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Navigating international data collection for patient organizations
Con Hennessy, Senior Director and General Manager, IQVIA
Brian Kerr, Business Development Manager, IQVIA
May 15, 2025

Patient organizations in the United States, particularly those focused on rare diseases, often seek international data collection to gain a comprehensive understanding of the patient population.

Collecting data from patients outside the U.S. involves more than simply inviting global participation into your registry. Handling international data, especially protected health information, involves several challenges:

  1. Navigating complex regulations: Different countries have their own data protection laws, such as General Data Protection Regulation in the European Union, Health Insurance Portability and Accountability Act, and California Consumer Privacy Act in the U.S. These regulations often have varying requirements for data handling, consent, and breach notifications, making compliance a complex task.
  2. Addressing privacy concerns: Ensuring patient privacy is paramount. Organizations must implement robust security measures to protect personally identifiable information and PHI from unauthorized access and breaches. This includes encryption, access controls, and regular security audits.
  3. Meeting legal requirements: Legal requirements can vary significantly between countries. For example, some countries may require data localization, meaning data must be stored within the country’s borders. Organizations must be aware of and comply with these legal mandates to avoid penalties.
  4. Data sharing: There are notable differences between patient-entered data and clinician-released patient information:
    • Patient-entered data: When patients enter their own data, they have direct control over what information is shared and with whom. Legal requirements for patient-entered data often focus on ensuring that patients are fully informed about how their data will be used and that they provide explicit consent. HIPPA and GDPR mandate that patients must be able to access their own health information and have the right to correct inaccuracies.
    • Clinician-released patient information: When clinicians release patient information, the legal requirements are more stringent. Clinicians must ensure that any disclosure of PHI complies with privacy regulations and is limited to the minimum necessary information. HIPAA, for example, requires covered entities to implement safeguards to protect PHI and to obtain patient authorization before releasing information, except in specific circumstances such as treatment, payment, or healthcare operations. Additionally, clinicians must adhere to state-specific laws and regulations that may impose further restrictions on data sharing.
  5. Managing consent: Obtaining and managing patient consent is crucial. Consent must be informed, explicit, and revocable. Organizations need systems in place to track and manage consent, ensuring that patients can easily withdraw their consent if they choose. Using good ethical practices involves clearly informing patients about what will be done with their data and asking for their consent. This approach aligns with the principles of Good Clinical Practice, which emphasize the importance of patient autonomy and ethical conduct in clinical trials. Ethical consent management includes transparency, voluntary participation, revocability, and compliance with regulations.
  6. Data residency: The location where data is stored can impact compliance. Some regulations require that data be stored within specific geographic locations. Organizations must ensure that their data storage solutions comply with these requirements and that data is securely stored and accessible only to authorized personnel.

These challenges require a comprehensive approach to data governance, security, and compliance to ensure that international data collection and handling are conducted responsibly and legally.

To overcome these obstacles, patient organizations need a well-governed and trusted platform that facilitates the easy entry and collection of clinical data from patients around the world in an organized, understandable, and controlled manner.

Benefits of international data collection

As registries have evolved to capture more types of patient data, their complexity has grown. Initially focused on basic population-health data, registries have expanded to include detailed information on diagnoses, treatments, outcomes, and symptoms. This broader scope has made the data collected by registries increasingly valuable to researchers.

This is particularly true for rare diseases, which affect a small number of patients, making international data essential for drawing meaningful conclusions. Developing drugs, biologics, and devices for rare diseases is challenging due to the complex biology and limited understanding of the natural history of many of these conditions. Additionally, the small patient populations make it difficult to conduct clinical trials.

Expanding their patient bases globally allows patient organizations to gain deeper insights into longitudinal trends related to rare diseases and compare outcomes and treatments across different regions. This analysis can sometimes uncover insights from one country that can be applied to another, ultimately helping to improve the quality of life for patients worldwide.

The value of international data collection extends beyond rare diseases. By collecting data from multiple countries, registries can examine geographic variations in disease origin progression, and treatment patterns. This broader dataset allows for more comprehensive research and a better understanding of diseases across different populations.

Multi-national registries can help meet regulatory requirements in various countries. For example, in Europe, registries designed to meet post-marketing requirements for products approved by the European Medicines Agency are often multi-national. This approach ensures that the registry provides country-specific information about where the product is used.

Data from international registries can inform and improve clinical practices by highlighting effective treatments and interventions used in different regions. This can lead to the adoption of best practices globally. Collecting health economic data from multiple countries can inform health technology assessments and reimbursement decisions, which is particularly important for understanding the cost-effectiveness of treatments in different healthcare systems.

For diseases that are not rare but still require large datasets for meaningful analysis, international registries can enroll larger numbers of patients. This enhances the capacity to detect adverse events and understand the efficacy and safety of interventions in diverse populations.

Data sharing: Aggregated data vs. raw data

Once data has been collected, efficient, effective, and safe mechanisms need to be in place to share data allowing research to be performed safely.

When sharing data, there are important differences between aggregated data and raw data:

Aggregated data: This type of data is summarized and combined from multiple sources, providing an overview without revealing individual-level details. Aggregated data is useful for identifying trends, making comparisons, and ensuring privacy, as it reduces the risk of reidentifying individuals. It is often used in public reports and research publications to present general findings.

Raw data: This is the original, unprocessed data collected directly from sources. Raw data contains detailed and specific information, making it valuable for in-depth analysis and research. However, it requires more stringent security measures to protect privacy and is typically shared under strict conditions to ensure compliance with data protection regulations.

Overall, international data collection in registries provides a more comprehensive understanding of diseases, supports regulatory compliance, improves clinical practices, and informs health economic decisions.

IQVIA’s suite of registry solutions

To aid these initiatives, IQVIA’s suite of registry solutions are at the leading edge of privacy protection while enabling secure research in an auditable, standards compliant approach. Patient organizations retain complete ownership and control over all the data collected, ensuring it remains secure and exclusively theirs. Additionally, the suite of registry solutions can accommodate data directly from clinical users using clinically reported modules to combine both clinical and patient-reported data.

IQVIA’s suite of registry solutions offer patient organizations international data collection, enabling both research studies and longitudinal research. Solutions can be fully managed, cloud-based, and are highly scalable and customizable. Designed to easily adapt to future requirements, the suite is built with robust data security measures to ensure privacy that align with GDPR and Health Insurance Portability and HIPAA regulations.

To learn more about IQVIA’s suite of registry solutions, contact us at ppa-contact@iqvia.com.

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