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CloudCare by Diabeter

By Medtronic Belgium

CloudCare is a device agnostic, remote population management solution that enables clinics to transform their care for diabetes patients.

Level 2

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

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General description
Additional info
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General description (provided by company)

Main purpose

CloudCare allows clinics to enable their transformation of care delivery. Increasing outcomes and experiences of its population and drive clinic efficiencies. From a physician/nurse perspective you are now real time in better control of the health status of your patient. CloudCare allows you to focus on the patient which benefits from your medical expertise at the moment they need it. When integrated into your clinical workflows CloudCare identifies patients benefiting from a remote consult or which require an urgent in person visit. On the other hand, CloudCare also identifies the patients which are doing well. Here you can choose to change existing planned in person visits to remote visits or potentially cancel them if patient condition is excellent. CloudCare allows you to initiate hybrid and patient centric care pathways. Increasing clinical efficiencies, patient outcomes and patient experiences.

Target audience

CloudCare is designed for the purpose of HealthCare Population Management of Insulin-Dependent Patients who use a Blood Glucose Meter (BGM), Flash Glucose Monitoring (FGM), or Continuous Glucose Monitoring (CGM) or a Pump by the Patients Care team. The patients enrolled by the Care team in CloudCare have access to the CloudCare patient app where they can see their real-time device uploads to monitor their self-condition. So, the solution contains both a care team application/platform and a patient app facilitating efficient (remote) consultations and patient empowerment.

Approach

CloudCare enables HCPS to provide care to the right patient at the right time at the right place. From a patient perspective this means that when real-time data shows that a patient can benefit from therapy-related advice the HCP could schedule a remote consultation also leveraging the patient heatmap in the app. When patient conditions deteriorate fast, the HCP can initiate an in-person visit to the clinic to prevent acute admission. Ultimately when a patient is doing well, existing follow-up visits can be scheduled to remote or even cancelled when this is allowed.

Connectivity to sensors and platforms

The system is connected to any BGM, CGM, FGM or Pump manufacturer as long as data is uploaded by the device(s). CloudCare has built in, import and export capabilities to connect to hospital Electronic Health Records (HER) or other platforms.

Financing and pricing model

Financing and pricing still to be determined

Pathology

Diabetes

Functions

Alerts & Notifications Data Sharing Diagnostics Health Tracking Remote Clinical Monitoring Treatment Support

Users

Everyone

Additional info

This app temporarily, until October 1, 2024, still carries the old M2 label because the requested ICT criteria were met. For now, no reimbursement request has been submitted for this app so it would no longer fall under level M2 in the new model.

Compliance to M2 criteria

Reimbursement request

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 Medtronic (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)
Certificate granted on 17/05/2021 Certificate valid till 25/05/2024 Class type of medical device (More info): Class I
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: 00355 Product identification code at FAMHP: 836784

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

User instructions

Using the regular device data uploads from your BGM, FGM, CGM or pump manufacturer, CloudCare algorithms calculate a for each patient in your clinical a standard set of metrics and produces the so-called Glucose Heatmap. The heatmap is immediately available in the patient app so he or she can view in a very friendly way the daily glucose levels. This processed data is combined with patient specific clinical data (e.g., age, gender, weight, height, therapy, risk factors, comorbidities etc.) which is now ready for CloudCare Triage service. This service, leveraging an agreed triage protocol, will label the patient upload with a “green, amber or red traffic light result”. The triage results trigger configured notifications to the care team which will be picked up by the clinic workflows driving clinic procedures.

Components of the application

Native appWeb applicationMedical device

Complaints handling

Via e-mail: rick.paauw@medtronic.comVia telephone: +31 6 20 04 06 14

Media

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