CardioCare@Home

By Byteflies

CardioCare@Home is a prescription digital health service for patients with a medical indication for long-term cardiac monitoring at home.

Level 2

I submitted a reimbursement request to NIHDI, which is eligible.

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General description (provided by company)

Main purpose

CardioCare@Home is a prescription digital health service for patients with a medical indication for long-term cardiac monitoring at home. Cardiac information is collected with a comfortable wearable device (CardioCare Patch) and transmitted to a healthcare provider via the CardioCare@Home Pro application to help them make an informed decision.

Target audience

Healthcare providers who care for patients who are indicated for cardiac monitoring at home.

Approach

The CardioCare Patch collects electrocardiogram (ECG) and inertial (motion) data. This data is transmitted to the CardioCare@Home Pro at regular intervals. Once uploaded, the sensor data is analyzed to derive heart rhythm and physical activity information. That information, together with the sensor data, is made available for the healthcare provider in the CardioCare@Home Pro for further review and analysis.

Connectivity to sensors and platforms

CardioCare@Home Pro interfaces with Byteflies Kit and Byteflies ECG Adhesives (CardioCare Patch). These wearable medical devices are designated for the long-term monitoring of physiological and behavioral signals, which are both assessed in CardioCare@Home Pro.

Financing and pricing model

CardioCare@Home is a prescription subscription service that may be covered by your healthcare provider or insurance. The service fee includes use of the wearable device, data transmission and analysis, user training, and technical support. If you are a healthcare provider interested in using CardioCare@Home, please contact us at hello@cardiocareathome.com.

Pathology

Heart / Blood Vessels

Functions

Diagnostics Remote Clinical Monitoring Treatment Support

Users

Teen Men Women Elderly Clinicians

Additional info

Compliance to M2 criteria

Reimbursement request

Submission date

17-12-2022

Evaluation date

06-02-2023

Evaluation result

Negative Positive

Self declaration to 6 ICT criteria

Criterion 1: GDPR app category

1 (no processing of personal data) 2 (processing of personal data) 3 (processing of sensitive personal data)

Criterion 2: Identification of the user in need of care

through his/her Social Security Identification Number (SSIN) (obliged for applications of GDPR app category 2 or 3, see above) other

Criterion 3: App user authentication

not applicable (only for app category 1) via FAS level 400 (FAS = Federal Authentication Service, More info) company own authentication system fulfilling the M2 requirements (self-declared)

Criterion 4: Verification of therapeutic relationship and informed consent

not applicable via eHealth platform user and access management system IAM (More info) via company own database fulfilling the M2 requirements (self-declared)

Criterion 5: Applied interoperability standards

KMEHR (More info) HL7 CDA (More info) HL7 FHIR (More info) SNOMED-CT (More info) Other

Criterion 6: GDPR compliance

comply with the principles of (stated in article 5 of the GDPR)
  • lawfulness, fairness and transparency
  • purpose limitation
  • data minimisation
  • accuracy
  • storage limitation
  • integrity and confidentiality
 honour the rights of the data subject (as mentioned in Chapter III of GDPR) comply with the special provision on the processing of sensitive personal data (obliged for applications of GDPR app category 3, see above) carried out a data protection impact assessment (according to articles 35 and 36 of GDPR)

Extra: Secured Messaging

not applicable via eHealth platform’s eHealth Box (More info)

Compliance to M1 criteria

CE certification

Download document Granted by Self Declaration Assessed and certified meeting the requirements of:
Medical Device Directive: MDD 93/42/EEC (old regulation) Medical Device Regulation: MDR 2017/745 (new regulation) In Vitro Diagnostic Directive: 98/79/EC (old regulation) In Vitro Diagnostic Regulation: IVDR 2017/746 (new regulation)
Certificate granted on 23/08/2021 Certificate valid till 31/12/2028 Class type of medical device (More info): 1
ISO Standards:
ISO 13485 Quality Management Systems for Medical Devices (on company level) ISO 14155 Clinical Investigations of Medical Devices in Human Subjects ISO 14971 Risk Management of Medical Devices ISO 27000 series: Information Security Management Systems ISO 62304 Medical Device Software Lifecycle Processes ISO 62366 Application of Usability Engineering to Medical Devices

FAMHP registration and notification

Company registration number at FAMHP: 73250 Product identification code at FAMHP: 644394

General Data Protection Regulation (More info)

Company declares explicitly to be compliant with GDPR rules Company declares that the data are stored in EU only

The app is only available through prescription

Reference publication

Byteflies is ISO 13485 certified for the design and production of medical devices (hardware and software) and has cleared medical products on the market in the EU and US. All Byteflies Care@Home applications are developed in close collaboration with clinical and patient stakeholders. Example of use in clinical research: https://www.medrxiv.org/content/10.1101/2020.07.27.20151589v1

User instructions

The patient will learn how to use the CardioCare Patch during a consultation with their healthcare provider. They will also receive instructions on how to install a mobile app on their personal device that will assist them in using the CardioCare Patch at home.

The healthcare provider will have access to the CardioCare@Home Pro hospital application to manage active patients, and review and score the collected data. More information about CardioCare@Home Pro can be found here: https://ifu.byteflies.net/docs/hcp/cardiocare.html

More information about the Byteflies Kit, the wearable medical device used to collect the data, can be found here: https://ifu.byteflies.net/docs/hcp/kit.html

Components of the application

Web applicationClient-server

Complaints handling

Via e-mail: hello@cardiocareathome.comVia telephone: +32 32 94 74 99

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