PRIVACY NOTICE PURSUANT TO ART. 13 et seq. of EU Reg. 679/16 on the protection of natural persons with regard to the processing of personal data (GDPR)

Version 1.3 of 03/07/2025

Smartwatch App “PD-Watch”

 

From: Data Controller (Biomedical Lab) To: User

 

BIOMEDICAL LAB SRL (hereinafter BIOMEDICAL or We) provides you with the following information regarding the processing of your Personal Data that will be carried out by BIOMEDICAL,  for the provision of the service concerning the use of the PD-Watch app.

PD-Watch is an application developed for research purposes and for delivering the services associated with PD-Watch data processing, as described below.

PD-Watch is designed to collect and analyze body movement data using a smartwatch equipped with an accelerometer and sensors. The smartwatch continuously records movement patterns, which are then transmitted securely and automatically to the PD-Watch server. These data are processed using advanced algorithms to provide reports containing insights into motor symptoms and possible conditions related to Parkinson’s disease.

The data processing is carried out using various algorithms, including those described below:

  1. Screening of parkinsonian motor syndromes.
    Battista L, Romaniello A. A New Wrist-Worn Tool Supporting the Diagnosis of Parkinsonian Motor Syndromes. 2024; 24(6):1965. https://doi.org/10.3390/s24061965
    https://www.mdpi.com/1424-8220/24/6/1965
  2. Tracking of Parkinson’s motor signs.
    Battista L, Casali M, Brusa L, Radicati FG, Stocchi F. Clinical assessment of a new wearable tool for continuous and objective recording of motor fluctuations and ON/OFF states in patients with Parkinson’s disease. PLoS One. 2023 Oct 5;18(10):e0287139. DOI: 10.1371/journal.pone.0287139. PMID: 37796842; PMCID: PMC10553324.
    https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0287139

In order for you to use the PD-Watch app, we require certain personal data. Note that if you choose not to provide us with your personal data, it will not be possible for you to use the app. You further acknowledge that giving your consent for the processing of personal data as described in this Notice is entirely voluntary, and you are not under a legal obligation to provide any personal data.

With this premise, we inform you that BIOMEDICAL, as the data controller, will process your data, which qualifies as Personal Data under Article 4, No. 1 and 15 of EU Regulation 679/16 (hereinafter “Privacy Regulation”), in compliance with the Privacy Regulation.

 

What personal data do we collect about you?

During the provision of the service, BIOMEDICAL will collect and generate information about you. This information includes:

  1. Personal data necessary for the provision of the service: Data generated during the use of the PD-Watch app by the User;
  2. Health Data: data collected through smartwatch sensors, such as the accelerometer and the wear detection system, which are subsequently processed to generate the final report.

The mentioned categories of data are collected from the users themselves, as well as automatically through the wearable device and the app.

The PD-Watch app for smartwatch provides a code that can be used to link the data with the user report, which is accessible via the PD-Watch server at api.pdwatch.net.

The optional, explicit, and voluntary sending of emails to the addresses indicated on this website involves the subsequent acquisition of the sender’s address, necessary to respond to requests, as well as any other personal data included in the email.

The optional, explicit, and voluntary request/registration through specific web forms on the websites www.biomedicallab.it and www.pdwatch.net involves the subsequent acquisition of all the data entered in the fields filled out by the user, necessary to process their requests.

By sending emails to the email addresses indicated on the website and voluntarily checking the “consent” box, you consent to the processing of the data sent in order to respond to the requests made, in accordance with the purposes and methods contained in this Notice.

 

How do we use your personal data?

We use your personal data for the following purposes:

  1. To provide you with the requested service;
  2. To comply with legal, regulatory, and other mandatory requirements;
  3. To assess, exercise and/or defence in the competent courts and/or for fulfilling legal, tax and accounting obligations;
  4. To carry out research activities aimed at evaluating the efficacy and safety of PD – Watch, also with the cooperation with hospital institutions.

Personal data will be processed – in accordance with the principles of fairness, lawfulness and transparency – using manual and/or telematic tools, with logic strictly related to the purposes of the processing and, in any case, ensuring the confidentiality and security of the data and compliance with the specific obligations established by law.

According to legal requirements, data processing takes place in Italy.. For further information, you may contact the Data Controller. However, should it become necessary, the Data Controller may transfer the servers outside the EU countries. In such cases, the Data Controller ensures that data transfers outside the EU countries will be carried out in compliance with applicable legal provisions, following the standard contractual clauses stipulated by the European Commission.

 

What are the legal bases for processing your personal data?

The legal basis for processing personal data is the consent of the data subject.

  • Explicit Consent for the processing of basic Personal data (Article 6(1)(a) of the Privacy Regulation).
  • Explicit Consent for the processing of Health data (Article 9(2)(a) of the Privacy Regulation).
  • Legitimate interest for the processing of data of purpose no. 3 (Article 6(1)(f) of the Privacy Regulation).
  • Performance of the contract (Article 6(1)(b) of the Privacy Regulation).

 

How long do we retain your personal data?

We will retain your personal and generic data for the duration of the service and for a maximum of 5 years after its termination to comply with legal requirements and to protect BIOMEDICAL in case of legal actions against it or an investigation or audit involving BIOMEDICAL.

We will retain your health data for the duration of the service.

In case of processing for research purposes, data will be retained for the duration requested by the law.

 

With whom do we share your personal data?

We share some of your personal data with:

  • When applicable, your personal data will be process by Hospital Institution, competent ethical committee and, investigators, medical staff, or researchers may have access to your personal data (in the case of research purposes);
  • Our professional consultants;
  • Regulatory authorities, government agencies, law enforcement, and judicial authorities, both local and foreign, as well as public entities, ministries, insurance companies, and similar organizations, if applicable;
  • Third parties designated as Data Processors;

In case you have granted your consent, your personal data will be shared with your physician.

Your data will not be disseminated.

 

Protection of Your Personal Data

The Data Controller processes your pseudonymized data in compliance with the highest principles of lawfulness and fairness. Therefore, appropriate technical and organizational measures are always adopted to ensure information security. In particular, processing is carried out using IT and/or telematic tools, with organizational methods and logic strictly related to the indicated purposes.

In addition to the Data Controller, in some cases, categories of personnel involved in the organization of the Web Site (administrative, commercial, marketing, legal staff, system administrators) or external entities (such as third-party technical service providers, postal couriers, hosting providers, IT companies, communication agencies) may have access to the data.

Employees and any connected subjects are bound by confidentiality principles and have accepted strict conduct obligations.

Therefore, only authorized personnel can view and process Your personal data.

 

Updates

This privacy policy may be updated or supplemented by BIOMEDICAL. Any changes will be announced in advance, and in any case, the updated version of the policy will be available for consultation at: https://www.biomedicallab.it/privacy-notice-smartwatch-app-pd-watch/

 

Conclusion and Acceptance

By providing us with any personal data, using our Web Site and services in any way, and expressly accepting this Policy where required, the user establishes a binding relationship with the Data Controller. By continuing to use the service, you acknowledge having had the opportunity to review and consider this Privacy Policy and accepts it. This means that the user also consents to the use of the information and the method of disclosure described.

By using the service and expressing consent to its use, you:

  • Consents to:
    • The use of the app and service;
    • The transmission of personal data from the medical/research staff to BIOMEDICAL for the execution of the service;
    • The transmission of personal data, including processed data, from BIOMEDICAL to the medical/research staff for the execution of the service.
  • Accepts that:
    • Data processing will take place in compliance with fundamental rights and freedoms, as well as the dignity of the individual concerned, with particular reference to confidentiality, personal identity, and the right to personal data protection.
    • Processing is exclusively aimed at the correct and complete execution of the service, as well as compliance with other obligations imposed by law.

What Are Your Rights?

The Data Controller informs the user of the existence of a broad range of rights under Regulation (EU) 2016/679. More specifically, based on:

  1. a) Article 15: The right of the data subject to request access to personal data from the Data Controller;
    b)Article 16: The right to rectify provided data;
    c) Article 18: The right to integrate or restrict the processing of data concerning the user or to object, for legitimate reasons, to the processing;
    d) Article 20: The right to data portability in compliance with Article 20 of the Regulation (EU), if applicable and in accordance with Biomedical’s intellectual property rights;
    e) Article 17: The right to request the deletion, transformation into anonymous form, or blocking of data processed unlawfully, including data whose retention is no longer necessary for the purposes for which they were collected or subsequently processed;
    f) The right to obtain confirmation that updating, rectification, integration, deletion, blocking, or transformation operations have been correctly carried out or initiated.

In the event of a violation of the regulation, the user should be aware that they have the right to file a complaint with the Data Protection Authority, which is the supervisory authority in Italy.

These rights can be exercised without formalities by sending a request to the Data Controller via:

  • Letter addressed to BIOMEDICAL LAB S.R.L., Via Pienza, 94, 85100 Potenza, Italy
  • Email to: privacy@biomedicallab.it

A response to the request will be provided promptly.

You are aware that, in the event of failure to consent to the processing of their Personal Data, you will not be able to use the Services.

I agree with the process of my particular data (health data) to obtain the service from BIOMEDICAL

I agree to share the report with the physician

I agree with the process of my particular data (health data) for research purposes