By Michiel Van Roey, Intellectual Property and Technology Lawyer from Stibbe, Brussels
By adopting the new data protection regulation on April 14, 2016, the European institutions have decided to set up a new legal framework to enhance the protection of personal data. One of the key points of this new framework concerns the processing of health data. Because health-related information is very sensitive in nature, and the use thereof can have an adverse effect on a person’s private life and reputation, the regulation imposes a higher standard of protection for the processing of health data. This higher standard, aimed at protecting the fundamental rights and privacy of patients, results in a higher burden on the professionals in the health sector who will have to find their way through these rules to comply with their obligations.
As a general rule, professionals in the health sector – doctors, pharmacists, nurses, healthcare insurers, and other healthcare service-providers – are prohibited from ‘processing’ health data about their patients unless they have obtained the explicit and informed consent of the patient to do so or unless it is done under specific circumstances set out in the law. Therefore, healthcare professionals are in principle not allowed to collect, record, store, alter, use or disclose any “information which relates to the physical or mental health of an individual, or to the provision of health services to the individual” without the patient’s consent. This can include anything from medical records, examination results, medical history, a disease or a person’s psychological state.
One of the circumstances under which health data can be processed even without the explicit consent of the patient, however, is when a healthcare professional who is subject to a legal obligation of professional secrecy or a similar obligation of confidentiality, such as a doctor, nurse or pharmacist, needs to collect, store or use health data, or needs to communicate with another healthcare professional, for health-related purposes (e.g. medical diagnosis, provision of care, or treatment) of the patient in question.
The regulation also allows the processing of health data for reasons of public interest in the area of public health, such as protecting against serious cross-border threats. There can indeed be situations in which sensitive health data of a patient need to be communicated to certain authorities so that the right measures can be taken to protect the citizens. This could be the case when tracing the contacts of an infected person in order to prevent the (further) spread of a contagious disease, such as ebola or tuberculosis, is done with the higher goal of the public interest in mind.
Considering the sensitive nature of health information, it is imperative that professionals in the health sector who work with or use this type of information (“data controllers”) are aware of their legal responsibilities under the new regulation, and the patients or people whose data are being processed (“data subjects”) are aware of their rights. Data controllers have, for instance, the obligation to secure health data that are under their control and notify the authorities of any data breaches. This means that every doctor has to take the appropriate security measures to make sure his/her patients’ health data are kept secure. He/She can do so by, for example, securing his/her personal computer with private logins and passwords and by installing firewall updates and antivirus software on his/her computer. If the personal computer or hard drive onto which patients’ records are saved is stolen or is unrightfully accessed through the internet, the regulation obliges medical practitioners to notify this “data breach” to the competent national protection authority within 72 hours from when he/she became aware of it.
Further, when processing health data, the data controller – for example, a doctor – has a number of obligations to fulfill. He/She must not only inform the data subject about the specific purpose for which information about his/her health is collected or used, but also allow the data subject to exercise his/her rights to (access or change) this information, free of charge. For instance, a patient is entitled to receive a free copy of his/her medical records containing information such as diagnosis and examination results. Additionally, a patient has the right to obtain from his/her doctor the correction of any inaccurate information about his/her health, and, in certain cases, he/she also has the right to object to the processing or use of his/her health data and even the right to have some data about his/her health situation removed from the file.
The cloud doctor
Health professionals are increasingly tempted to keep medical records of their patients on servers connected to the internet or in the ‘cloud’, and not merely on paper files. Hence, the risk of data being unrightfully accessed becomes bigger. By the same token, data breaches are even more likely to happen, and health data are more likely to be stolen. The cloud is indeed not always the safest place to store such data, as evidenced by the numerous data leaks making news headlines these days. Also, if the cloud infrastructure used is located outside the EU, the data are effectively exported outside the EU thereby triggering additional concerns and conditions. Therefore, if cloud-service providers seek to convince the health industry of the benefits that the cloud could offer, they should offer state-of-the-art security or at least inform medical practitioners of the existing security levels that are in place and where the data will reside physically.
Even if the security of health data might be more at risk if they are stored in the cloud, the government is taking steps towards a more ‘connected’ health system. The Belgian Government recently put forth its e-health initiative (www.ehealth.fgov.be), which is a ‘cloud’ platform focused on the exchange of patients’ health information by healthcare professionals. The data on this platform may be accessed by doctors, hospitals and other healthcare providers throughout the country, and not only by the treating doctor.
Finally, it is not only the medical practitioner but also the cloud service provider that will have direct legal obligations and responsibilities under the new regulation, including the security and breach notification obligations. This seems more than logical as the latter is effectively conducting the ‘processing’ of the health data while the doctor, for his/her part, has no control on the actual technical security measures that are implemented on the external data storage servers of this cloud storage service provider. It will therefore not only be the professionals in the sectors but also the cloud service providers that need to step up in order to offer more secure data storage.
The regulation can be accessed here. It will enter into force 20 days after its publication in the EU Official Journal. Its provisions will be directly applicable in all Member States two years after this date of publication.
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