PRIVACY POLICY

About this notice

This website is operated by Biomedical Solutions Inc. (“BSI”), Nihomashi Life Science Building 2, 3-11-5 Nihombashihon-cho, Chuo-ku Tokyo, Japan.
For the purposes of this notice, BSI will be the controller, meaning BSI determines how and to what extent your personal data will be processed (the controller is also referred to in this notice as “BSI”, “we”, “our” and “us”).
This notice covers both our online and offline data collection activities and explains how and why we use your personal data, e.g. when we provide you with information you have requested from us, within the framework of any agreement pursuant to which you provide services to BSI, or when you simply use our websites and other digital platforms. In all cases, BSI understands and respects your privacy and acknowledges that in particular the information about an individual’s health and healthcare is confidential and sensitive.
In this notice, when we talk about personal data we mean any information that relates to an identifiable natural person – in this case, you.
You should read this notice, so you know what personal data we collect about you, what we do with it and how you can exercise your rights in connection with it. You should also read any other privacy notices that we give you, that might apply to our use of your personal data in specific circumstances from time to time. If you have any questions about this notice, you can contact BSI’s Privacy Officer at Biomedical Solutions Inc.., Nihomashi Life Science Building 2, 3-11-5 Nihombashihon-cho, Chuo-ku Tokyo or by submitting your query here.

In summary…

  • We use your personal data within the framework of any agreement pursuant to which you provide services to BSI, when you use our websites and other digital platforms, to provide you with information, where you have requested them, manage our business, comply with our legal obligations, and improve and monitor the performance of our digital platforms

  • We have measures in place to safeguard your personal data when we transfer it outside the European Union

  • We take steps to minimise the amount of personal data we hold about you and to keep it secure

  • We delete your personal data when we no longer need it, and we have policies in place to govern when that is

  • You have a number of rights in relation to your personal data

We are happy to answer your questions about any of the above – please just submit them here.

Who are you?

We process personal data for different purposes, depending on who you are. To find out for what specific purposes we process your personal data, you may choose from the below.

I am…

• a website visitor, just browsing the BSI website
• a healthcare professional providing services to BSI or utilizing product from BSI
• a patient treated with a product from BSI

CONTACT INFORMATION

Questions, comments, concerns or complaints regarding this Policy
or BSI’s processing of Personal Information
should be submitted to the BSI’s Privacy Officer at
privacy@biomsi.co.jp

Quickly find what you’re looking for by clicking the links below

1. Our data protection responsibilities

BSI is a "controller" in relation to its use of your personal data. We will maintain the confidentiality of and protect your Personal Data in accordance with our Policy and all applicable laws, including the General Data Protection Regulation 2016/679 (“GDPR”). This is a legal term – it means that we make decisions about how and why we use your personal data and, because of this, we are responsible for making sure it is used in accordance with applicable data protection laws. We are required by law to give you the information in this notice.

2. What types of personal data do we collect and where do we get it from?

2.1. The personal data we process about you broadly falls into four main categories:
(i) Contact Information
(ii) Agreement Information
(iii) Data concerning health
(iv) Browsing Information

2.2. We collect your personal information from limited sources. The table below sets out the different types of personal information that we collect and the sources we collect it from:

CategoryType of personal dataCollected from
Contact Information・Name
・Address
・Telephone number
・Organisation details (eg your place of work, practice, professional area, job title and organisation contact information)
・You
・Third Parties
Agreement Information・Contact Information (see above)
・Details relating to the services you provide to us, including service related communications with you
・Information about other people (eg your customers and/or staff) that you share with us in connection with your services or when ordering products from us
・Information you provide us when you interact with BSI (eg for a product order, conference, patient cohort)
・Billing and payment information
・You/your organisation’s banking details
・You
Data concerning health・Operating details
・Patient identification in case of clinical studies, materiovigilance or improvement of products and services quality
・Identification data (eg age, gender)
・Health data (eg medical history, clinical study participation, radiographic image)
・You

2.3. Please note that if you do not provide us with your Contact Information we will not be able to provide you with any information you request, and if you do not provide us with your Contact Information, Agreement Information, we will not be able to interact or contract with you.

3. What do we do with your personal data, and why?

3.1. We use your personal data for a number of different purposes.
We must always have a “lawful basis” (i.e. a reason or justification, prescribed by law) for processing your personal data. The table below sets out the purposes for which we process the different categories of your personal data and the corresponding lawful basis for that processing. For some processing activities, we consider that more than one lawful basis may be relevant – depending on the circumstances.

3.2. Website visitors

Category of informationPurposes of processingLawful basis
Contact InformationResponding to your enquiriesTo perform a contract with you
Legitimate interests (It’s important that we can respond to your enquiries)
Browsing InformationWe do keep access logs, but we do not monitor or analyze them. (We do not perform, monitoring and producing statistical information regarding the use of our platforms, and analysing and improving their functionality)Legitimate interests (We need to perform this limited routine monitoring to make sure our platforms work properly)

3.3. Healthcare professionals

Category of informationPurposes of processingLawful basis
Contact InformationResponding to your enquiries and orders for productsTo perform a contract with you
Legitimate interests (It’s important that we can respond to your enquiries)
Agreement InformationTo be able to keep accurate records of BSI’s communications with you. In addition, we may need the information you provide to comply with our regulatory monitoring and reporting obligations.To perform a contract with you
To comply with a legal obligation
Legitimate interests (to ensure transparency)
Agreement InformationDisclosure of payments according to regulatory requirementsConsent
To comply with a legal obligation
Agreement InformationTo understand how our products impact your patients, to track and respond to safety concerns and to further develop and improve our products and services. For example, we may create a record about you to decide whether to invite you to participate in various programs, panels of experts or surveys about our products or services.Legitimate interests (we need to use certain personal data for our business development strategies; we have a legitimate interest in making sure that we are continuously improving our product offering)
Agreement InformationCompliance with our legal obligations where data related to safety or Medical Device vigilance is concerned, including those related to adverse events, product complaints and patient safety.To comply with a legal obligation

3.4. Patient

Category of informationPurposes of processingLawful basis
Data concerning healthConducting a clinical investigationConsent
Data concerning healthMateriovigilance
Improvement of BSI’s products and services (quality)
Sending to healthcare professionals our experience and know-how
Consent
To comply with a legal obligation

3.5. Website visitors, healthcare professionals and patients

Category of informationPurposes of processingLawful basis
All InformationEstablishing and enforcing our legal rights and obligations and monitoring to identify and record fraudulent activity; Complying with instructions from law enforcement agencies, any court or otherwise as required by law; resolving any complaints from or disputes with you.To comply with a legal obligation

3.6. Cookies and similar technologies
For more information regarding how we use cookies and similar technologies in connection with your use of our website, please read our Cookie Policy.

4. Who do we share your personal data with, and why?

4.1. Sometimes we share your personal data with third parties, including the following:

4.1.1. other BSI group companies where necessary for the purposes described above;
4.1.2. alliance partners who co-commercialise our products in certain territories for the purposes described above;
4.1.3. courts, where we are asked to respond to a court order or other binding requests;
4.1.4. regulatory authorities and law enforcement agencies, where necessary for any investigations or to respond to enquiries in relation to our compliance with applicable law or regulations; and
4.1.5. professional advisors (such as lawyers and accountants).

These organisations will also use your personal data as a “controller” – they will have their own privacy notices which you should read, and they have their own responsibilities to comply with applicable data protection laws.

4.2. We also ask third party service providers to carry out certain business functions for us. These include:

4.2.1. IT support, cloud platform and data hosting providers who help us with the operation of our websites, infrastructure and applications;
4.2.2. Service providers assisting us in the organisation of events. arranging travel logistics and bookings;
4.2.3. Service providers who assist with supply chain logistics, delivery of and payment for products and related queries or complaints;
4.2.4. Third parties assisting on the collection and disclosure of transfer of value information to the public;
4.2.5. Communication service providers, including companies who send out surveys and communications on our behalf; and
4.2.6. Survey providers who help collate feedback for us.

We will have in place an agreement or confirm any terms and conditions of general agreements with our service providers which will restrict how they are able to process your personal data and impose appropriate security standards on them.

4.3. We may also share your Personal Data, including data concerning health, with:

4.3.1 Competent Authorities of European Union, the recipient of materiovigilance data;
4.3.2 Healthcare professionals in order to provide our expert opinion;
4.3.3 Clinical research organization (CRO) and other processors;
4.3.4 Institutional affiliation of healthcare professionals in order to obtain authorisation or provide them with information.

We will have in place an agreement with our service providers which will restrict how they are able to process your personal data and impose appropriate security standards on them.

5. Where is your personal data transferred to?

5.1. Since BSI is a Japanese company, we will need to transfer your personal data outside the European Union, in particular Japan. We will only make that transfer if:

5.1.1. that country ensures an adequate level of protection for your personal data;
5.1.2. the recipient or recipient country is subject to an approved certification mechanism or code of conduct with binding and enforceable commitments which amount to appropriate safeguards for your personal data;
5.1.3. we have put in place appropriate safeguards to protect your personal data, such as a contract with the person or entity receiving your personal data which incorporates specific provisions as directed by the European Commission;
5.1.4. the transfer is permitted by applicable laws; or
5.1.5. you explicitly consent to the transfer.

5.2. If you would like to see a copy of any relevant provisions, please contact us at the address above or submit your request here.

6. How do we keep your personal data secure?

6.1. We will put in place appropriate security measures to protect your personal data from unlawful or unauthorised processing and accidental loss, destruction or damage.

6.2. However please note that, in relation to any personal data you submit to us online, we cannot guarantee the security of data sent to us in this way. Transmission of data over the internet is at your own risk.

7. How long do we keep your personal data for?

7.1. We will only retain your personal data for a limited period of time, and for no longer than is necessary for the purposes for which we are processing it for. This will depend on a number of factors, including:

7.1.1. any laws or regulations that we are required to follow;
7.1.2. whether we are in a legal or other type of dispute with each other or any third party;
7.1.3. the type of information that we hold about you; and
7.1.4. whether we are asked by you or a regulatory authority to keep your personal data for a valid reason.

8. What are your privacy rights and how can you exercise them?

8.1. Where our processing of your personal data is based on your consent (see table at paragraph 3 above), you have the right to withdraw your consent at any time. If you do decide to withdraw your consent we will stop processing your personal data for that purpose, unless there is another lawful basis we can rely on – in which case, we will let you know.

8.2. Where our processing of your personal data is based on legitimate interests (see table at paragraph 3 above), you can object to this processing at any time. If you do this, we will need to show either a compelling reason why our processing should continue, which overrides your interests, rights and freedoms or that the processing is necessary for us to establish, exercise or defend a legal claim.

8.3. You have the right to (subject to certain limitations):

8.3.1. access your personal data and to be provided with certain information in relation to it, such as the purpose for which it is processed, the persons to whom it is disclosed and the period for which it will be stored;
8.3.2. require us to correct any inaccuracies in your personal data without undue delay.
8.3.3. require us to erase your personal data;
8.3.4. require us to restrict processing of your personal data;
8.3.5. receive the personal data which you have provided to us, where we are processing it on the basis of your consent or because it is necessary for your contract with us (see table at paragraph 3 above) and
8.3.6. object to a decision that we make which is based solely on automated processing of your personal data.
8.4. Please contact us by submitting a query if you would like to exercise any of your privacy rights.
8.5. We also encourage you to let us know if you have any concern about how we are processing your personal data so we can try to resolve your concerns. However, if you consider that we are in breach of our obligations under data protection laws, you are always entitled to submit a complaint with the competent supervisory authority.
8.6. We may decide to change this notice. If the change is fundamental or may significantly affect you, we will provide you with the updated notice in advance of the change actually taking effect. We encourage you to review the content of this notice regularly.

This website is for all those with an interest in Biomedical Solutions Inc.