decentralised clinical research

Data protection digest 18 May – 2 Jun 2024: decentralised clinical research, Meta’s new virtual assistant

In this issue, the personal data lifecycle in decentralised clinical research, Meta’s new AI chatbot, protections for organisations against data scraping, failed backup testing and spreadsheet error real examples, and much more.

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Decentralised clinical research

To support sponsors in designing their decentralised clinical research projects, the French data protection authority CNIL with other state agencies set up a pilot project, (from January to September 2024). 20 selected projects will receive targeted support and updated guidance, looking especially at the entire lifecycle of personal data processing: 

  • Roles and responsibilities, (oversight of incoming data);
  • Informed consent process, (interviews, leaflets, signatures);
  • Delivery of investigational products, (safety data, biological sample handling, home visits etc);
  • Data collection and management, (defining and handling source data);
  • Trial monitoring, (remote access).

In December 2022, the Commission published the European recommendations on decentralised clinical trials. It came after the COVID-19 pandemic, highlighting the importance of digital tools and decentralisation procedures in health research projects.

Meta’s AI virtual assistant under investigation in the EU

Norway’s data protection regulator reports that as of June 26, posts and photos on Facebook, (often of a private nature), and Instagram will be used to develop and improve Meta’s AI assistant service. This won’t include private messages to friends and family. Reportedly, Meta believes that the company does not need to ask for users’ consent since their interest in using the content outweighs the users’ interests and rights. The regulator has already received a complaint and started an investigation into the new practice and expects that there will be more complaints, both in Norway and in Europe. 

At the moment individuals in Norway can only object to it in a dedicated form on Facebook and Instagram if they wish.

Protections against Data Scraping

The Italian data protection authority has issued nonmandatory guidance on how to protect personal data published online by public and private entities in their capacity as data controllers from web scraping. It particularly targets the indiscriminate collection of personal data on the internet, carried out by third parties for training generative AI models. Some concrete measures, (taking into account the latest technology and the costs of implementation, in particular for SMEs) may include: 

  • creation of areas, accessible only upon registration, to remove data from public availability;
  • the inclusion of anti-scraping clauses in the terms of service of websites; 
  • the monitoring of traffic to web pages, to identify any abnormal flows of incoming and outgoing data; 
  • the technological solutions made available by the same companies responsible for web scraping, (eg, intervening on the robots.txt file).

Other official guidance

Data collection: Getting data collection right is a key to your overall GDPR compliance, as once you have understood and complied with the principles of your data collection, the same principles apply throughout the lifecycle of what you do with the data you have, explains the Guernsey data protection authority. It also offers new guidance regardless of the collection method, (in-person interviews, emails, online forms, paper forms, video surveillance, social media activity, phone calls etc). 

Dynamic data security: Data security measures must be viewed as dynamic, as opposed to a static, obligation, according to the Guernsey regulator. In its latest statistical research, the agency found that the long-established trend of emails being sent to the wrong person continues to be the most common reported breach. At the same time, the vast majority of breaches were still discovered by individuals, and not through system auditing or testing. The regulator requests a deeper understanding of the potential associated harms, ranging from “loss of confidentiality” to “emotional distress,” to properly assess the risk of such incidents. 

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‘Manage GDPR’:  The Spanish regulator AEPD published a new version of its Manage GDPR tool,(available in English). ‘Gestiona’ targets controllers and processors as well as data protection specialists. It allows managing the records of the processing activities, (ROPA), with up to 500 treatments, in an integrated way, and for different entities. It is now possible to manage the risk with privacy measures that the tool suggests for each identified risk factor. The tool is managed on the user’s device via their browser, without installing any application and storing the information locally. 

Legal processes

Anonymisation standard: The Quebec government enforced the Regulation respecting the anonymisation of personal information. It prescribes that once the purposes for which personal data was used are achieved, organisations, (including the private sector), have two choices: destroy or anonymise it for use only for serious and legitimate purposes. It will largely apply from 2025. 

UK Data Protection reform on hold: The Data Protection and Digital Information Bill falls ahead of a snap UK general election. As UK observers explain, any legislation that did not complete its passage by the end of the ‘wash-up’ on 24 May falls and will need to be reintroduced in the next Parliament. The draft bill was criticised for its flexibility towards data sharing in trade and innovation and state surveillance, threatening the adequacy decision granted by the EU. 

US Privacy and AI legislation: A good chunk of future privacy and AI bills has moved forward through state legislatures this past month. This includes the Maryland Age-Appropriate Design Code and other privacy acts, the Colorado Consumer Protections for AI Act, and the Vermont, Minnesota, and Kentucky Consumer Data Privacy Acts. California’s Bill on AI Accountability was read in the state Assembly, and the House of Representatives subcommittee advanced the American Privacy Rights Act Discussion Draft. 

Worldcoin on pause in Spain

The Worldcoin project committed to freeze its activity in Spain until the end of the year or until the final approval of its processing activities. The data protection authority of Bavaria, where the company has its main establishment in Europe, is progressing and is expected to conclude soon with a final binding decision. Worldcoin uses iris scans for unique identification with plans to expand for wider adoption of a global currency on the blockchain, explains the article. The iris structure is used to generate a unique identifying code that is saved on the Worldcoin decentralised blockchain to prevent others from replicating the code.

The biometric data is not stored by the scanning device, but is kept in the form of anonymised ‘IrisHash’. 

More enforcement decisions

Failed backup testing: The Danish data protection authority criticised the breakdown of NemID in 2022, where up to 1.5 million users experienced problems logging in to major public services. The data controller followed their emergency procedure to restore the operation with a backup solution. This appeared to be unavailable, and the test to establish the viability of the backup solution was last carried out two years before the collapse. Such tests show whether recovery can be done with existing guides/procedures, that hardware, software, and data can work together, and that recovery can happen quickly enough as the consequences usually increase with time.

Spreadsheet error: In the UK, the Police Service of Northern Ireland is facing a 750,000 pound fine for failing to protect the personal information of its entire workforce. Personal information including surname, initials, rank and role of all 9,483 serving officers and staff was included in a “hidden” tab of a spreadsheet published online in response to a freedom of information request. The error caused several officers to move house, cut themselves off from family members and completely alter their daily routines because of the tangible fear of threat to life. The cause of the data breach was more than trivial as there were insufficient internal procedures and sign-off protocols for the safe disclosure of information.

Data security

decentralised clinical research

US financial entities: If your business is covered by the FTC’s Gramm-Leach Bliley Safeguards Rule, an amendment that requires covered companies to report certain data breaches is now in effect. It lists thirteen distinct company categories, including payday lenders, mortgage lenders, finance companies, mortgage brokers, account servicers, cheque cashers, wire transfers, collection agencies, tax preparation organisations, credit counsellors, and other financial consultants. According to the amendment, financial institutions must report to the FTC any security breach involving the personal data of at least 500 customers as soon as feasible, but no later than 30 days after discovery.

Big Data

Microsoft vs schools: Microsoft’s 365 Education services violate children’s privacy by shifting the responsibility to the school administrations, states the NOYB privacy advocacy group. Digital service providers like Microsoft tend to designate educational bodies as data controllers in their Terms and Conditions. However, in practice, the schools have no control over the applications, their design, and data operations. In just one example, they cannot satisfy data access requests by individuals as they don’t hold the necessary data

Malware and data stealing: Law enforcement agencies in the US and EU announced massive operations against some of the most influential cybercrime platforms for delivering ransomware and data-stealing malware. They targeted droppers/loaders, (a custom-made program designed to surreptitiously install malware onto a system), deployed through email attachments, hacked websites, or bundled with legitimate software. Droppers are typically used in the initial stages of a breach, and they allow cybercriminals to bypass security measures and deploy additional harmful programs. 

ShinyHunters ransom: Meanwhile Ticketmaster in the US was hit by a data hack that may affect 560m customers, the Guardian reports. Cybercrime group ShinyHunters reportedly demanded 400,000 pounds ransom to prevent data from being sold. The unauthorised access was spotted by a third-party cloud database environment containing the company’s data. Earlier Bank Santander also confirmed being hacked by the same group. ShinyHunters claimed it had the data of 30m customers and staff details, 6m account numbers and balances, and 28m credit card numbers, and is demanding a ransom of 1.6m pounds. 

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