Remecare

By Remecare BV

Remecare provides care pathway management and remote patient monitoring to support health care professionals in understanding the patient’s experience beyond the hospital walls. Reported data guides care decisions more efficiently to improve patient’s quality of life and outcomes.

Level 3 plus

I am a CE-certified medical device
I am safely connected
I have proven my social-economic evidence and get reimbursed by NIHDI

Downloads

Download for IOS
Download for Android

Languages

EN FR NL
Visit website
Contact company
General description
Additional info
Media
Financing

General description (provided by company)

Main purpose

Remecare enables health care professionals to understand the full patient experience and to make data-driven decisions so that patients always receive the best possible care. Through Remecare, patients are followed up remotely between hospital visits to ensure continuity of care.

Through a mobile application, patients can report their medication intake, vital signs, symptoms and side-effects every day. Based on these self-reported outcomes, the health care team can provide the patient with suitable advice or request a hospital visit if needed.

Target audience

Remecare facilitates remote patient monitoring along any type of digital care pathway.

Remecare allows health care professionals to be more productive and provide higher quality treatments to patients. All health care professionals (clinicians, surgeons, therapists, general practitioners, dieticians, nurses, …) can connect to Remecare and monitor patients through a personal and secured account. Remecare is available in Dutch, French and English.

Approach

The Remecare app can be used on any smartphone.

Patients can register medication intake, vital signs, symptoms and medication side-effects. The healthcare team is automatically notified in case of deviating values. Patients can start using the Remecare app at any stage of their treatment.

Healthcare practitioners receive live insights into the patient’s treatment journey through the online platform.

Connectivity to sensors and platforms

Interoperable with hospital information systems, Belgian eHealthPlatform and Belgian health hubs.

Certified connectivity with other medical devices, such as weight scales and blood pressure monitors.

Financing and pricing model

Upon prescription by a physician

Pathology

Cancer Heart / Blood Vessels

Functions

Alerts & Notifications Data Sharing Remote Clinical Monitoring Treatment Support

Users

Everyone

Additional info

Compliance to M3 criteria

This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:

Telemonitoring and therapy guidance in chronic heart failure ( More info: NL, FR )

Compliance to M2 criteria

Reimbursement request

Submission date

13-04-2021

Evaluation date

18-10-2021

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 KiWa Dare 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 04/05/2018 Certificate valid till 31/12/2028 Class type of medical device (More info): 2A
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: 73275 Product identification code at FAMHP: 648261

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

Rasschaert M, Vulsteke C, De Keersmaeker S, et al. AMTRA: a multicentered experience of a web-based monitoring and tailored toxicity management system for cancer patients [published online ahead of print, 2020 Jun 9]. Support Care Cancer. 2020;10.1007/s00520-020-05550-6. doi:10.1007/s00520-020-05550-6

User instructions

The Remecare mobile app guides patients through their home therapy, showing them their daily diary, reminding them of their medication and allowing them to register a wide range of vital signs, symptoms and medication side-effects. This allows healthcare professionals to quickly respond to changes in their health situation.

Components of the application

Native appWeb applicationClient-server

Complaints handling

Via e-mail: info@remecare.euVia telephone: +32 3 361 47 26

Media

Screenshot6 Screenshot2 Screenshot3

Financing

This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:

Telemonitoring and therapy guidance in chronic heart failure ( More info: NL, FR )