The importance of conscientious health data collection in European clinical trials

Hogan Lovells

Hogan Lovells

Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All of this “big data” also have high value, not only for clinical trials, but also for further analysis and R&D to improve products.

But the process, regulation, and sensitivity of health care data itself is a serious concern, says Patrice Navarro, counsel in the Hogan Lovells Paris office. And that’s where the General Data Protection Regulation (GDPR) comes into play. Collection and processing of data is regulated by both the GDPR and, indirectly, by local public health regulations. To use the data and fully extract its potential value, it’s critically important to ensure that data collection, processing, and security is in compliance with the GDPR and local regulations.

In this interview, Patrice Navarro explores the highly regulated realm of health data and clinical trials in Europe, and the numerous actors and stakeholders involved in personal data use and protection.

Why are clinical trials increasing in both importance and number?

Patrice Navarro: Until recently, clinical trials were mainly sponsored by pharmaceutical companies to support their marketing authorization request for a drug. Now, they are also needed post-market to show the benefit of their products. In addition, medical devices have increased in use and importance and medical device manufacturers are obligated to perform clinical trials to prove their devices have the right effect.

In order to do that, you need more post-marketing trials and more papers published in peer-reviewed journals to convince HCPs — healthcare professionals — that your product or device is very useful for patients. So pharma companies and medical device manufacturers need more and more data, including for secondary usage, to analyze for R&D and improve their products and devices.

Why is health care data collection in European clinical trials so complex?

Navarro: Because it involves a lot of different actors and stakeholders with different interests: sponsors, contract research organizations, patients, investigators, sites, ethics committees, and national health care authorities. 

The sponsor is the entity benefitting from and paying for the trial, and that would be the pharma company or medical device manufacturer. You also have contracts with service providers that organize or monitor the clinical trials. 

And of course you have the patients, who are very important. In the key phases of the trials, they are suffering from the medical issue that is at stake here. You also have the investigators, who are the HCPs performing the clinical trials on each site — the sites being hospitals or private clinics. And everything is monitored by ethics communities, national health care authorities, and data protection authorities. 

Tell us more about how clinical trials are highly regulated.

Navarro: They are regulated by both the GDPR and each country’s national public health regulations, with rules and practices that vary from country to country.

This explains the variations that can exist among countries, even within the EU, despite on the supposed GDPR harmonization. But it doesn’t always work that way, because the GDPR provides a lot of opening clauses, giving flexibility to each EU member state to implement slightly different rules. Health care data is typically one area where each country has some flexibility. Plus, data collection and processing are also impacted by national public health regulations.

You mentioned that many of the actors involved have different roles under the GDPR. Please elaborate on that. 

Navarro: Under the GDPR, and from the point of view of EU data protection, each of these actors can be controllers, joint-controllers, processors, or recipients, depending on the country and the case. So the roles and responsibilities need to be well established before setting up any clinical trial.

Authorities also have concerns about the way sensitive data is handled, and about contact between patients and the companies producing the products or devices.

Navarro: Data collected during clinical trials is sensitive, and there’s always this concern from the authorities that the data can have value. Authorities are reluctant to regard very sensitive data as a commodity that could be exchanged and sold among various stakeholders.

Historically, contact between patients and pharma companies has always been a concern as well. We are in a field where we have different actors, but most of the time the patients are not the customers of the pharma companies or medical device manufacturers. Patients must receive proper medical treatment, and treatment is often reimbursed by national health care organizations and must be prescribed by health care professionals. 

The authorities refuse to imagine a case where a patient would be asking for one specific medical treatment. Treatment has to be prescribed by HCPs and it’s paid for, most of the time, in most EU countries, by a public or private health care organization. So the main concern is that the pharma companies should not advertise to patients. Of course, there is some exception where direct contact is possible. 

This is why pseudonymization, or de-identification, of patients is a widely accepted principle in all EU countries. A sponsor, meaning the pharma company or medical device manufacturer, will not get the names of the patients involved in a trial.

Explain more about why certain issues around data collection, clinical trials, and privacy are so highly debated. 

Navarro: One of the most disconcerting areas of divergence between EU member states is the different national positions on whether patient consent is a valid legal ground for processing personal data in clinical trials. 

Because clinical trials involve the use of “data concerning health,” the controller must cumulatively respect both the provisions of the GDPR’s Article 6, governing the basis on which data may be lawfully processed, and the conditions provided in Article 9, governing the processing of special categories of personal data, including data concerning health.

In most countries, pharma and medical device companies conducting clinical trials use patients’ consent as the legal basis to legitimize their data processing operations. Traditionally, to enroll and enter into a clinical trial, each patient or participant must accept and sign an informed consent form, where the protocol of the trial is explained and information about that protection is provided. And there is a consent granted by the patient.

But some authorities, like in the UK or the European Data Protection Board, are reluctant to accept consent as valid. This conclusion is based on the belief that patients are unable to freely give their consent in some trial situations, because the patient may fear he will not get access to medical treatment if he refuses. Or, in a case where the participant receives an indemnification for his participation. 

So we have to be careful. Consent is still a good legal basis in many cases and still seems to be the common practice. But it’s not always the case and has to be carefully considered, depending on the country where the clinical trial will take place. 

What are your key recommendations to protect health data? 

Navarro: Sponsors must be extra careful when they’re setting up the trials. They must integrate data protection rules and processes from the very beginning, as they will structure the way things are done. This includes integrating rules in the contract with the research organization, CRO, and in the clinical trial agreements, data privacy or data control agreements, and data processing agreements, where there could be a data privacy agreement that would be entered into with the sites and investigators.

The informed consent forms should also be carefully drafted to match both data protection rules and the reality of the data protection activities that will be done by the sponsor — the pharma company or device manufacturer. This should be sorted in advance and the variations between the countries where the trials take place must be taken into account early on. In some countries, the investigators and sites will almost always be processors, and in other countries they will be controllers or joint-controllers. This will have an impact early on, in all the contractual accommodations and on the way the trial is set up.

You also say that IT security is a high concern.

Navarro: Cybersecurity is something we should never overlook, of course, when we talk about data protection. Most of the big fines decided lately by authorities were about security. And here we are touching on something really sensitive. So cybersecutiy is a very high concern for all the actors, and when the sponsor is contracting to use what we call the eCRF — the database where all the clinical trial data will be input by the sites and investigators — security must be at the top of their priorities. 

Best practices around training are also an important factor of data processing.

Navarro: Yes. Some companies have a lot of clinical trials going on and are always in a rush because everything has to be done quickly to start clinical trials. So it’s very important that proper training is proposed to the clinical affairs team, any employee involved in clinical trials, and in the processing of the resulting data. Training is usually very efficient because in this industry we are talking to highly educated people who quickly understand the ins and outs of data protection rules. But the training has to be very practical, focused on the day-to-day issues and high-level principles, or it won’t be clear what to do with clinical trials.

My position is, we may be talking about a lot of contractual documentation, principles, and legal bodies, but all of these should never make us forget what is at stake here. The key point is to put ourselves in the shoes of the data subjects — the patients — and ensure that at any time we are protecting their rights and personal data. Compliance with the GDPR should not make us forget that the data subjects are always at the center. Sometimes we have to step back and look at things practically. It’s really basic: are we correctly protecting the subjects and their personal data?

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Hogan Lovells | Attorney Advertising

Written by:

Hogan Lovells

Hogan Lovells on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at:

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit
  • New Relic - For more information on New Relic cookies, please visit
  • Google Analytics - For more information on Google Analytics cookies, visit To opt-out of being tracked by Google Analytics across all websites visit This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at:

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.