Efficient Clinical Data Privacy Solutions for Trials

The importance of Clinical Data Privacy

Promoting health and well-being of patients globally requires rigorous clinical trial procedures for any new medical product or the utilization of existing technologies in different ways. Every medical organization bears both moral and legal responsibilities to shield protected health information (PHI) from potential malicious actors.

The motivations behind unauthorized attempts to gather patient medical data can range from profit-driven motives to ransom-related activities. Implementing sound data privacy practices is paramount for medical organizations, not only to protect the personal health information of their clients and patients but also to fortify their systems against unwarranted digital intrusions.

Ensure compliance and protect patient privacy with our efficient Clinical Data Privacy solutions. Our experienced team will work with you to design and execute a data privacy plan tailored to your trial. Keep reading to learn more.

Clinical Data Privacy Laws

The evolution of data privacy in healthcare spans over 130 years, with recent milestones like the U.S. HIPAA standards and the groundbreaking GDPR, reflecting the increasing importance of safeguarding patient and participant data in an era of advancing technology.

Privacy laws, like HIPAA and GDPR, aim to protect individuals’ right to privacy and secure information that could identify them.
HIPAA safeguards individually identifiable health information in the U.S., while GDPR, originally for EU individuals, has become a global standard.
Personal data includes any information, even seemingly innocuous identifiers, that, when combined, may unveil an individual’s identity.

Personal Clinical Data Privacy Concepts

As clinical trials embrace remote technologies, understanding three fundamental concepts becomes crucial for organizations navigating the intricate landscape of data privacy:

Notice: Informing individuals (data subjects) about how their personal data is processed and protected is mandatory, conveyed through consent forms, privacy policies, and other notices.
Permission: Obtaining lawful permission is essential before collecting or using personal data. GDPR provides a robust framework, outlining six lawful bases, including consent, contract, legitimate interests, legal obligations, vital interests, and public interest.
Choice: Individuals must have the opportunity to exercise their rights outlined in privacy laws, such as submitting Data Subject Access Requests (DSAR) under GDPR.

But there are also some challenges

Data Privacy Laws, primarily shaped by GDPR in the EEA and HIPAA in the U.S., create a complex landscape for clinical trials globally. As the privacy framework rapidly evolves, laws impose obligations similar to GDPR, but U.S. state laws generally exempt data collected under HIPAA, particularly in clinical trials. This creates challenges and considerations in three critical areas: (1) defining roles and responsibilities, (2) navigating cross-border transfers of Personal Data, and (3) addressing the complicated reality of notice requirements.

Defining Roles and Responsibilities

HIPAA governs U.S. clinical studies, requiring compliance from institutions, but sponsors, not typically “covered entities,” must carefully ensure HIPAA adherence.
GDPR applies universally in the EEA, demanding a nuanced assessment of roles (controller, processor) for each party involved in clinical research.
Clear role definitions are crucial at the trial outset to navigate obligations and protect data subjects effectively.

Cross-border Transfers of Personal Data

GDPR restricts Personal Data transfer outside the EEA, necessitating adequate protection, commonly achieved through European Commission standard contractual clauses (SCCs).
Challenges arise due to the complexities of the U.S.-EEA Data Protection Framework, potential limitations for nonprofit organizations, and issues related to the application of SCCs for data importers subject to GDPR.

Complications in Notice Requirements

GDPR’s Fair Processing Information requirement, central to data protections, faces difficulties in clinical trials where meaningful research often involves secondary data uses.

Challenges emerge when personal data is not directly collected from subjects or is pseudonymized, hindering genuine notice and (re)consent.
The industry seeks an updated solution to balance Personal Data protection and facilitate vital medical research, acknowledging the value of data in clinical research and the intricate regulatory landscape.

In the complex realm of clinical research, understanding applicable laws, defining roles, addressing cross-border data challenges, and navigating notice complexities are important for all involved parties to secure and use data responsibly.

Trust ECLEVAR for your Clinical Data Privacy and Management

The intricate process of bringing innovative solutions to the market involves various crucial activities, and one such key component is Clinical Data Management (CDM). CDM plays a pivotal role in gathering, interpreting, and statistically analysing robust data obtained from trials. Its primary objective is to minimize the time between product development and market availability while adhering to regulatory standards. CDM is actively engaged throughout all stages of a clinical trial.

Many roles are included in CDM activities, they are assessed for quality, at regular intervals, during a trial:

Data Managing
Database Programming
Design
Medical Code
Clinical Data Coordinating
Quality Control
Data Entry

CDM has a critical significance in the success of clinical trials, so these activities must be conducted by skilled specialists. ECLEVAR, as an experienced Contract Research Organization (CRO), possesses extensive expertise in regulatory compliance and the efficient execution of clinical trials. Our dedicated team is well-equipped to address your specific research, data, and documentation requirements, bringing your product closer to target markets. We are unwaveringly committed to ensuring the verification and protection of access to the collected data, aligning with our rigorous Protection & Privacy Policy.