There was a lot of debate surrounding the General Data Protection Regulation (GDPR) when it was approved by the European Union Parliament in April 2016 and came into effect in May 2018. However, most healthcare organizations eventually implemented the guidelines by making changes to their data governance and systems. So what is this concept of GDPR and how can it help protect the privacy and security of patients’ sensitive data? This blog aims to answer all of these and more.
What is GDPR?
The main objective of the GDPR was to protect the personal data of EU citizens and it is applicable to all companies operating or catering their products, services or monitor the behavior of the citizens in the EU. It replaced the Data Protection Directive which was in effect for many years. While technologies in healthcare have improved the lives of patients and made it easier for healthcare providers to offer diagnosis and treatment, the risk of data breach has also increased manifold. This law in fact gave individuals the power and control over their personal data so it is not used by anyone without their consent.
Also despite adhering to the GDPR norms if data breach still happens, then according to the regulations, healthcare providers are required to notify about it to the relevant supervising authority within 72 hours. The individual’s whose information has been breached should also be intimated If the breach is likely to impact the said person’s rights and freedom.
Why is GDPR applicable to healthcare?
As per GDPR guidelines, healthcare data comes under the special category and hence healthcare organizations are required to implement rigorous protection framework than the rest others. The regulation has defined three types of personal data in healthcare: :
- Healthcare data, which includes any information related to an individual’s physical or mental health such as the type of treatment the patient received.
- Genetic data, which contains information related to an individual’s genetic makeup.
- Biometric data, which includes data such as facial images and fingerprints or any other physical or behavioral characteristics.
Legal Basis for Processing Health Data
GDPR does not allow processing of health data unless certain conditions are met. This includes:
- Explicit Consent: If individuals have given consent to collect, process and use their personal data for specific purposes, then it is termed as the explicit consent.
- Healthcare Provision: At times, especially during medical emergencies, processing of personal data is necessary for medical diagnosis. In such scenarios, data can be processed.
- Public Interest: Data processed for the greater public interest such as ensuring safety of medical products or devices falls under this category.
Rights of Individuals under GDPR
Individuals have been granted following right under the GDPR:
- Right to access their personal data.
- Right to rectify wrong or incomplete data.
- Right to be forgotten, which means individuals can request to delete their data under certain conditions.
- Right to restrict the processing of their data.
- Right to request the transfer of their data to another data controller.
- Right to object to the processing of their data in certain circumstances.
What are the Challenges that Healthcare Providers Face when Implementing GDPR?
The vast volume of complex data makes compliance difficult, especially when sharing across different systems. Gaining consent can also be troublesome when processing data in emergency situations.
Steps to Ensure GDPR Compliance
- Healthcare providers are required to establish robust data governance frameworks to ensure compliance with GDPR.
- A Data Protection Officer (DPO) should be appointed, who would oversee data protection strategies.
- Appropriate measures such as encryption, access controls etc, should be implemented to protect data from breaches, unauthorized access or damage.
- Staff training should be conducted on a regular basis to ensure they understand their responsibilities under GDPR.
- Regular audits and updates should also be conducted to identify potential lapses or risks in data protection practices.
Data Minimization and GDPR Compliance
One important thing with respect to GDPR that most tend to miss out is the principle of data minimization. According to this principle, healthcare organizations should only collect and process the minimum amount of personal data which is necessary to achieve their intended objectives. This means healthcare providers can only collect data pertaining to a patient’s care and treatment should be collected.
However, having said that, implementing data minimization can actually be challenging, especially in healthcare settings where comprehensive data collection may become necessary for providing treatment.
The intent of this principle is to focus only on gathering data that is necessary, putting emphasis on privacy and limiting the amount of sensitive information at risk. As a next step to achieve effective data minimization, organizations must review their data practices and if necessary upgrade them.
Integrating Data Protection Impact Assessments (DPIAs) into Healthcare Data Management
Data Protection Impact Assessments (DPIAs) help organizations identify and address privacy risks associated with processing information such as medical records, genetic data, and biometric data. DPIAs is a structured approach which ensures that data protection measures are integral to healthcare operations.
If an organization is implementing a new IT in healthcare process, such as electronic health record (EHR) systems, telemedicine platforms, or healthcare data analytics tools, it’s essential to conduct a DPIA. These technologies often involve processing large volumes of sensitive patient information, which makes it necessary to check how they impact data privacy.
Similarly, if an organization is involved in large-scale data processing, such as data mining for research or public health monitoring, a DPIA is important to assess and manage privacy risks associated with handling extensive patient data.
Steps to Conduct a DPIA in Healthcare:
To conduct an DPIA, one needs to start by identifying and documenting all data processing activities. This includes understanding what types of patient data are being processed, the purposes for processing this data, and the methods used for collection, storage, and usage.
Next is to assess whether these processing activities are necessary and proportional to the intended objectives. It’s also crucial to identify potential risks to patient privacy and data security. This involves evaluating the likelihood and impact of risks like unauthorized access, data breaches, or misuse of data.
After identifying these risks, develop and implement strategies to mitigate them such as employing robust data encryption, stringent access controls, secure storage solutions, and regular security audits. Finally, the DPIA process should be documented and regular reviews and updates should be carried out.
The Impact of GDPR on Global Healthcare
Some believe that organizations operating in regions other than the EU are not required to adhere to GDPR. However, it is not true. Any organization providing their products or services to the EU citizens are required to abide by the GDPR policies. Hence it is obligatory for healthcare organizations across the world to comply with GDPR by upgrading their data management policies.
Irrespective of the debate or criticism it received, the fact is GDPR has changed the way healthcare data is stored, managed and processed. Hence compliance with it not only helps to prevent fines but also safeguard data from cyber threats. It ensures patients that their sensitive health information is protected.
What are the Best Practices for Data Security in Healthcare?
Healthcare organizations are often on the radar of the hackers and cyber criminals due to the sensitive nature of data they possess. Ransomware, phishing, and data breaches can leave a detrimental effect on both patients and healthcare providers. Hence, GDPR has made it mandatory to implement reliable data protection methods to protect personal data.
Some data security measures that can be adopted are:
- Using firewalls and anti malware solutions to protect networks and devices from malicious attacks.
- Installing Breach Detection Systems (BDS) for monitoring, detecting and responding to any potential breaches quickly and efficiently.
- Encryption Technologies ensure that data is encrypted to prevent any unauthorized access.
Apart from the above measures, healthcare organizations also need to implement internationally recognized cyber security frameworks that align with GDPR standards to protect healthcare data.
The growing threat to supply chain networks can be mitigated by regularly performing regular risk assessments and conducting thorough background verifications of staff entrusted with the responsibility of accessing sensitive data.
Conclusion
GDPR through its stringent policies has placed patients at the center of care. It has given patients the power to determine if they want healthcare organizations to process their data. Looking at the other side of the coin, meeting the legal and ethical obligations under GDPR has also made healthcare organizations pay more attention to their patients’ data security and build trust among patients.
FAQs
1. What is GDPR and why is it important for healthcare organizations?
The General Data Protection Regulation (GDPR) is a data protection law passed by the parliament of the European Union in April 2016 and enforced from May 2018. It is a crucial law for healthcare organizations because it has made it mandatory for healthcare providers to safeguard healthcare data to ensure patient privacy. Moreover, it gives individuals greater control over their own data.
2. What types of healthcare data are protected under GDPR?
GDPR protects three main types of healthcare data: (1) Healthcare Data, which comprises any data that is related to an individual’s physical or mental health, (2) Genetic Data, containing information about an individual’s genetic makeup, and (3) Biometric Data such as facial images or fingerprints that can reveal a person’s identity.
3. How to report data breaches under GDPR?
Under GDPR, if a data breach occurs, healthcare organizations must notify the relevant supervising authority within 72 hours. The affected individuals should also be informed, if the breach impacts their rights and freedoms.
4. What are the legal bases for processing health data under GDPR?
Health data can be processed under GDPR if healthcare organizations have explicit consent from individuals, if data processing is necessary in case of emergencies such as for medical diagnosis or treatment, or for safety of the public such as if it’s related to medical safety or research.
5. Does GDPR apply to organizations outside the EU?
Yes, an organization based in any part of the world that offer products or services to EU citizens or engaged in monitoring their behavior must comply with GDPR.
