-46831	Reduce the ties to 20601
FHIR-46830	Duplicated contents
FHIR-46829	Wrong MDC code (5)
FHIR-46828	Non-context-free MDC codes
FHIR-46823	Dead link to RTMMS
FHIR-46822	Dead link to LOINC
FHIR-46821	Wrong MDC code (4)
FHIR-46820	Wrong MDC code (3)
FHIR-46819	Wrong MDC code (2)
FHIR-46818	Wrong MDC code
FHIR-46768	remove "Fixme"
FHIR-46767	Meta.profile mandatory or not?
FHIR-46766	LOINC "magic" codes (still)
FHIR-46765	Esoteric language
FHIR-46764	Conditional-create identifier
FHIR-46586	derivedFrom pointing to a coincident timestamp conflicts with vital signs constraints