Radiometer provides comprehensive security protection 

Protecting sensitive data and systems 

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  • ISO 27001:2013 certification
  • Multi-layered defense system
  • Strengthens patient data protection

Let us help keep your hospital’s digital network safe from risk

We offer:

  • security through design and product lifecycle management
  • ongoing risk monitoring and vulnerability management
  • built-in defense layers
  • regular security updates as required

This fortified, diversified approach allows you to use our devices without fear of compromise or downtime, so you can concentrate on delivering the best possible care to those most in need.

Radiometer Medical’s information Security Management System comprehensively complies with ISO 27001:2013. Our System’s broad scope includes:

  • Design and delivery of software systems, blood gas analyzers, transcutaneous blood gas and pulse oximetry monitors, and fluorescence immunoassay analyzers
  • Design, deployment, operation and servicing of digital services critical to supporting our analyzers on site
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A risk-based approach for enhanced protection

As the engineers and experts of our connected medical devices, we understand the importance of incessant risk monitoring. From preliminary designs through every stage of a solution’s lifecycle, we continuously identify and protect our devices from cybersecurity threats and vulnerabilities.

This risk-based approach ensures we enhance protection while minimizing any operational impact.

 


Software vulnerabilities

We assess our solutions’ software through the Common Vulnerability Scoring System (CVSS), an open industry standard framework for evaluating cybersecurity vulnerabilities in software.
Coordinated vulnerability disclosure

Penetration test

An independent third-party vendor conducts penetration tests of our products and services. These tests evaluate the security of a system and explore both identified and unidentified vulnerabilities.

A risk-based approach for enhanced protection

As the engineers and experts of our connected medical devices, we understand the importance of incessant risk monitoring. From preliminary designs through every stage of a solution’s lifecycle, we continuously identify and protect our devices from cybersecurity threats and vulnerabilities.

This risk-based approach ensures we enhance protection while minimizing any operational impact.

 


 


Software vulnerabilities

We assess our solutions’ software through the Common Vulnerability Scoring System (CVSS), an open industry standard framework for evaluating cybersecurity vulnerabilities in software.
Coordinated vulnerability disclosure

Penetration test

An independent third-party vendor conducts penetration tests of our products and services. These tests evaluate the security of a system and explore both identified and unidentified vulnerabilities.

Your partner in compliance and data security

Using our multi-layered security system will help you meet increasing security needs while protecting both patient data and connectivity from viruses and malware attacks.


Explore system features below:


Your partner in compliance and data security

Using our multi-layered security system will help you meet increasing security needs while protecting both patient data and connectivity from viruses and malware attacks.


Explore system features below:

 

Radiometer analyzers

  • Stored data including PII/PHI* is encrypted.
  • All unused ports are closed.
  • Audit trail registers all users logging on and off.
  • Windows Firewall is always enabled.
  • Application Control – only software approved by Radiometer can be installed.
 

Connection between devices and AQURE middleware

  • Customers are responsible for the PCs and servers placed in their hospital.
  • All access to AQURE data is managed through the application, based on specific rights for managed users.
 

Data in motion to Radiometer

  • No PII/PHI* data transfer, only analyzer performance related data
  • Outbound connection only through dedicated ports.
  • Authentication and outbound data encryption only through TLS protocols.
  • All certificates used during endpoint authentication are issued by Radiometer.
 

Data insights – Microsoft cloud

  • No PII/PHI* data stored.
  • Only analyzer and software performance-related rich data are stored (e.g., status and QC).
 

Radiometer field service engineer troubleshoots remotely

  • Access is restricted to certified Radiometer field service engineers
  • No PII/PHI data are visible or accessible at any time.
  • Any remote access to a device is logged with a timestamp, technician ID and a video of the entire session.
 

Radiometer network

  • Network for remote support trouble shooting.
  • No PII/PHI* data stored - only analyzer and software performance-related are stored.
  • All Radiometer’s digital solutions are enabled with multi-factor authentication.
 

Radiometer transcutaneous monitor

  • Patient and performance data located on the monitor are encrypted.
  • The device has three levels of user roles: key operator, operator, and service user.
  • Data transmission to other devices is possible via cable and network.
* PII = Patient Identification Information / PHI = Patient Health Information

We have established a multi-layered defense system

We share the responsibility of implementing and monitoring the various security layers with our customers. While the specifics of each layer will differ depending on the device or solution in question, they can broadly be categorized as:



Data at rest

Protection of the data through encryption, scrambling and anonymization, as appropriate.

Application

User management protects limited access via ID and password control, authentication, software installation control, and audit trails of activity.

Operating system

Based on Microsoft-supported operating systems hardened with restrictions imposed as appropriate, Application Control, Patch management and system updates tested prior installation.

Physical layer

Guidelines around responsibilities of customers and users to prevent unwarranted access.

Network

Firewall to protect data, port protection prevents breaches and allows for remote support and data insights.

Policies

Radiometer follows industry-recommended security best practices throughout our development lifecycle, deployment, and operations.

Application Control

Application Control is a means of ensuring only software signed and approved by Radiometer can be installed and run on the analyzer. Malware will lack the digital signature that approves the software and thus, cannot be installed. Only Radiometer can sign the software.

Application Control improves cybersecurity. If a program is not on our list of approved software, it cannot be run on the analyzer.

Patch management

Radiometer has established processes to monitor and evaluate the security updates of all third-party vendor software embedded in our solutions including Microsoft supported operating systems.

These updates are assessed with respect to applicability (relevance) and risk to decide when patching is needed. This can activate specific communication processes contingent upon the severity of an identified vulnerability.

Industry-recommended security best practice

We comply with the following standards:
  • ISO 27001:2013 Information Security Management
  • ISO 14971 Medical devices – Application of risk management to medical devices
  • ISO/IEC 80001-1 Application of risk management for IT networks incorporating medical devices
  • IEC 62304 Medical device software – Software lifecycle process
We comply with the following standards:
  • EC 62366 Medical devices – Part 1: Application of usability engineering to medical devices
  • HIPPA/HITECH
  • ANSI/NEMA HN 1 2019
  • GDPR – Data privacy policy is available at www.radiometer.com/DPN
We comply with the following standards:

We´ll help keep you secure and compliant

As part of our customer care offering, we continuously monitor and update your Radiometer solutions’ software to ensure compliance, add new functionalities and make necessary corrections.

Software updates and security packages for ABL and AQT analyzers are part of our various levels of service agreements.

We´ll help keep your software and Radiometer solutions current and secure as we support you in taking care of the patients at hand.

An integrated POC IT and Services solution

Security is part of Connect & Care.

Connect & Care is a customizable, total solution that connects and supports medical devices, data, and people to keep your POC testing setup running smoothly, placing you a step ahead to put life first.

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Radiometer uses Azure AD to provide our customers and partners secure access to documents, resources, and other services on our customer portal.

If your organization is already using Azure AD you can use the same credentials to access Radiometer's customer portal.

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Effective April 18, 2018

This Online Privacy Notice (“Privacy Policy”) explains how we handle the Personal Data provided to us on websites, mobile sites, mobile applications, and other digital services and products controlled by Radiometer Medical ApS, Åkandevej 21, 2700 Brønshøj, Denmark, that link to this Privacy Policy (collectively, “Radiometer Sites”).  Radiometer is the data controller for the processing of Personal Data under applicable law.

This Privacy Notice does not apply to third-party websites to which Radiometer Sites may link.

Types of Information We Collect Online

The types of Personal Data that we may collect while you use the Radiometer Sites are described in this section and include both information that you provide to us and information that we collect automatically when you use the Radiometer Sites.
For purposes of this Privacy Policy, “Personal Data” means information that identifies you or that could reasonably be used to identify you. Examples of Personal Data include name, address, telephone number, and email address.

Information You Provide

You do not have to register for a service or program to receive much of the information available through Radiometer Sites. However, some of our content is available only to registered or identified users and will require you to set up a profile or provide specific information about yourself in order to provide you the service.

Personal Data You Provide When Visiting Radiometer Sites

Radiometer collects Personal Data that you provide on Radiometer Sites, for example, when purchasing a product, to receive marketing products and information, contact Radiometer customer service, or respond to Radiometer questionnaires or surveys. This could include:

  • Contact Information such as your name, address, phone number, or email address
  • Registration Information such as your username and password
  • Remuneration information when you provide a service to Radiometer in your capacity as a healthcare professional
  • Employment, education and other background information when you inquire about employment with Radiometer
  • Payment information (such as banking information, payment card number, expiration date, delivery address, and billing address)
  • Content you may provide (for example, when you complete our Online Contact Form or submit other information).

 

Personal Data You Share During Other Interactions with Radiometer

You may contact Radiometer to ask questions, discuss your concerns, or report issues regarding our products. If you communicate with or request information from Radiometer, you may be prompted to provide your contact information as well as any Personal Data that is relevant to your request.

Information That May Be Collected Automatically

When you use the Radiometer Sites, we also may collect certain usage and device information automatically as described below.

IP Address

We may record the Internet Protocol (“IP”) address of your computer or other electronic device when you visit the Radiometer Sites. An IP address identifies the electronic device you use to access the Sites, which allows us to maintain communication with your computer as you move about Radiometer Sites and to customize content.

Cookies and Other Tracking Technologies

We also collect information about your use of Radiometer Sites through tracking technologies such as cookies and web beacons. A “cookie” is a unique numeric code that is transferred to your computer to track your interests and preferences and to recognize you as a return visitor. A “Web beacon” is a transparent graphic image placed on a Web site, e-mail or advertisement that enables the monitoring of things such as user activity and site traffic. These technologies help remember your preferences and allow us to bring you the content and features that are likely to be of greatest interest to you on the basis of “clickstream” data that shows your previous activities on Radiometer Sites.

We utilize Google Display Advertising (such as Retargeting with Google Analytics, Google Display Network Impression Reporting, DoubleClick Campaign Manager integration, and Google Analytics Demographics and Interest Reporting) to (1) show you our ads on other websites based on your prior visits to Radiometer Sites, and (2) better understand our ad impressions and use of ad services. In connection with the Google Analytics Demographics and Interest Reporting service, we may use data from Google's interest-based advertising or third-party audience data (such as age, gender and interests) with Google Analytics to understand and improve our marketing campaigns and Site content. 

Some of our online advertising takes place through Google Display Advertising. As part of this program, we use Google Analytics features such as Retargeting. In connection with that feature and others offered by ad networks, we and the operators of ad networks, including Google, may use third-party cookies (such as the DoubleClick cookie) – and in some cases first-party cookies (such as the Google Analytics cookie) – to inform, optimize and serve ads across the Internet, based on a user's past visits to Radiometer Sites. We also may show you ads from some of our affiliated companies when you visit Radiometer Sites. 

You can opt out of Google Ads by visiting http://www.google.com/ads/preferences. If you do not want your data used by Google Analytics, you can install the Google Analytics opt-out browser add-on at the Google Analytics opt-out page.

This Radiometer Site is not designed to respond to "do not track" signals received from browsers.

To learn more about cookies and other tracking technologies, including how to disable them, please visit http://www.allaboutcookies.org/. Please note that some cookies are essential to the functioning of our Sites and deleting or disabling them will reduce the site’s functionality.

Mobile Tracking

Some Radiometer Sites are available either as mobile applications or mobile sites that you can use on your mobile device. If you use a mobile device to access and use the Radiometer Sites, we may collect the following mobile-specific information in addition to the other information described above: device or advertising ID, device type, hardware type, media access control (“MAC”) address, international mobile equipment identity (“IMEI”), the version of your mobile operating system, the platform used to access or download the Radiometer Site (e.g., Apple, Google, Amazon, Windows), location information and usage information about your device and your use of the Radiometer Sites.

Information Collected from Other Sources

We may combine information about you from a visit to one Radiometer Site with information about you from visits to other Radiometer Sites. We may also combine information about you that is collected through the Radiometer Sites with information that we have collected offline, as well as with information provided to us by third parties.

How We Use Your Information

We use your Personal Data to provide you the product and services you request, communicate with you, improve your experience on the Radiometer Sites, generally improve our products and services and for other internal business purposes. These uses may also include the recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction of Personal Data. The Personal Data we collect about you may be stored for five years following the most recent interaction we have had with you, after which point it will be archived only for so long as reasonably necessary for the purposes set out above, in accordance with applicable laws.

Providing Product and Services You Request

If you choose to purchase a product or receive our services, we use the Personal Data that you provide through Radiometer Sites to manage your orders and invoices, to process payments, to respond to your questions, provide you the services you request and offer an optimal customer experience.

Marketing

You may also receive marketing information from Radiometer and related affiliates, such as offers regarding Radiometer related products or services, invitations to participate in surveys about our products, or notifications about special promotions. In such cases, we will use your contact and other Personal Data to send you marketing information.

Customized User Experiences

The Personal Data that you provide may be used to create customized offers, information, or services tailored to your interests and preferences. Also, we may use your IP address and the data that we obtain automatically through the use of cookies or similar tracking technologies to make our Radiometer Sites easier to use and navigate as well as to personalize the content provided on Radiometer Sites by anticipating the information and services that may be of interest to you.

Business and Product Improvement

In order to discover new facts that could help Radiometer better understand customer needs and help improve, develop, and evaluate product, services, materials, and programs. Radiometer analyzes the information that you have provided. For these purposes Radiometer does not use information that can directly identify you.

Site Analytics and Improvement

We may use the information that you provide and the information we collect automatically about your use of the Radiometer Sites to monitor user traffic patterns and preferences for site improvement, analytics and optimization.

Legal Basis for Processing

Under European data protection laws, Radiometer must have a legal basis to process your Personal Data. The legal basis that applies in a particular instance will depend on for which of the specific purposes described above Radiometer is processing your Personal Data:

  • In certain cases, Radiometer may ask for your consent to collect and process your Personal Data. Should you choose to provide your consent, you may later withdraw your consent by contacting us as described in the “Your Privacy Choices” section.  Please note that the withdrawal of consent will not affect processing which has already occurred.
  • In other instances, the processing of your Personal Data may be necessary in order to comply with an applicable law or regulation or for the performance of a contract to which you are subject. You may not be able to opt-out of this processing, or your choice to opt-out may impact our ability to perform a contractual obligation otherwise owed to you.
  • In still other instances, Radiometer may process your Personal Data based on Radiometer’s legitimate interests in communicating with you about our products and services, and about scientific research and educational opportunities.  You have the right to opt-out of all such processing of your Personal Data. You may do so by contacting us as described in the “Your Privacy Choices” section.  

 

Information We Share

We only share your Personal Data with third parties as described below. We do not sell or rent Personal Data to third parties for their own marketing purposes.

Third-Party Advertising and Online Behavioral Advertising

You may be provided with online advertisements of Radiometer products and services on third-party websites and mobile services that are tailored to you, for example, on the basis of information that you provide to Radiometer or a third-party website you are visiting, or of your browsing activity, purchases, or interests. These types of tailored online advertisements may come through several sources, such as the following:

  • We may share with our advertising service providers your non-identifying information that we have obtained from cookies and other tracking technologies on our Radiometer Web sites.
  • Some Radiometer Web sites participate in online behavioral advertising (this is also sometimes called re-target advertising or interest-based advertising). You can identify these sites by the “Advertising Choices” link in the footer. Our advertising network partners may place and use cookies on Radiometer Web sites and on other third-party Web sites to collect information about your activities in order to provide you with online advertisements that are based on your interests. When a Radiometer online behavioral advertisement is delivered to you, you will see an “Ad Choices” icon. Clicking on the icon or link will take you to a Web site where you can manage or opt out of the use of data about your browsing history that is used for the delivery of online behavioral advertisements. If you opt out, you may still see advertisements online, including advertisements from Radiometer that are based on other information (e.g., based on the content of the page being viewed rather than your prior clickstream activity). In some cases, data may still be collected about your browsing activity by these third-party advertisers, but they will not use this data to deliver advertisements that are based on your past online browsing behavior. You can also opt out now by clicking here.
  • Some Web browsers may transmit “do-not-track” signals to Web sites with which the browser communicates. As of April 18, 2018 of this Privacy Notice, an industry standard has not yet been established on how to respond to these signals. Therefore, Radiometer does not currently respond to these signals. As discussed above, you can opt-out from advertisers that use your browsing history to deliver online behavioral advertisements by visiting adchoices.

 

Affiliates, Vendors and Suppliers

We have relationships with suppliers and affiliated companies, who help us operate our business and for whom it may be necessary to have access to your Personal Data in the course of providing services to Radiometer. We will not authorize these parties to use your Personal Data for any purpose that is not related to Radiometer and its related affiliates business operation, and we do not share Personal Data from countries that require consent, unless appropriate consent has been obtained in advance to sharing with related affiliates. We require them to handle your Personal Data collected in accordance with this Privacy Notice.

Co-branded Sites

We may partner with other companies to provide you with content or services on a joint or “co-branded” basis. At a cobranded site, you will see both the Radiometer logo and the logo of the co-branding partner displayed on your screen. You should read the individual privacy policies of our co-branding partners, as they may differ in some respects from ours. Reading these policies will help you to make an informed decision about whether to provide your information to a given site.

Product Reports

If you contact Radiometer regarding your experience in using one of our products, we may use the information that you provide in submitting reports to the designated government regulatory authority, as required of us by law.

Legal Rights and Obligations

In certain limited circumstances, Radiometer may need to disclose your Personal Data in order to comply with a legal obligation or demand, such as to comply with reporting obligations to our governing regulatory authorities regarding the safety of our products, or in connection with the sale or transfer of one of our product lines or divisions, which includes the services provided through one or more of the Radiometer Sites. In such instances, we will take measures to protect your Personal Data to the extent possible. We also reserve the right to use Personal Data to investigate and prosecute users who violate our rules or who engage in behavior that is illegal or harmful to others or to others’ property.

Change in Organization

In the event Radiometer decides to reorganize or divest our business through sale, merger, or acquisition, Radiometer may share Personal Data about you with actual or prospective purchasers.  We will require any actual or prospective purchasers to treat this Personal Data in a manner consistent with this notice.

Children Privacy

Radiometer does not knowingly collect or use any Personal Data directly from children on Radiometer Sites (Radiometer defines as “children” as minors younger than 18). We do not knowingly allow children to order our products, to communicate with us, or to use any of our online services. If you are a parent and become aware that your child has provided us with information, please contact us using one of the methods specified below, and we will work with you to address this issue.

Your Privacy Choices

You have the right to see and get a copy of Personal Data about you that we maintain as well as to ask us to make corrections to inaccurate or incomplete Personal Data about you.  

You have the right to receive data you have provided to us in a machine-readable format and to transmit that data to another controller. 
You may also request the erasure of your Personal Data or the restriction of its processing, or object to the processing of Personal Data about you. 
To seek access to Personal Data about you, to file a concern, complaint, or request for correction, or to opt-out of particular programs, please:

  • contact our Legal & Compliance team by clicking on the “Contact Us” link on the Radiometer Site you are using (please add “Privacy” in the headline)
  • contact us by using the Radiometer contact information on the Radiometer mobile application you are using
  • contact us by emailing us at privacy@radiometer.dk.

 

You may also send a letter to the following address:
Radiometer Medical ApS Attn: Legal & Compliance (Privacy)
Åkandevej 21
2700 Brønshøj
Denmark

For more information about your privacy rights, or if you are not able to resolve a problem directly with us and wish to make a compliant, contact your local data protection authority, if applicable.

In all communications to Radiometer, please include your email address, the website address, mobile application, and/or the specific Radiometer product to which you provided Personal Data (e.g., www.radiometer.com), and a detailed explanation of your request. If you would like to delete, amend, or correct your Personal Data and are contacting us by email, please put “Deletion Request” or “Amendment/Correction Request” in the subject line of the email. We will respond to all reasonable requests in a timely manner and may need to further confirm your identity in order to process certain requests.

Data Security

Radiometer maintains reasonable technical, administrative and physical controls to secure any Personal Data collected through the Radiometer Sites. However, there is always some risk that an unauthorized third party could intercept an Internet transmission, or that someone will find a way to thwart our security systems. We urge you to exercise caution when transmitting Personal Data over the Internet, especially your financial-related information. Radiometer cannot guarantee that unauthorized third parties will not gain access to your Personal Data; therefore, when submitting Personal Data to Radiometer Sites, you must weigh both the benefits and the risks.

Third Party Sites and Social Media Plug-ins

This Privacy Notice does not apply to third-party websites to which Radiometer Sites may link. Radiometer Sites may use social media plug-ins (e.g., the Facebook “Like” button, “Share to Twitter” button) to enable you to easily share information with others. When you visit Radiometer Sites, the operator of the social plug-in can place a cookie on your computer or other electronic device that enables that operator to recognize individuals who have previously visited our Site. If you are logged into the social media website (e.g., Facebook, Twitter) while browsing on our Radiometer Site, the social media plug-in allows that social media website to receive information that you have visited our Radiometer Site. The social media plug-in also allows the social media website to share information about your activities on our Radiometer Site with other users of their social media website. These sharing settings are managed by the social media website and governed by its privacy policy.

Accessing Our Sites Globally

This site is owned and operated by Radiometer in Denmark, but the information you provide will be accessible to our affiliates, vendors, and suppliers in other countries in accordance with this policy. Furthermore, if you are visiting this site from a country other than Denmark, your communication with us will necessarily result in the transfer of information across international borders. The level of legal protection for Personal Data is not the same in all countries; however, we will take the security measures described in this Privacy Notice in an effort to keep your information secure. By using this site, you understand that your Personal Data may be stored and processed in the United States and in any country to which we may transfer your information in the course of our business operations.

Notice to California Residents 

Subject to certain limits under California Civil Code § 1798.83, California residents may ask us to provide them with (i) a list of certain categories of Personal Data that we have disclosed to third parties for their direct marketing purposes during the immediately preceding calendar year, and (ii) the identity of those third parties. To make this request, California residents may contact us at privacy@radiometer.dk.

Changes to Our Privacy Policy

We will only use Personal Data in the manner described in this Privacy Policy in effect when the information was collected from you or as authorized by you. However, and subject to any applicable consent requirements, we reserve the right to change the terms of this Privacy Policy at any time. Any changes to this Privacy Policy will be reflected on this page with a new effective date. Radiometer encourages you to review this Privacy Policy regularly for any changes. Any Personal Data collected upon your continued use of Radiometer Sites will be handled in accordance with the currently-posted Privacy Policy.

Privacy and Security

Radiometer Medical ApS (“Radiometer”), along with its affiliates and subsidiaries respect your privacy, value our relationship, and are committed to safeguarding your privacy. We understand the importance of privacy to our customers and visitors to the Radiometer websites. Our use of Personal Data is governed by our Privacy Policy and by accessing and using the Radiometer websites, you agree to be bound by that Privacy Policy.

You recognize and agree that when submitting your personally identifiable information to Radiometer websites, while Radiometer has safeguards in place to prevent unauthorized access or interception, there is no absolute guarantee of security. IN THE UNLIKELY EVENT OF AN INTERCEPTION OR UNAUTHORIZED ACCESS DESPITE OUR EFFORTS, RADIOMETER SHALL NOT BE RESPONSIBLE FOR SUCH INTERCEPTIONS OR UNAUTHORIZED ACCESS, OR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS) SUFFERED BY A CUSTOMER OR USER, EVEN IF RADIOMETER HAS PREVIOUSLY BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, RADIOMETER DOES NOT WARRANT, EITHER EXPRESSLY OR IMPLIED, THAT THE INFORMATION PROVIDED BY ANY CUSTOMER SHALL BE FREE FROM INTERCEPTION OR UNAUTHORIZED ACCESS, AND DOES NOT PROVIDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. EACH CUSTOMER IS RESPONSIBLE FOR MAINTAINING THE CONFIDENTIALITY OF HIS OR HER OWN PASSWORD.

 

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