Data Protection: How Technology is Revolutionising Healthcare existing quarantine on the spread of the illness. But quarantines aren’t just about collecting accurate data and analysing it. Putting a community into quarantine is always a last resort by governments and will only be used when it is necessary for the greater good like with an outbreak of Ebola or the Black Death. The reason it is a last resort and its use it highly regulated is that it involves qualitative factors, namely human behaviour, relationships and emotions. Health care professionals may advise family members to inform them about a sick relative, but many families will ignore instructions and try to care for the infected person themselves, until perhaps they too fall victim to the same condition. Data can also be used to identify who the social influencers
may be in a given area, and healthcare professionals can focus on convincing these people about the merits of the quarantine measures being enforced. There’s no guarantee that their influence will convince all families to abandon what they see as their duty, but it may help to persuade some. Real-time data saves lives The important thing to remember about data is that it is useless until it has been analysed and applied to fix a problem. Historical data can be a useful tool for predicting future trends and analysing past behaviour, but anonymised real-time data allows organisations to act immediately by providing people with timely medical care, information and protection from infection. n
Data Protection: How Technology is Revolutionising Healthcare By Dale Jessop, CTO, Exco InTouch
Every week, news stories around the world emerge of data security breaches. Sadly, these are becoming ever more prevalent and sizeable, and no industry is exempt - including healthcare1. Ensuring privacy and security is paramount both in terms of data protection for the patient, as well as enhancing patient confidence in trial participation. But now, some good news: the clinical trials and healthcare arena is undergoing a very noticeable technological revolution. With gathering pace, the pharmaceutical industry is beginning to embrace
technology in a move that is both as encouraging as it is overdue. Digital solutions are now becoming essential both for eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient Reported Outcomes) capture, as well as the healthcare sector, as the industry has realised that it can lead to increased adherence, better health outcomes and, crucially, billions of pounds saved worldwide. The need to protect patient data and provide the most secure environment possible during a clinical trial and real world healthcare situation has, quite rightly, never been more vital. This is, in the main, due to multiple, often complex regulations across different geographic territories, such as compliance with HIPAA, Safe Harbor and EU Data Protection, which are central to safeguarding data privacy in clinical and commercial health services. This comprehensive approach provides confidence for patients that their data will be safe, which, most crucially, reduces a major barrier to enrolment in multi-country programs. The advent of global clinical studies has meant that sponsors need to consider the legislation that vendors are expected to adhere to in order to provide the level of confidence to all stakeholders. Therefore, it is imperative sponsors ensure that the vendors they contract with abide by the respective legislation that governs their
main place of business, for example Safe Harbor, if contracting with a US legal entity and expecting to collect EU patient data, and EU Data Protection if the vendor is based within the EU member states and is collecting EU member states’ patient data. Using technology to ensure data control So, how can technology help meet these guidelines? Firstly, unique PINs are created by users to ensure control over who is entering the data within the ePRO device. Not only is this reducing the risk of fraudulent data entry, but the restricted access also prevents others from seeing the record, and therefore, it enhances data confidentiality. One of the most fundamental methods of data protection is data encryption. With mobile ePRO, both the transmission of data and the offline storage of resting data can be readily secured via this methodology. Furthermore, any ‘sensitive’ data such as Personally Identifiable Information (PII), or indeed the actual content of the completed questionnaire/diary (Protected Health Information (PHI)) are encrypted to ensure data protection. BYOD – dispelling the security myth With the ‘BYOD’ (Bring Your Own Continued on page 22
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