Haemoassist Register No. EP-S-5XTR8J

Recertification: 08/2022

StatConsult, Gesellschaft für klinische und Versorgungsforschung mbH, proved that its IT-based service Haemoassist® 2 complies with EU data protection law. Haemoassist® 2 is a smart-phone based therapy management application for haemophilia patients and their physicians. It consists of an electronic patient diary (application) in interaction with a web based monitoring-interface for the attending physicians. Patients may not only use Haemoassist via the smartphone app, but also via a dedicated web interface. Patients and their physicians can be sure that processing of personal data –based on patient’s freely given declaration of consent – is in line with the demanding provisions of EU data protection law.

Product/Version

Haemoassist^® 2 (v2.7)

Function as provided in August 2022

Qualification: IT-based service (processor service)

View the Haemoassist^® 2 Certificate

Cert. No.

EP-S-5XTR8J

Gültigkeit

11/08/2022 – 31/08/2024

Recertification No. 2 on 26/04/2019

Recertification No. 1 on 12/08/2016

Initial Certification: 08/10/2014

Monitoring

04/2023

12/2023

Public report

Recertification 2022: Haemoassist^® 2 Short Public Report [PDF]

Recertification 2019: Haemoassist^® 2 (v2.7) Short Public Report [PDF] 

Recertification 2016: Haemoassist^® 2 (v2.4) Short Public Report [PDF] 

Initial Certification: Haemoassist^® 2 Short Public Report [PDF] 

Manufacturer/Provider

StatConsult
Gesellschaft für klinische und Versorgungsforschung mbH
Halberstädter Straße 40a
39112 Magdeburg
Deutschland

BEST

The Haemoassist^® 2 IT-based service uses only pseudonymised data: Instead of the patient´s name, a specific ID is stored in the database of the service. The correlation of the patient´s name to this ID is only known to the patient and his/her physician.

ATTENTION:

Patients and physicians should pay special attention to privacy related issues of their IT systems (smart-phones, clients, etc.), as these items do not form part of the ToE.

Summary

The Haemoassist^® 2 service compiles and stores data from patients and physicians that concerns the type of therapy and the development of the medical condition. This data is stored on the patients’ smartphones and in the central database. Instead of the patient´s name, a specific ID is stored in the database of the service.

Details

Recert 2022/08

In addition to the functionalities that were already covered by the previous recertification, the target of evaluation of the current recertification includes the following (new) functionality:

• Pharmacy module
• Messenger

The re-evaluation showed that Haemoassist 2 meets all applicable EuroPriSe requirements. Further information can be found in the short public report that is available here:

Recert 2019/04

In addition to the functionalities that were already covered by the previous recertification, the target of evaluation of the current recertification includes the following (new) functionalities:

• Comment functionality
• Package tracking (medication)

The re-evaluation showed that Haemoassist 2 (v2.7) meets all applicable EuroPriSe requirements. Further information can be found in the short public report that is available here:

Recert 2016/08

A new technical functionality was implemented for patients: They can now access the IT based-service not only via the already known smartphone app, but also via a new web interface which is secured by login + password and TANs. The (re-)evaluation of the EuroPriSe Experts concluded that this web interface as well as all other relevant components of Haemoassist® 2 (still) meet all applicable legal and technical EuroPriSe requirements (for details, please cf. the current version of the Short Public Report).

Initial Cert

Haemoassist^® 2 is a smart-phone based therapy management application for haemophilia patients and their physicians. It consists of an electronic patient diary (application) in interaction with a web based monitoring-interface for the attending physicians.

The target of evaluation consists of the following components:

• Provisioning of the electronic patient diary as well as the portal for physicians
• The user registration process
• All IT systems necessary for providing the electronic patient diary and the browser based application portal
• Relevant contractual clauses

Excluded from the target of evaluation are the following components:

• IT systems (clients) used by doctors and the smartphones that are used by patients to gain access to the Haemoassist^® 2 service
• Networks or active network components and further IT systems used to transfer or handle data

Every patient automatically receives a “welcome package” from his/her physician describing the Haemoassist^® 2 service in detail before he/she can download and use the Haemoassist^® 2 app. The declaration of consent form for patients is part of this “welcome package”.

The Haemoassist^® 2 service is limited to EU-member states and ist IT servers are located in Germany. The storage of personal data takes place only in Germany, but the Haemoassist^® 2 service can also be used by patients who live in Austria, Denmark and other countries of the European Union.

Technical Evaluator

Tobias Mielke

TÜV Informationstechnik GmbH
Langemarckstraße 20
45141 Essen
Deutschland

Legal Evaluator

Jörg Joachim Schlißke

TÜV Informationstechnik GmbH
Langemarckstraße 20
45141 Essen
Deutschland

Technical (and Legal) Evaluator (until monitoring in 12/2017)

Knut Haufe

PERSICON consultancy GmbH
Friedrichstraße 100
10117 Berlin
Deutschland

Legal Evaluator (until recertification in 08/2016)

Hannelore Jorgowitz

PERSICON consultancy GmbH
Friedrichstraße 100
10117 Berlin
Deutschland