ALETTA 1.0
1 Purpose
ALETTA is real-world data management platform developed by MYCB1 Group B.V, that is built in with standardized
instruments for measuring generic health status that is designed for self-completion and as such captures information directly
from the respondent, thereby generating data that conforms with the general requirement of all Patient Reported Outcome
(PRO) measures.
ALETTA has the following benefits for a clinical practice:
- Enhance decision-making
- Complement Patient management
- Identify issues for discussion ahead of the clinical consultation
- Improving the efficiency of the clinical encounter
- Identify issues for discussion that would not normally be addressed - Access to real-time data and feedback
- Analyze Patient trends on a timeline
ALETTA 1.0 works only with MYCB1 prescription medicines.
2. Process Overview
ALETTA includes a mobile app for Patients, a dashboard for clinicians (Doctors), a dashboard for the Pharmacy and a
dashboard for statistical analysis.
The high level workflow process is as follows: The Patient receives the medication from MYCB1 and scans the drugs with the
ALETTA app on her/his mobile phone. This activates the validated standardized instruments for measuring generic health
status. The Patient is now ready to report his/her health status during the usage of the drugs. ALETTA collects this data and
makes it insightful for the Doctor via the ALETTA Doctor dashboard.
MYCB1.COM
Watteaustraat 5 II, 1077ZH
Amsterdam The Netherlands
ALETTA 1.0 User Guideline - MYCB1 Group B.V © 2021 7
3. Secure information processing
ALETTA safeguards the personal data of the Patient from tampering and unauthorized access. All communication between the
app and ALETTA server is secured via HTTPS. Authentication is done on a personal and medicine level. Personal
authentication is performed by the Pharmacy which verifies the identity of the Patient manually before an account is created for
the Patient to use the ALETTA app..
Furthermore, the ALETTA app includes proprietary medicine authentication technology as a counterfeit medicine-detection tool.
Before the Patient is allowed to use the app, the Patient needs to scan the medicine. ALETTA will then verify the authenticity of
the MYCB1 medicine. After successful verification, the Patient can proceed to use the app.
MYCB1 complies with the international standard for information security ISO 27001:2017 and the standard for information
security for the Dutch healthcare sector NEN 7510-1:2017. Further information regarding the scope of this certification and
applicability of the management system requirements can be obtained by contacting the certified organization Brand
Compliance at brandcompliance.com.
4. How to Use ALETTA correctly
The ALETTA app requires the Patient to fill in the questionnaire on a frequent basis according to the doctor’s instructions,
during the usage of the prescribed MYCB1 medicine. The questionnaire is to address the Patient’s Quality Of Life. It’s important
that the Patient itself answers the questions to ensure authentic answers. This guarantees the treating doctor that the
questionnaire has been filled in correctly.
5. Physical Impaired Patients
In case the Patient is unable to fill in the questionnaire on the app him/herself due to physical impairment (bad eyesight, unable
to handle the mobile app on the phone physically or other), the Patient is advised to ask somebody to assist him/her by reading
the questions aloud and filling in the answers for the Patient directly. This needs to be done every time the Patient needs to
report his/her health status.
6. Potential Health Consequences
There are no potential health consequences when using the ALETTA application or mobile app. It is not a medical device, and
has no medical applications.