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Some secrets are so secret that no one knows about them. Until recently that described the secrets locked within our DNA. But a key to consumer confidence in the burgeoning genetic testing marketplace is the extent to which people can depend on a companys promise that Your secrets safe with us. In its first case focused on the privacy and security of genetic information, the FTC alleges that San Francisco-based Vitagene, Inc. now known as 1Health.io failed to live up to its promises and unfairly changed material privacy terms without customers consent. The proposed settlement and other recent actions send a loud-and-clear message that the FTC is fully committed to the protection of consumers health information.

After consumers paid between $29 and $259, sent a saliva sample to Vitagene, and answered an online questionnaire about their health history, family history, and lifestyle, the company provided them with a personalized Health Report. The Report included the customers full name and an assessment of their risks for developing a host of health problems.

Using images of locks, keys, and secure clouds, the companys website was replete with claims about the care with which it promised to handle consumers genetic information. Here are just a few of the companys pledges.

Nice privacy and security talk, but according to the FTC, Vitagene was more talk than action. Youll want to read the complaint for details, but part of the story started in the cloud. As a component of its IT infrastructure, Vitagene used a well-known cloud service provider for storing confidential information, including consumers Health Reports and DNA data. Vitagene allegedly didnt use built-in measures to secure the information and instead stored it in buckets that made it possible for anyone with internet access to see the detailed Reports of nearly 2,400 Vitagene customers. Also accessible: raw genetic data of at least 227 other customers, sometimes identified by first name. While Vitagene promised to exceed industry-standard security practices, the FTC says the company didnt encrypt that data, didnt restrict access to it, didnt monitor access, and didnt inventory it to help ensure its security. The complaint also charges that Vitagene didnt take steps to ensure that a lab that analyzed many of the DNA samples had a policy in place to destroy them.

Whats more, the complaint alleges that over a two-year period, Vitagene received three separate warnings that it was storing customers health and genetic information in a way that made it publicly accessible. Warning #1: a July 2017 message from the cloud service provider that Vitagene had configured its data to allow read access from anyone on the Internet. The email included links to an account console and information about how to restrict access. The response from Vitagene: Crickets.

Warning #2 came from a security company that conducted a web app penetration test in November 2018 and found that uploaded DNA data was being stored . . . without any access controls. The complaint alleges that Vitagene again failed to rectify the situation.

Warning #3 was a June 2019 email from a security researcher sent to Vitagenes support inbox. After the researcher contacted the media, the FTC says the company finally investigated its public exposure of customers health information. However, because Vitagene hadnt monitored who had accessed or downloaded the data, it couldnt determine who else might have seen the information.

Vitagenes alleged missteps didnt end there. In 2020, the company changed its privacy policy by retroactively expanding the types of third parties with which it may share consumers data to include grocery chains, dietary supplement manufacturers, and the like. And it did that without notifying customers who provided their data under the former, more restrictive privacy policy and getting their consent.

The complaint charges that the companys promises that it exceeded industry security standards, stored DNA results without identifying information, deleted data at consumers request, and saw to it that physical DNA samples were destroyed were false or misleading. Whats more, the FTC alleges that the companys after-the-fact privacy policy changes about sharing sensitive personal information with third parties was an unfair practice, in violation of the FTC Act.While Vitagenes original privacy policy stated that a customers access or use of the companys services after the company posted a revised privacy policy meant that the consumer had accepted the revised terms, that language didntexcuse Vitagene from its obligation to give notice and get consumers consent before making material retroactive changes to its privacy practices. Furthermore, the complaint alleges that Vitagenes conduct was unfair even though the company has not yet implemented the broader information sharing practices set forth in its revised privacy policies.

To settle the case, 1health.io has agreed to implement a comprehensive information security program, including every-other-year third-party assessments. In addition, a senior executive must certify annually that the company is complying with the terms of the settlement. The proposed settlement also includes a $75,000 financial remedy. Once the settlement appears in the Federal Register, youll have 30 days to file a public comment.

What can other companies take from the FTCs action?

Sensitive health information including genetic data requires intensive care. If your company collects or maintains consumer health information, youve raised the bar on the privacy and security standards you must implement. Take particular care to substantiate the promises you make about your data practices. (By the way, if you havent read the FTCs May 2023 Policy Statement on Biometric Information, set aside time now.)

Just because data is in your possession doesnt mean its yours. Collecting consumers data doesnt mean youre free to do with it as you please. Consumers have a right to know in advance how you intend to use their information and you have the legal obligation to live up to your representations. That means if you want to change your practices down the road, a bait-and-switch modification to your privacy policy wont suffice. Youll need consumers affirmative express consent for any new uses of their data.

When it comes to security, keeping your data in the cloud doesnt mean you can keep your head in the clouds. The FTC has long said that storing data in the cloud doesnt give a company a free pass on security. Its still your responsibility to take reasonable steps to secure your data for example, by properly configuring cloud security settings and by inventorying and auditing your cloud storage. As the FTCs Request for Information about cloud computing makes clear, sellers of cloud technology and the companies that use their services share the responsibility to secure consumers personal information.

Respond to credible warnings about potential security lapses. The complaint against Vitagene alleges multiple instances in which the company failed to heed alarms others including the provider of its cloud storage had sounded about the security of its cloud-based information. Do you have systems in place to make sure those alerts get to the right people and get the immediate attention they deserve?

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Privacy and security of genetic information: Putting DNA companies ... - Federal Trade Commission News