Patient privacy and trust are two of the most critical aspects of any clinical trial’s success – patients must understand and feel confident in the protocols designed to protect their sensitive health information. Because patient privacy is such an incredibly important issue, governments across states and countries have differing ideas on how to best protect it. Given the free-flowing nature of digital data, it begs the question of whether geographic borders are really the best parameters for data regulations – the very laws that aim to unequivocally secure patient health information (PHI) are the same that can contribute to a fragmented maze of regulations and ultimately hamper research efficiency, patient trust and participation in clinical trials. If the U.S. defined federal data privacy laws, or if globally agreed-upon standards were created, it would offer researchers a clearer framework to build their studies around and serve as a consistent foundation to foster patient trust.
Patient Privacy Law as Governed by Zip Code
The various data privacy requirements across the country and world means the PHI collected in trials is different based on where that trial took place, limiting population-wide analyses. At the moment, US researchers must handle patient data privacy on a case-by-case basis, per each individual study, using precious time and resources to ensure they are meeting the standards of the state where the study is taking place. Outside of the US, standards governing data privacy do exist, such as the European Union’s General Data Protection Regulation (GDPR). The GDPR is renowned for heavily governing the usage of personal data, and while it is very strict, researchers in the EU benefit from having consistent standards to help shape their studies.
The absence of uniform privacy regulations in the US has profound impacts on both scientists and patients in clinical studies. Researchers end up spending precious hours poring over their jurisdictions’ regulations to make sure they know what protections to outline in consent forms, and patients typically aren’t aware of their personal protections which can lead to mistrust of how pharmaceutical companies will use their sensitive health information. With the implementation of clear, concise federal laws that are easy for citizens to understand, both researchers and trial participants alike will know what to expect from protections and will have confidence in the system.
Bolstering Diverse Data Sets
Citizens have a right to be skeptical about a certain level of surveillance, as personal data, especially health information, in the wrong hands could be detrimental. Consistent federal standards around personal data usage could help boost the general populations’ trust in the medical field, especially among minorities who may be weary of participating in clinical studies. Typically, those that have historically had the most privacy concerns are the populations that are most likely to be underrepresented in medical research. While warranted, higher rates of skepticism can lead to an unfortunate vicious cycle – by not participating in clinical trials, resulting treatments will not be as precise in all patients, and mistrust will continue.
Just as there is a growing movement against bias in AI, it is critical to ensure that similar biases do not seep into clinical trial results. Beyond distrust, the level of diversity in a clinical trial also influences the reliability, accuracy and inclusivity of its data, and one’s ability to prove a drug’s validity in the real world – what looks highly accurate in research could negatively impact underrepresented groups outside of a controlled environment. Having those from diverse backgrounds contribute to medical research is the only way real-world outcomes for these populations can improve and the effects of clinical research to be felt as widely as possible.
In order to boost trust and extend the life of PHI for future use, de-identification technology is a welcome step forward. When going through confidentiality agreements for future use of patient data, researchers should explain guidelines in a way that patients can understand so that they know the measures being taken to ensure their privacy is protected, but also delineate how their PHI is being used in a way that progresses science. This can look like walking patients through the de-identification process so that they understand that the digital biomarker data connected to their face, for example, is randomized into unrecognizable images of their eyes, nose and mouth. With clear governance around deidentification, encryption and security technology, patients can also have more confidence in submitting their data for short and long-term use to help advance future research.
Setting a Global Privacy Standard
Patients need to be able to trust in the medical and technological institutions that are designed to aid them, which can be brought about by more consistency in regulations governing privacy. Governments, technology and healthcare organizations across the world must come together to rally for a much-needed streamlining of privacy regulation, so that patients can feel better about sharing their critically important data in clinical trials, and researchers can in turn create medicines that better suit patients’ unique needs. Future regulations should also allow for the diverse use of research data without the risk of trial delays or having sponsors’ protocols rejected based on the use of data outside the parameters of a particular trial. Once the proper guidelines have been set, data will be more easily shared across institutions and borders, and de-identified PHI from past studies will be able to be built off of for future research, leading to unprecedented advancements to the science of medicine.
