Watch the ERP systems compliance and validation webinar!

Go to Webinar
(312) 207-5800

What is GDPR?

General Data Protection Regulation (GDPR) is a European Union law that regulates the data protection and privacy of citizens in the European Union (EU) and the European Economic Area (EEA). GDPR represents one of the highest standards of data protection in the world.  The goal is for individuals to have greater control of their sensitive information and requires organizations to handle data responsibly. GDPR replaced the Data Protection Directive and is applied to all EU member states and international organizations that process EU resident data. GDPR addresses personal data transfers outside the EU and EEA.

Data privacy is data handling within legal and standard requirements involving consent and regulatory expectations. GDPR has critical principles to assist organizations in addressing data privacy concerns. Data privacy and protection can be maintained with transparency, set limits, data minimization, limits on storage, accuracy, security maintenance, and accountability.  GDPR consulting ensures all departments handling personal data comply with GDPR law and address all data principles. 

GDPR’s Role in the EU and EEA

GDPR’s crucial role in the EU and EEA establishes a unified framework for protecting personal data. Data integrity compliance applies to data controllers or processors established in the EU and those who offer goods or services to (or otherwise collect data on) individuals in the EU. US organizations that collect or process data of EU individuals are also in scope for GDPR. GDPR influence results in a high standard for personal data protection, assisting individuals with increased control over how their data is collected, processed, and stored. GDPR creates a consistent set of rules for operating within the EU and EEA by harmonizing EU data protection laws and simplifying data integrity services for organizations operating across multiple EU countries.

The Pillars of GDPR

GDPR is a comprehensive data privacy regulation designed to protect citizens with foundational data protection principles.

Transparency: Personal data is processed fairly, lawfully, and transparently. The processing of personal data is clear and understandable to individual users.

Data Minimization: To avoid unnecessary collection of personal data, only the minimum amount of data is collected and processed.

Storage Limitation: Personal data should not be retained when it is no longer required for legitimate and reasonable business purposes or legal reasons.

Accuracy: Personal data is kept up to date when necessary and must be accurate. Set measures ensure inaccurate and outdated data is fixed or erased.

Security: Processing personal data should include protection against unauthorized processing, accidental loss, and destruction of personal data.

Accountability: Organizations controlling personal data are responsible for meeting GDPR requirements and must demonstrate compliance.

Data Subject Rights: GDPR provides data subjects (individuals) various rights concerning their personal data, such as the right to correction, the right to erasure, and so on.

Data Inventorying: GDPR requires mandatory data inventorying and record keeping of all internal and third-party processing of personal data.

The Evolution of Health Data

Technological advancements in health data collection have transformed the healthcare industry, revolutionizing personal medicine, improving patient care, and enhancing research capabilities. Technology advances can transform healthcare by progressing data access, efficiency, and accuracy, leading to better informed medical decisions and patient outcomes. Technological developments like wearable devices, mobile health applications, and remote patient monitoring also raise data security, ethical use, and privacy considerations.

The Health Insurance Portability and Accountability Act (HIPAA), ISO 27701, and the General Data Protection Regulation (GDPR) impact how health data is regulated. HIPAA focuses on healthcare data in the US, while ISO 27701 (Privacy Information Management System) provides a framework for privacy management systems, both addressing considerations related to data protection and privacy like GDPR. HIPAA establishes standards for the use and disclosure of protected health information (PHI) with an implementation of security measures to safeguard the information. PHI pertains to the collection, storage, and use of personal data and addresses personal information accessibility and under what conditions.

ISO 27701 helps organizations establish processes for managing personal information, including implementing controls for protecting privacy rights and ensuring compliance with applicable privacy laws. ISO 27701 aligns with GDPR, and organizations can implement it as a tool to demonstrate compliance with GDPR’s aspects of privacy. It includes specific guidance on integrating GDPR requirements into an organization’s privacy management framework. While HIPAA, ISO 27701, and GDPR are distinct frameworks, they share common goals of protecting personal information and ensuring responsible data handling. Implementing ISO 27701 can help demonstrate compliance with ISO standards and GDPR requirements.

Challenges in Data Privacy

GDPR significantly changed how organizations handle personal data and enhancing privacy rights further challenges life science organizations in a complex regulatory landscape. Navigating regulations requires a thorough understanding of legal requirements and demands an ongoing effort to stay updated on regulatory changes. Identifying and mapping personal data creates the challenge of maintaining a comprehensive inventory of the personal data they process, including where it originates, how it’s used, and where it is stored. New storage methods and sharing data have created gaps in regulatory frameworks, potentially exposing PHI to malicious exploitation. GDPR mandates the implementation of security measures to protect personal data to ensure data security and promptly notify relevant authorities and data subjects in the event of a data breach is logistically and operationally challenging.

Addressing data privacy challenges requires a holistic approach to data governance, including training and education, robust data protection policies, and integrating privacy considerations into organizational processes and systems. Organizations must proactively address these data protection challenges to demonstrate GDPR compliance with GDPR and protect the privacy rights of individuals.

Arbour Group’s Data Privacy and GDPR Compliance Services

At Arbour Group, whether it is an Assessment and Gap Identification, Data Strategy, Gap Remediation, Data Security Design and Implementation, or setting up an end-to-end GDPR program, we can help you achieve your Data Privacy and GDPR Compliance service goals.  Our expert methods can help you make greater use of encryption and other techniques for data security, like using pseudonymization or anonymization where appropriate.  

Assessment and Gap Identification: Achieving GDPR compliance involves a risk assessment of an organization’s data processes, policies, and procedures to ensure they correspond with GDPR requirements. A GDPR assessment may include data inventory and mapping of all personal data processed, a legal risk assessment of GDPR requirements, establishing consent management mechanisms, and conducting a Data Protection Impact Assessment (DPIA) for high-risk activities to understand the impact on data privacy. Gap identification involves reviewing an organization’s data protection practices to compare them to GDPR requirements.

Data Strategy Formulation: A comprehensive plan that outlines an organization’s data management, processes, and protection following GDPR requirements. An organization must meet legal obligations and safeguard individual privacy rights by implementing data governance, compliance standards, and risk management. A concise data strategy plan is essential in navigating the complex data protection landscape of data integrity services, providing a roadmap to help mitigate risks and is updated to ensure cohesion with evolving regulatory requirements.

Gap Remediation: After identifying gaps in an organization’s data protection practices compared to GDPR requirements, a gap remediation plan implements measures to remedy deficiencies to achieve GDPR compliance. Systematically monitoring the gap remediation plan is necessary to ensure ongoing compliance as organizations grow and the regulatory landscape evolves.  

Data Security Design and Implementation: Incorporating a security strategy in an organization’s systems, processes, and infrastructure protects processes centered around personal data. Similar considerations should also be applied to systems hosted by third parties and where the security responsibility may be shared. Data security must be designed to meet GDPR requirements by ensuring the integrity, privacy, and accessibility of personal data. Data encryption is implemented to protect personal data during transmission and storage to prevent unauthorized access. Pseudonymization replaces direct identifiers with artificial identifiers to reduce the risk of re-identification. These examples of design measures can enhance data security with data integrity consulting and align an organization with GDPR consulting requirements.  

Contact us today for more information on Arbour Group’s Data Privacy and GDPR Data Integrity Compliance Services.