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input/pagecontent/Bundle-ContinuaBundleWithDevice-intro.md
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The following example shows a real-life recording of a home monitoring blood pressure measurement. Due to the | ||
size and complexity of this example, a bit of background and guidance on the contents will be provided | ||
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## Background | ||
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In many situations citizens may use personal equipment (their own property or borrowed from a healthcare | ||
provider) to automatically capture and record medical observations. This class of equipment is known by the | ||
term "Personal Health Devices" (PHDs). A number of challenges arise from the complexity of dealing with | ||
diverse consumer-grade Internet-connected equipment used under no clinical supervision: | ||
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- Type, quality, accuracy and provenance of the observations? | ||
- Systematically recording the state of sensors and relevant events detected during the measurement. | ||
- Meta information regarding the equipment, the observation, or the context. | ||
- What is the identity of the patient/citizen/user? Authorization, authentication, etc... | ||
- Accuracy of timestamps, consistency of timelines etc. In particular when the PHD is used by someone | ||
traveling around the globe. | ||
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### Standardization and Interoperability | ||
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In order to deal with these challenges and coordinate the effort across many different standardization bodies, | ||
the [Continua Design Guidelines (CDG)](https://www.pchalliance.org/continua-design-guidelines) has been | ||
created, and the coordination effort continues under the [IHE Personal Connected Health | ||
(PCH)](https://wiki.ihe.net/index.php/Personal_Connected_Health) program. In 2013, Denmark adopted the CDG | ||
as a [reference | ||
architecture](https://sundhedsdatastyrelsen.dk/-/media/sds/filer/rammer-og-retningslinjer/referenceaktitektur-og-it-standarder/referencearkitektur/referencearchitecture-collecting-health-data-citizens.pdf). | ||
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The CDG offers guidance to implementors of PHD equipment and related applications, providing a single data | ||
model that may be expressed and exchanged using (and translated back and forth between) many different | ||
container formats and transports: | ||
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- [IEEE 11073 PHD](http://11073.org/) | ||
- [HL7 FHIR PHD IG](http://hl7.org/fhir/uv/phd/) | ||
- [HL7 CDA PHMR](https://www.hl7.org/implement/standards/product_brief.cfm?product_id=33) | ||
- HL7 v2 Messaging | ||
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With transports ranging from [Bluetooth Low | ||
Energy](https://www.bluetooth.com/bluetooth-resources/personal-health-devices-transcoding/), NFC, USB, | ||
Internet, to [XDS.b and XDR exchange of PHMR | ||
documents](https://www.itu.int/rec/dologin_pub.asp?lang=e&id=T-REC-H.813-201911-I!!PDF-E&type=items) | ||
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## Bundle Overview and Reader's Guide | ||
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The example provided here is the data payload transferred from the home of the user over the Internet to a | ||
central collection server at a tele-monitoring service provider. This bundle is a single self-contained | ||
message, demonstrating how a blood pressure measurement is encoded using a FHIR Bundle compliant to *both* the | ||
[HL7 FHIR PHD IG](http://hl7.org/fhir/uv/phd/) *and* the `DkCoreObservation` profiles. | ||
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### Bundle Structure and Content | ||
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The Bundle contains the following entries: | ||
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- **The Patient** As the bundle must be self-contained, a Patient resource must be included. This is of | ||
course a `DkCorePatient`. | ||
- **The Gateway Device** The blood pressure monitor device used in this case is not aware of the identity of | ||
its user. It will just send the measurement using Bluetooth Low Energy to a compliant gateway. The | ||
gateway - in this case an Android app - is responsible for adding the identity of the patient, and also for | ||
checking (and correcting if necessary) the blood pressure monitor's built-in clock, which is used to create | ||
the observation timestamps. | ||
- **The PHD** In this case, a blood pressure monitor from A&D was used to create a blood pressure | ||
measurement. | ||
- **Battery Level Observation** The A&D blood pressure monitor gauges its own battery every time it is used. | ||
- **Coincident Timestamp Observation** The Gateway Device reads the clock of the PHD and creates this | ||
observation of the *current time* of the PHD timestamped using the Gateway's clock (which is supposed to be | ||
synchronized with a time service). This is a way to detect (and possibly correct) breaches in the timeline. | ||
- **Blood Pressure Observation** This is a `DkCoreObservation` | ||
- **Heart Rate Observation** Also a `DkCoreObservation` | ||
- **Blood Pressure Status Observation** This observation type can be used to report a number of conditions | ||
during the measurement. In this case, an irregular pulse was detected during the measurement. Some PHDs may | ||
be able to report different conditions - e.g. that the blood pressure cuff was too loose. | ||
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You may also notice that the type of the Bundle is a transaction bundle and that all the entries in the | ||
bundle are conditional creates using a funny-looking identifier, which is actually the result of a calculated | ||
function that summarises the resource into a short form (hash), in order to prevent duplicates. | ||
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## Narrative Content | ||
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