Update from HL7 mHealth WG

Update on Mobile Health• Overview of Activities• Update on FHIR Resources• Health Care Devices and Mobile Health

Shared Use Cases (Health Care Device & Mobile Device)• ECG Holter Monitor• Glucose Meter

Shared Use Cases (Health Care Device & Mobile Device)

• ECG Holter Monitor

• Glucose Meter

• Blood Pressure/Activity Monitor

Overview of mHealth Activities

• LMIC Subgroup – Service Framework PSS• Security Subgroup – Mobile Security FAQ • Education and Communication – Newsletter,

Articles and Tutorials• Standards Gap Analysis Subgroup – PHR Gap

Analysis • Scenarios and Use Case Subgroup• Mobile Health Fridays 11 am EST

Health Care Devices and Mobile Health

• Mobile devices (smart phones & tablets) can compliment the use of health care devices.

• Mobile devices can facilitate information exchange from home or remote locations.

• Mobile devices can aid the patient in journaling activities while HCD record data.

• Mobile device can assist patient in achieving goals in their personal care plan.

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FHIR Administrative• Attribution

– Patient– RelatedPerson– Practitioner– Organization

• Resources– Device– Location– Substance– Group

• Workflow Management– Encounter– Alert– Supply– Order– OrderResponse

• Financial– Coverage

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FHIR Clinical• General

– AdverseReaction– AllergyIntolerance– CarePlan– FamilyHistory– Condition– Procedure– Questionaire

• Medications– Medication– MedicationPrescription– MedicationAdministration– MedicationDispense– MedicationStatement– Immunization– ImmunizationProfile

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FHIR Clinical - continued• Diagnostic

– Observation– DiagnosticReport– DiagnosticOrder– ImagingStudy– Specimen

• Device Interaction– DeviceCapabilities– DeviceLog– DeviceObservation

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FHIR Infrastructure• Support

– List– Media– Other– DocumentReference– (Binary)

• Audit– Provenance– SecurityEvent

• Exchange– Document– Message– OperationOutcome– Query

• Conformance– Conformance– ValueSet– Profile

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Shared Use Cases (Health Care Device & Mobile Device)

• Patient Use Cases• Care Provider Use Cases• Shared Use Cases (Health Care Device &

Mobile Device)• Public Health use cases: • Low to Middle Income Countries use cases:

Patient Use Cases• Review and schedule my health care appointments.

• Review my labs.

• Renew my prescriptions.

• Ask a care provider a health question.

• Review my health problems, medications, allergies, vaccinations and past medical history.

• Record my blood pressure, weight and glucose readings (mobile device integration).

• Update my family history of illnesses.

Care Provider Use Cases• Review lab results for a patient.

• Review transition of care summary.

• Review notes, reports and care plans for a patient. • Review patient health problems, medications, and allergies.

• Review patient vaccinations and past medical history.

• Check vitals for patient.

• Check for pending lab results.

• Review patient family history.

• Check the patient census for a care unit, are there beds available? • Check my patient list, vitals stable, patient is crashing?

• Review my patient alerts (difficult airway, suspected abuse, chemotherapy patient).

Shared Use Cases (Health Care Device & Mobile Device)

• ECG Holter Monitor• Glucose Meter

Holter Monitor Test• Patient is due for Holter test in preparation for annual

checkup.• Patient elects to have remote Holter test from their

patient portal.• Patient receives Holter Monitor at home mail.• Patient reviews video on how to setup Holter test

monitor.• Patient is instructed to install Holter application on

their smart phone.• Patient applies Holter monitor device and sync device

with mobile device.13

Holter Monitor Test - continued

• Mobile device verifies that Holter Monitor is active and properly setup.

• Patient is given confirmation status ready.• Patient has been instructed to journal

activities while Holter monitor is active.• Patient accidently disconnect lead.• Patient reconnects lead and journals event

and verifies Holter monitor is back to ready.

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Holter Monitor Test - continued

• After 24 hours of monitoring, mobile device indicates test completed.

• Mobile device indicates that test data is ready to upload to patient portal.

• Patient verifies upload to proceed and receives confirmation upon completion.

• Patient returns Holter monitor via mail.

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Glucose Monitor

• Patient is newly diagnosed with diabetes.• Patient has gone through a diabetes education

program and has chosen to use mobile diabetes application to assist in behavioral changes, journaling diet and activities.

• Glucose meter is paired to mobile device to facilitate exchange of data and journal with patient portal.

• Patient records glucose data, eating habits but has questions about how they are doing?

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Glucose Monitor - continued

• Patient accesses their patient portal and seeks feedback from their care team.

• Care team request user to upload diabetes meter and journal data from mobile device.

• Care team reviews data and suggest changes to medication regiment.

• Mobile device can use alerts or reminders to better manage their medication and behavior.

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Glucose Monitor - continued

• Patient learns through many iterations how to manage their diabetes effectively.

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TAN-Interface

WAN

-Interface

LAN-Interface

PAN-Interface

HRN-Interface

Application Hosting Device

LAN Device

Scope

PAN Device

WAN DeviceHRN

Device

PAN DeviceTAN Device

Interface Teams define Certified Device Classes within constraints set by E2E Architecture, then select standards and create guidelines for these Certified Device ClassesE2E Architecture Team

Services Team: Focus on WAN and HRN IFs

Devices Team: Focus on PAN and LAN and TAN IFs

The IEEE 11073 Personal Health Device standards family

• Framework

• IEEE Std 11073-20601 - Application profile - Optimized exchange protocol• IEEE Std 11073-20601a - Application profile - Optimized exchange protocol (amendment)

• and a number of "device specialization" standards - the following exist at present:

• IEEE Std 11073-10404 - Device specialization - Pulse Oximeter• IEEE Std 11073-10407 - Device specialization - Blood Pressure Monitor• IEEE Std 11073-10408 - Device specialization - Thermometer• IEEE Std 11073-10415 - Device specialization - Weighing Scale• IEEE Std 11073-10417 - Device specialization - Glucose Meter• IEEE Std 11073-10420 - Device specialization - Body composition analyzer• IEEE Std 11073-10421 - Device specialization - Peak flow• IEEE Std 11073-10441 - Device specialization - Cardiovascular fitness and activity monitor• IEEE Std 11073-10442 - Device specialization - Strength fitness equipment• IEEE Std 11073-10471 - Device specialization - Independent living activity hub• IEEE Std 11073-10472 - Device specialization - Medication monitor

The IEEE 11073 Personal Health Device standards family ( Continued )

• Device specialization standards

• IEEE P11073-10406 - Device specialization - Basic ECG (1 to 3-lead)• IEEE P11073-10413 - Device specialization - Respiration rate monitor• IEEE P11073-10418 - Device specialization - INR (blood coagulation)• IEEE P11073-10419 - Device specialization - Insulin pump

• Revisions to existing standards:

• IEEE Std 11073-10404 - Device specialization - Pulse Oximeter (revision)• IEEE Std 11073-10417 - Device specialization - Glucose Meter (revision)• IEEE Std 11073-10441 - Device specialization - Cardiovascular fitness and activity

monitor (revision to add 3D accelerometer / physical activity monitor data)

Mobile Medical Apps Final Rule

• The FDA is focusing its oversight on mobile medical apps that: – are intended to be used as an accessory to a regulated medical

device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or

– transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.