Regulatory Information

Products listed may not be available in all markets. As with all medical devices, please refer to the Instructions for Use.

Privacy policy

The protection of your special personal data is particularly important to us. Therefore, we inform you below about the processing of your data when using the Orthelligent app.

The Orthelligent Knee app is a freely available app. The Sensor Orthelligent app is approved for users aged 13 years and older.

This page is designed to inform users of our service about our policies regarding the collection, use and disclosure of personal information. In addition, this Privacy Notice regarding the use of the Orthelligent Knee Rehab, Orthelligent Prevention and Orthelligent Pro App may be updated from time to time. You can always find the latest version on this page.

Currently valid: Version 2.1 dated September 18, 2020

Person responsible according to the basic regulation on data protection

OPED Medical Inc.
5212 Bellewood Court, Suite 203
Buford, GA 30518,
USA
Tel.: 1-800-334-1906
E-Mail: support@opedmedical.com

Purpose of data collection

To support the recovery process after knee surgery, a sensor unit on the knee orthosis / bandage with the activated Orthelligent app offers you the ability to carry out movement tests and to maintain a pain and activity diary. The data is also used in anonymised form for research purposes.

The data set out below is used exclusively for these purposes. Only the persons within our company’s responsible technical departments have access to your data. Your data is stored in a data centre certified to ISO 27001. Your data is not passed on to other companies within the OPED Group or to third parties.

Data collection

To be able to provide you with this service, the app must process the following data from you:

Content data for identification:

  • Indication
  • Age group (10-year increments)
  • Gender
  • Side of the injured knee
  • Start of treatment
  • Date of surgery
  • Date of accident
  • Sensor ID

Information about the start/end/scope of use during active use:

  • Periodic processing and local storage of activity data (MOVE; LIE; SIT; DETACHED; OTHER; OFF)
  • Activity type and time stamp
  • Ongoing sensor data while a movement test is being carried out
  • Result values of the tests and fit index (relative to the healthy knee)
  • Pain value

The activity data is sent once a day to the OPED App Server. Test results are sent to the OPED App Server once the test is complete. Appropriate encryption methods are used to transfer this data. On the server, the sensor ID is stored in encrypted form in a database in order to ensure the anonymity of your data. Both the App Server and the OPED database are located in an external data centre (ISO 27001-certified).

Forwarding

The data is provided in anonymised form via the OPED database for medical research purposes to the scientific public.

Authorisation to collect data

We only process this data if you have given us your consent to do so. The Orthelligent App Sensor is approved for users aged 16 years and over.

Duration of storage

Your data is deleted as soon as it is transferred from the app to the app server or database. The data within the app on the mobile device is deleted when the app is deleted.

Data security

To protect your sensitive personal data appropriately from tampering and unauthorised access, we have taken a wide variety of technical and organisational precautions. In particular, we save your data exclusively in Germany in a certified data centre and protect your data during its transfer using state-of-the-art encryption methods.

Withdrawal of consent

You are able to exercise your right of withdrawal at any time without having to specify a reason and withdraw your declaration of consent with immediate effect. This is done by deactivating the app.

Your rights as the affected party

You are entitled to exercise the following rights at any time:

  • Information
  • Correction of incorrect personal data
  • Deletion
  • Restriction of data processing
  • Withdrawal
  • Transferability of data

You can contact the supervisory authority responsible for you at any time with a complaint. Your responsible supervisory authority depends on the federal state in which you live. A list of supervisory authorities (for the non-public sector) and their addresses can be found at:

www.bfdi.bund.de/DE/Infothek/Anschriften_Links/anschriften_links-node.html

If you would like more information about your personal data in our possession, our data protection officer will be happy to answer any queries you have regarding data protection.

OPED GmbH data protection officer

If you have any questions regarding data protection, please send us an e-mail or contact our data protection officer directly at datenschutz@oped.de

Additional Privacy Policy Declarations

The Orthelligent app is a free app. This SERVICE is provided by OPED GmbH at no cost and is intended for use as is.

This page is used to inform visitors regarding our policies with the collection, use, and disclosure of Personal Information if anyone decided to use our Service.

If you choose to use our Service, then you agree to the collection and use of information in relation to this policy. The Personal Information that we collect is used for providing and improving the Service. We will not use or share your information with anyone except as described in this Privacy Policy.

The terms used in this Privacy Policy have the same meanings as in our Terms and Conditions, which is accessible at www.oped.de unless otherwise defined in this Privacy Policy.

Location permissions

The Orthelligent app requires the location authorization to establish a Bluetooth connection to the required sensor unit.

Information Collection and Use

For a better experience, while using our Service, we may require you to provide us with certain personally identifiable information, including but not limited to Indication, Age group (10-year increments), Gender, Side of the injured knee, Start of treatment, Date of surgery, Date of accident, Sensor ID. The information that we request will be retained by us and used as described in this Privacy Policy.

The app does use third party services that may collect information used to identify you.

  • Google Play Services
  • Google Firebase (for Crash Reports)

The Service is using Firebase for Crash Reports only. We may use Google Analytics for Firebase. In this case we are able to collect data about App Users, including via identifiers for mobile devices (including Android Advertising ID and Advertising Identifier for iOS), cookies and similar technologies. User may opt-out by disabling crash report collection in their device settings.

Crash Report Logs

We want to inform you that whenever you use our Service, in a case of an error in the app we collect data and information (through third party products) on your phone called Log Data. This Log Data may include information such as your device Internet Protocol (“IP”) address, device name, operating system version, the configuration of the app when utilizing our Service, the time and date of your use of the Service, and other statistics.

Cookies

Cookies are files with a small amount of data that are commonly used as anonymous unique identifiers. These are sent to your browser from the websites that you visit and are stored on your device’s internal memory.

This Service does not use these “cookies” explicitly. However, the app may use third party code and libraries that use “cookies” to collect information and improve their services. You have the option to either accept or refuse these cookies and know when a cookie is being sent to your device. If you choose to refuse our cookies, you may not be able to use some portions of this Service.

Service Providers

We may employ third-party companies and individuals due to the following reasons:

  • To facilitate our Service;
  • To provide the Service on our behalf;
  • To perform Service-related services; or
  • To assist us in analyzing how our Service is used.

We want to inform users of this Service that these third parties have access to your Personal Information. The reason is to perform the tasks assigned to them on our behalf. However, they are obligated not to disclose or use the information for any other purpose.

Security

We value your trust in providing us your Personal Information, thus we are striving to use commercially acceptable means of protecting it. But remember that no method of transmission over the internet, or method of electronic storage is 100% secure and reliable, and we cannot guarantee its absolute security.

Links to Other Sites

This Service does not contain links to other sites.

Children’s Privacy

These Services do not address anyone under the age of 13. we do not knowingly collect personally identifiable information from children under 13. In the case we discover that a child under 13 has provided us with Personal Information, we immediately delete this from our servers. If you are a parent or guardian and you are aware that your child has provided us with personal information, please contact us so that we will be able to do necessary actions.

Changes to This Privacy Policy

We may update our Privacy Policy from time to time. Thus, you are advised to review this page periodically for any changes. we will notify you of any changes by posting the new Privacy Policy on this page. These changes are effective immediately after they are posted on this page.

Contact Us

If you have any questions or suggestions about our Privacy Policy, do not hesitate to contact us (see above).