Data is the new currency. That is why the privacy and protection of data are of utmost importance. Healthcare organizations, in particular, have a higher reliance on personal data than any other sector.

Although healthcare has always been required to comply with numerous privacy regulations, a lot was still left to be desired. So, it was on 25th May 2018 that the European Union’s (EU’s) General Data Protection Regulation (GDPR) came into effect.

There was already a well-managed set of regulations under the Health Insurance Portability and Accountability Act (HIPAA) in the United States. But for the rest of the world, there were a lot of overlapping governance frameworks. This was resolved after GDPR was launched. 

GDPR aims to achieve regulatory consolidation, better clarity, and improved jurisdiction. It is the EU’s digital privacy legislation. This set of laws affects how organizations store, collect, and transmit personal data of EU residents and citizens, thus giving them control of their personal data. 

The GDPR not only applies within the EU but also to organizations outside the EU that offer services to EU citizens. Due to the ever-expanding globalization, personal data is being stored in servers all across the globe. Hence, GDPR has a global scope.

As per the GDPR guidelines, organizations can be given a maximum penalty of $24 million or 4% of the annual revenue of the violator. This means any organization can be affected monumentally if they don’t comply with GDPR.

Talking about the healthcare sector, it is the industry that is least ready for GDPR. As per a survey, only 17% of healthcare organizations have systems in place to address the GDPR. And since healthcare organizations handle a significant amount of personal data, the GDPR becomes even more important for the healthcare sector. 

In this article, we’ll try to understand GDPR and its role in healthcare.

What is GDPR?

As discussed earlier, GDPR is a set of guidelines offered by the EU that aim to protect the personal data of EU citizens.

Essentially, GDPR empowers EU citizens to have expanded control over their personal data. Some key traits of GDPR are:

  • GDPR defines personally identifiable information or personal data as any kind of information that can be used to identify a person, be that identification number, name, location data, or identifier number.
  • GDPR dictates how organizations process, hold, or use data related to EU citizens, whether the organization is in the EU or outside the EU.
  • GDPR can result in entities being fined up to 4% of their annual global revenue in case they do not comply with the defined regulations.

Key regulations under GDPR

You can read the entire regulations here. However, in order to avoid reading 88 pages of legal documentation, we have covered some of the key points here – 

  • EU citizens should give their consent to the organizations to allow them to collect personal data.
  • Organizations clearly need to mention how and why they are processing user data.
  • Information like IP address and biometric data is also included under personal data.
  • As per GDPR, users can submit requests to access their data, and the companies are obliged to respond to such requests within 30 days.
  • There is also a clause about the ‘right to be forgotten.’ This means the users can request their data to be deleted.
  • GPDR also empowers EU citizens to allow the withdrawal of their consent for future data collection.
  • Those collecting user data must fulfill all GDPR requirements. They must also maintain records of data collection.
  • Organizations are required to report a data breach within 72 hours of discovering it.
  • Some entities might be required to appoint a data protection officer.

What is GDPR compliance?

As per the regulations under GDPR, organizations need to comply with data collection norms. There are strict conditions laid out for the legal gathering of data.

Moreover, the collected data must be protected from misuse and exploitation. Organizations also need to respect the rights of data owners. Failing to comply with the GDPR might cause these organizations to face penalties.

GDPR for the healthcare sector

Even though GDPR offers challenges for all industries, the healthcare sector is specifically affected. The GDPR categorizes collected data as –

  • Personal data: It includes any information related to an identified or identifiable individual like identification number, location, or an online identifier.
  • Health data: It includes ‘data concerning health’ (related to the physical or mental health of a person), ‘genetic data’ (related to inherited genetic characteristics), and ‘biometric data’ (related to technical processing of physical or physiological characteristics).

The regulations for personal data are already strict enough, like including consent. But when it comes to health data, the standards are even higher. 

To process health data, an organization must meet one of the following three conditions:

  • The healthcare organization must have taken ‘explicit consent’ from the person.
  • The organization needs to process health data for preventive or occupational medicine.
  • The processing of health data is essential for reasons of public interest in the public health domain.

Steps to be taken by healthcare for GDPR compliance

Healthcare organizations should be proactive in trying to comply with the specific regulations shared above. Moreover, they must take the following steps towards GDPR compliance –

  • Review contracts like Data Processing Agreements.
  • Update policies, procedures, documentation, and records in order to prepare themselves for inspections.
  • Maintain data processing activity records, including data deletion or retention periods.
  • Install technical security measures to avoid any cyber-attacks, unauthorized access, or loss of health data.

By its very nature, the healthcare sector collects a lot of personal data. GDPR helped push organizations towards stringent measures for data protection and user privacy. However, as discussed earlier, a large chunk of organizations still lack systems to comply with GDPR. Deeper progress can only be made when organizations fundamentally prioritize data privacy and digital security. Only then can personal data be protected.