description: This profile defines a Personal Health Device within the context of § 374a SGB V. A Personal Health Device acc. to this profile is any\nmedical aid or implant that \n- is distributed to patients at the expense of the statutory health insurance and \n- transmits the data about the patient electronically to the device manufacturer or third parties, which make the data available to patients and/or physicians via publicly accessible networks. \n\nPersonal Health Devices that fulfill the criteria of this regulation MUST be able to pass on data to authorized Digital Health Applications (DiGA acc. § 374a SGB V) using the protocols \nand interfaces as defined in the HDDT specification.\n\nThis profile helps a device data consuming DiGA to\n- increase patient safety by comparing the serial number of a Personal Health Device as presented with this profile with the serial number the patient may have provided to the DiGA\n- increase data quality by getting information about the current status of the end-to-end communication flow from the Personal Health Device to the device backend and thus being able to detect if there may be more data available for the requested period\n- optimize its interactions with the device data providing resource server by getting access to the DeviceDefinition resource that holds static attributes about the device and its connected backend (e.g. minimum delay between data measurement and data availability)\n\n**Obligations and Conventions:**\n\nThe Personal Health Device's backend regularely synchronizes with the device hardware through a gateway (_Personal Health Gateway_). \nThe maximum delay that the concrete end-to-end synchronization from the Personal Health Device to the FHIR resource server imposes is provided by the BfArM _HIIS-VZ_ (Device Registry) per MIV\nthrough the static attribute `Delay-From-Real-Time`. If a resource server has not synchronized with the connected Personal Health Device for a time span \nlonger than `Delay-From-Real-Time`(e.g. due to temporarely lost Bluetooth or internet connectivity), the `status` of the Device resource that represents the \nPersonal Health Device MUST be set to `unknown`.\n\n**Constraints applied:**  \n- `status` is set to _Must Support_ in order to allow a DiGA to detect missing data (e.g. due to connection issues)\n- `deviceName` and `serialNumber` are set to _Must Support_ to allow a validation of the source of device data by comparing this information with information printed on the Personal Health Device\n- `definition` is optional. If present it MUST refer to a DeviceDefinition resource in the BfARM HIIS VZ. This ensures that DiGA can only receive static product information which was registered by the vendor of the device.\n- `expirationDate` is set to _Must Support_ to allow a DiGA to be aware of regular sensor changes (e.g. for patient wearing a rtCGM)
package_name: de.gematik.hddt
derivation: constraint
name: HddtPersonalHealthDevice
type: Device
elements:
  definition: {short: Definition of the Personal health device, index: 0}
  status: {mustSupport: true, index: 1}
  expirationDate: {short: Date and time of expiry of this Personal health device (if applicable), mustSupport: true, index: 2}
  serialNumber: {short: Serial number of the Personal health device, mustSupport: true, index: 3}
  deviceName: {short: Name of the Personal health device, mustSupport: true, index: 4}
  type:
    short: The machine-readable type of the Personal health device
    binding: {strength: required, valueSet: 'https://gematik.de/fhir/hddt/ValueSet/hddt-device-type'}
    index: 5
package_version: 1.0.1
class: profile
kind: resource
url: https://gematik.de/fhir/hddt/StructureDefinition/hddt-personal-health-device
base: http://hl7.org/fhir/StructureDefinition/Device
version: 1.0.1