Patient Generated Health Data (PGHD), that is, data captured outside traditional healthcare settings has been attracting a lot of attention lately. Although not a new phenomenon, for in the past, many patients have recorded and shared their health information with their care providers, however, the proliferation of smart phones, remote monitoring devices, downloadable apps and ubiquitous networks are enabling massive growth of PGHD. Few days ago at its annual conference for software developers, Apple announced that it will roll out a new HealthKit platform that is intended to bring a lot of third-party apps into one place so that a blood-pressure reading from one app might trigger an alert and prompt a call from the doctor. A similar instance in the past has shown the likely saving of a patient with chronic heart failure when clinical staff responded immediately to data from an electronic scale in the patient’s home alerting them to her potentially dangerous overnight weight increase. Remote monitoring has shown to be valuable in the treatment of diabetic and heart failure in a number of cases. This is really a way of empowering the patients: a tremendous shift from the paternalistic healthcare model where only the physician is responsible for sickness diagnosis, treatment prescription, as well as compliance assurance that treatment is carried out as prescribed. With the increase in smart devices, including wearable devices that monitor vital signs, there seems to be a conscious and active engagement of patients in this new regime.
This approach to patient empowerment centres on the beliefs that patients are in charge of their own daily care and could be seen as their own de facto healthcare provider, and as such should be viewed as autonomous and equal members of the healthcare team, whose special expertise (knowledge of self) is central to the efficient management of their health. This is important because of the interwoven nature of healthcare with the social, emotional, cultural, psychological, and demographic fabric of a patient’s life, and as such, effective health management would be difficult to achieve if the patient is passively involved in the decision making.
Be that as it may, ICTs are playing a very significant role in this process. For example, the Internet has immensely improved informational access to patients, and encourages their effective participation in healthcare debates by providing a social and networking platform such as patientslikeme.com and 23andme.com, where patients interact with one another as well as share information. The impact of ICTs here could be seen in twofolds: one is by providing a platform that will integrate the vast amount of informational resources openly available, as well as the computational capabilities that are required for analyzing individual patient’s data in order to generate appropriate knowledge that will allow him/her to make an informed decision (clear and personalized documentation). The second is by providing a platform for patients to generate their own health data that might be useful for their healthcare. This means creating data that was hitherto generated in the clinics.
However, the big question in this respect is how to make use of the e-health transformations so that on the one hand, access to EHRs that are mostly used in-house or among healthcare professionals will be given to the patients via their home health apps or devices, and on the other hand, how to seamlessly integrate the vast amount of information that will be generated by the patients into the clinical workflow that will be useful for both them and the healthcare provider (HCP). There appears to be a lot of challenges in actualising this vision of integrating PGHD into the clinical workflow. First is the regulatory concern that these health apps and smart devices are not certified as medical devices. At least under the European Medical Device Directive, any device or software, whether used alone or in combination, which is intended for diagnostic and/or therapeutic purposes, and to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease is a medical device. Similar rules apply in the US. Most app developers may not be aware of this, and in a number of cases are not within the reach of law enforcement, as they make use of cloud facilities to host their apps in other jurisdictions. It is also not certain that these smart phones and other devices have gone through any certification process as medical devices as they were not originally manufactured for health purposes. This means that the assurances and validation requirements for offering of these products in the market as medical devices are lacking in these apps and smart devices.
Apart from the certification concern, there are also issues with EU data protection and security law. In a number of scenarios, the app developers and smart devices manufacturers will fall within the definition of data controllers under EU law, which requires that they have legal bases for the data they are processing, as well as maintain certain data protection principles such as purpose limitation. It is also not clear whether appropriate technical and organizational data security measures have been put in place for the transmission and storage of data from patient to these devices and their backends. This is very critical for HCPs in order to integrate PGHD into their clinical workflow. As this is absolutely reliant on interoperability of the health information system with third party systems, there is the possibility of introducing a weak link in the system where sensitive data is processed. So far, there seems to be no universal standards to seamlessly transition between these environments regarding standardized security and privacy protocols. Regarding medical ethics, it is also doubtful whether users of these devices and apps have obtained the required information and counseling they may need as to the nature of the information they are generating, including the psychological impact it may have on them. This also impacts on the nature of informed consent obtained from the users, which may be questionable under ethical guidelines.
One other issue that HCPs would have to consider before integrating PGHD into their clinical workflow is the reliability and liability for information generated by patient outside their control. What would be the legal liability for clinicians relying or not relying on PGHD? The Project HealthDesign research team has outlined some of these liability-related concerns to include:
• Timeliness and cost, that is, whether HCPs have an obligation to respond to any findings based on such information, and whether they are responsible, if support staff fails to respond or inaccurately interpret data. Relatively, will HCPs be reimbursed for the time spent in reviewing or responding to the finding from PGHD?
• Volume of data and adequacy of responses, that is, whether HCPs could manage the unstructured and voluminous nature of the data captured by these apps and devices, and if so, whether it is possible to respond in a timely manner in view of the work load they already have.
• Accuracy, that is, whether HCPs should trust the accuracy of PGHD irrespective of possible inadvertent actions that could compromise data integrity.
Furthermore, semantic interoperability is yet to be addressed as there is no universal standard for PGHD stakeholders. Patients, app developers, EHR vendors, clinicians, and others do not know precisely what standards would be needed to support PGHD given the nascent and fragmented status of this area. The basic question will be whether the existing technical standards for interoperability among clinical information systems and data exchanges will be adequate and adhered to by the developers and implementers of the PGHD tools or should a new standard be developed.
As events are unfolding in this area, one thing is sure: there is need for more education of all the stakeholders. An American Medical Association policy from 2010 on the use of PGHD by physicians has tried to weigh into the conflict by stating that the physician is responsible only for the use of PGHD that the physician has actively chosen to incorporate into the patient-physician relationship. This is just one step to finding a lasting solution. A lot still needs to be done at harmonising the rules globally. The patients will need to understand the intricacies of these tools, while the app developers and smart device manufactures will have to adhere to the regulations in order to give the required assurances. Additionally, HCPs will need clear guidance on how to modify their systems to incorporate PGHD, and to identify best practices in this regard. There is light at the end of the tunel as the current US Federal Health IT Strategic Plan has the empowerment of individuals with health IT in focus.