Health Data Processing

Validity of Terms:

These terms outline the procedures governing the collection, storage, and processing of health data related to users of Alba Health’s products and services. These terms are provided for informational purposes at the point of purchase. However, prior to utilising Alba Health’s products and services, it is required that all users provide their consent in writing, as per the instructions provided by Alba Health from time to time. In the case of users who are below 18 years of age, written consent must be provided by all their legal guardians. Without the required consent — either from the user or the user’s legal guardian, as applicable — we regret to inform you that we are unable to proceed with the processing and storage of your health data.

General:

These terms apply to users of the products and services of Alba Health AB (‘The Company’) with Swedish organization number 559445-0198, address Grev Turegatan 30, 11438 Stockholm, Sweden. In these terms, you will receive information about the use of our product and services and how we process and store your data.

By giving your consent, you agree to these terms, and confirm that you have read and agreed to our Privacy Policy for personal data. We are unable to change the terms, unless confirmed in writing.

By giving your consent, you also confirm that: you are legally capable of entering into a binding contract; you are at least 18 years old; If you are registering on behalf of a minor, you are the legal guardian of that child and authorised to act on their behalf; and all information you provide is true and correct.

Before you start:

If you, your child or your partner (as applicable) are being treated for any chronic medical conditions, you should discuss these product and service procedures with your treating physician to ensure that your physician agrees that using our products and services is appropriate for you.

This product and service is not intended to have diagnostic value and will not contain any clinical diagnosis. Alba Health is a wellness product. It is not intended to diagnose or treat disease and it does not substitute for medical consultation.

How Does the Product and Service Work?

1. Provide consent

All users will need to read this consent form and provide their consent to these terms. Adult users must provide their own written consent. For children under the age of 18, consent must be provided by all legal guardians. All legal guardians of any participating child(ren) must carefully read and sign this consent form.

2. Answer questionnaire about lifestyle, diet and health

You will be asked to register and provide answers to a questionnaire about you, your child and family. This data is required for us to analyse your results. We may collect other types of information, including but not limited to images, video recordings, audio recordings, daily tracking questions.

3. Test kit and stool sample

If you have ordered a test kit for taking a stool sample for yourself or for your child, it will be sent to your home. Instruction manuals and all components are included in the kit. The kit must be used as described in the instruction manual and in no other way. After taking the sample you will send it back as instructed in the manual.

4. Sample processing

The stool samples taken using the product will be shipped from your home to our contract laboratory directly (in Germany) and will be processed within one month of being received. After analysis, the samples will be destroyed and no material from the samples will be kept. The contract laboratory will delete all data generated from the samples.

All mentioned samples will be processed by Zymo Research (laboratory contractor) at Mülhauser Str. 9, 79110 Freiburg im Breisgau, Germany. The received samples are coded, meaning they cannot be directly linked to you as an individual. The key to the code will be stored by Alba Health and will only be accessible by restricted personnel at Alba Health.

From the stool samples, DNA will be extracted and sequenced. We will only analyse microbial DNA and we do not analyse human DNA. The raw data will be stored in a secure way and in compliance with the General Data Protection Regulation (GDPR)and it will be transferred from the laboratory to Alba Health within 5 days from processing. Alba Health will store this data as previously described.

5. Receive your data and results

You can always access your submitted questionnaire data, please contact Alba Health. After we have analysed your sample results and data, you will receive a report with your sample processing results. The report will be delivered as instructed by Alba Health. This report will not have diagnostic value and will not contain any clinical diagnosis.

6. Online consultation with a certified Nutrition & Health coach or Nutritionist

After you have received your report, Alba Health will allow you to schedule an online consultation with a certified Nutrition & Health Coach or Nutritionist affiliated with Alba Health. This consultation is designed to provide you with personalised guidance based on your submitted questionnaire data and sample results. You will be notified of the scheduled time in advance and may request to reschedule the consultation up to 6 hours before the appointment time.

During the consultation, the Coach or Nutritionist will discuss your or your child’s gut health, dietary habits, and relevant lifestyle factors. The consultation will be conducted digitally via a secure video conferencing platform. No diagnostic or clinical advice will be provided during the consultation; the information provided is intended solely for educational and informational purposes and does not replace advice from a healthcare provider.

Participation in the consultation is voluntary. Any notes or recommendations provided during the consultation will be securely documented and stored by Alba Health in accordance with applicable data protection laws, including the GDPR. Only authorised personnel will have access to these records.

You may withdraw from the consultation or request deletion of consultation records at any time by contacting Alba Health (see contact details below).

7. Optional online consultation with a licensed Medical Doctor

In addition to the standard consultation, you may choose to purchase an optional consultation with a licensed Medical Doctor affiliated with Alba Health. This consultation may include the provision of diagnostic and clinical advice, and, where appropriate and within the doctor’s professional scope, the recommendation or prescription of medication, medical interventions, additional tests, medical diagnosis, and the formulation of a treatment plan.

This service is not included in the original purchase and requires an additional fee. If you choose to book this optional consultation, it will be conducted digitally via a secure video conferencing platform.

By booking this optional consultation, you consent to the sharing of your or your child’s questionnaire data and sample results with the Medical Doctor for the purposes of the consultation. Any records or notes generated during the consultation will be securely documented and stored by Alba Health in accordance with applicable data protection laws, including the GDPR. Only authorised personnel will have access to these records.

Participation in this optional consultation is voluntary. You may withdraw from the consultation or request deletion of consultation records at any time by contacting Alba Health (see contact details below).

Possible Consequences and Risks

We do not expect you, your partner nor your child(ren) to experience any discomforts nor side effects. The sample collection does not require invasive procedures, nor any discomfort. The stool collection kit must be used as described in the instruction manual and in no other way. In case questions or any problems might arise you can always contact us directly.

What Data is Collected?

To deliver our products and services and fulfil our commitments to you as a user or customer, we collect and record several types of personal and health-related information. This may include data about you, your child, or other family members, as applicable. The categories of data we collect are as follows:

• Personal information about you, your child and family, as applicable.

• Questionnaire data that includes questions about gender, ethnicity, lifestyle, household and health about you, your child and your partner, as applicable. Collected via the Alba Health App or as instructed.

• Stool sample data (bacterial DNA from your or your child’s stool)

Data Storage and Handling

Data collected will be stored with necessary safety measures taken to protect the data processed. This will be done in accordance with GDPR and applicable regulations to ensure that only Alba Health, our representatives and collaborators will have access. Your personal identifiable data will be completely separated from your questionnaire & health data and will not be shared with external collaborators outside of Alba Health. We store the data in the EU. In certain cases, we may engage personal data processors located outside the EU/EEA to handle the collected personal data. Before transferring personal data to these third parties, we implement appropriate protective measures to ensure they have adequate security measures in place.

The stool samples taken using the product will be shipped from your home to our contract laboratory directly (in Germany) and will be processed within one month of being received. After analysis, the samples will be destroyed and no material from the samples will be kept. The contract laboratory will delete all data generated from the samples.

From the stool samples, DNA will be extracted and sequenced. We will only analyse microbial DNA and we do not analyse human DNA. The raw data will be stored in a GDPR-compliant and secure way and it will be transferred from the laboratory to Alba Health within 5 days from processing. Alba Health will store this data as previously described.

For the purposes of the GDPR, Alba Health will be a data controller. The GDPR requires that we have a lawful basis for processing personal data about you. For this product, you have given your consent.

According to the GDPR you have a number of rights. You have the right to access the data about you free of charge, and you can request corrections if needed. You can also ask for the deletion of your data or restrict its processing. For further info about your rights, see:

https://www.imy.se/en/organisations/data-protection/this-applies-accordning-to-gdpr/the-data-subjects-rights/

If you want to exercise your rights or have any questions related to your rights, please contact Alba Health. The Data Protection Officer can be reached via email (see contact details below). If you are dissatisfied with how your personal data is handled, you have the right to file a complaint with the Swedish Data Protection Authority, which is the supervisory authority. The Swedish Authority for Privacy Protection can be contacted at:

Email: [email protected]
Website: www.imy.se

What Happens to my Samples and Data?

You have the right to refuse the storage of raw bioinformatic data from your samples without providing any explanation. If you consent to the storage initially, you can later withdraw (revoke) your consent without giving a reason. In that case, your raw data will be deleted or de-identified. If you want to revoke your consent, please contact Alba Health (details below). You always have access to the submitted data, please contact Alba Health staff. You have the option not to receive any analysis results if you prefer. If you wish so, please contact Alba Health (details below).

‍Insurance and Compensation

No insurance nor compensation is applicable for this product. 

Contact Information

For inquiries related to your rights, processing of yours, your child’s or your family’s health data or your consent, please contact us at [email protected]‍

Consent for Health Data Processing

Consent will be requested prior to the use of Alba Health’s product and services. In the cases where users are below 18 years of age, consent is required by all legal guardians of the child.

Use of Artificial Intelligence

Use of Artificial Intelligence

Alba Health provides AI-powered services, including but not limited to an AI chat, AI-generated result summaries (collectively, “AI Services”), to support users in understanding and managing their own or their child’s health and wellness. To provide these services, the AI processes certain personal and sensitive data, including:

• Personal identifiers: your or your child’s name, date of birth, and country of residence.

• Health, diet and lifestyle information collected in the Alba Health app.

• Gut microbiome results: your or your child’s gut health test results and related information such as the action plan.

• AI interaction data: messages, usage patterns, generated insights, summaries, and other outputs produced by the AI.

Use of the chat function

When using the AI chat, we ask you to exercise caution regarding the personal data you choose to share. The chat is intended solely for discussing results and information related to your use of the AI chat.

You should avoid sharing personal data about yourself, your child, or other individuals unless it is strictly necessary for the purpose of the conversation. In particular, you should refrain from sharing special categories of personal data as defined in Article 9(1) of the GDPR (such as data concerning health, racial or ethnic origin, religious beliefs, or similar sensitive information), unless it is clearly required for the purpose you are using the AI chat.

You should also avoid sharing other information that may be considered sensitive in nature, such as national identification numbers, payment card details, or similar financial information.

Legal basis for processing

The processing of your personal and health information for AI Services is based on your explicit consent, in accordance with Articles 6(1)(a) and 9(2)(a) of the GDPR.

• Consent for adults (above 18 years of age):

  By using Alba Health’s services for the first time, you provide explicit consent for AI-processing of your personal and sensitive health data as described in this Privacy Policy.

• Consent for minors (under 18 years of age):

  If you use Alba Health’s services on behalf of a child under 18 years of age, you confirm that you are the child’s parent or legal guardian and are authorized to provide consent. By using Alba Health’s services, you expressly consent to the processing of their personal and health data. Alba Health may take reasonable steps to verify parental or guardian consent where required.

Consent is given freely and separately from other Alba Health services. You may withdraw your consent at any time; see “Withdrawing Consent” below.

Purpose of processing

Your data is used solely to generate personalized responses and recommendations within the Alba Health app and AI interfaces. Alba Health does not use your personal data, health data, or AI interactions to train external or third-party large language models (LLMs) or for other external AI training purposes.

Automated processing

The AI uses automated processing to generate insights and recommendations based on your data. These outputs are for informational and educational purposes only and do not constitute medical advice, diagnosis, or treatment.

You may request human review, clarification, or additional support at any time by contacting Alba Health.

Data storage and security

We store AI logs, generated summaries, and related AI data securely and apply appropriate technical and organizational measures to protect them, including encryption and access controls.

We retain AI interaction data and the outputs generated only for as long as necessary to provide and maintain the service. This includes:

• While you have not withdrawn your consent to data processing;

• To ensure proper system performance, reliability, and operational maintenance;

• To prevent abuse, maintain security, and comply with legal obligations.

We reserve the right to delete AI interaction data and generated outputs at any time for these purposes. Once data is no longer required for the above purposes, it will be securely deleted or anonymized.

Withdrawing consent

If you withdraw your consent for Alba Health’s AI-services:

• All personal and health data associated with you or your child will be permanently deleted, including AI interaction logs, generated summaries, and related AI outputs

• You will no longer be able to access or use Alba Health’s services

Withdrawal of consent is final and may be requested by contacting Alba Health at the details provided in this Privacy Policy.

Your rights

You have the right to:

• Access, correct, or delete your personal data

• Withdraw consent at any time

• Restrict or object to processing

• Receive a portable copy of your data

• Lodge a complaint with a data protection authority

These rights may be exercised by contacting Alba Health using the contact details provided in this Privacy Policy.

How to provide consent

By using Alba Health’s AI Services, you actively and expressly consent to the processing of your or your child’s personal and health data as described in this Privacy Policy.

If you do not agree to such processing, you should not use Alba Health’s services.

Consent is a precondition for using AI Services, and, for minors, must be provided by all legal guardians of the child.