The Health Information Technology for Economic and Clinical Health Act included in the American Recovery and Reinvestment Act of 20091 brought about major investment and incentives to use and develop innovative and impactful health information technologies. As an outcome of this investment, in less than a decade, clinical data are now largely recorded, managed, and sometimes shared digitally in the US. This digital health revolution has transformed how clinicians document clinical encounters and how consumers access their health information, record and track their health data, manage their diseases, and promote their own wellness. While these transformations have brought tremendous opportunities and potential for both individual- and population-level benefits, they have also brought some very big challenges and potential for harm.

One major innovation directly impacting consumer is mHealth, often referred to as mHealth, and is in the form of health "apps." These health "apps" are the design and use of mobile, wearable, and wireless technologies for the purpose of improving an individual's health.2 Given the high penetration of mobile phone ownership3 and enthusiastic adoption of many wellness, fitness, and disease-focused mHealth, these apps have potential to make a major impact on chronic diseases and health promotion. However, these apps often have mixed evidence of effectiveness,4,5 lack integration with clinician generated health data,6 and a particularly concerning lack of involvement of qualified clinicians in the mHealth development.7 In addition, there is confusion, both among consumers and clinicians, about which mHealth apps are grounded in robust clinical evidence, and only a small fraction receive oversight from the Food and Drug Administration.8,9 Finally, with some mHealth creeping in the direction of diagnosis and treatment,8 patient harm is a concern. There is potential for both misdiagnosis and infective treatment, as well as important threats to both privacy and security.6 As a result, clinicians lack evidence to recommend mHealth apps, and consumers lack guidance on app selection.

XCERTIA

One nonprofit organization seeking to address this uncertainty and regulatory gap is Xcertia (https://www.xcertia.org/). Xcertia is a multidisciplinary group of stakeholders, including the Alliance for Nursing Informatics (ANI), pioneered by leading health information technology and medical organizations that have developed a voluntary set of guidelines for safe and effective use of mHealth. The guidelines focus on five key areas: (1) operability, (2) privacy, (3) security, (4) app content, and (5) usability. To incorporate a wide array of expert opinions, Xcertia used a stepwise consensus process that involved more than 100 experts as follows: (1) guideline draft development by workgroups in each area, (2) review revision and endorsement by the Board of Directors, (4) an online public commenting period, (5) workgroup review and incorporation of relevant comments, and (6) final guidelines release.

As Xcertia's guidelines development and dissemination period nears completion, the next step in the organizations journey is to encourage and foster guideline adoption. In the absence of strong federal interest in overseeing this process, another option is to promote voluntary certification. Although voluntary certification may take time for adoption, there is evidence that similar certification and accreditation programs in healthcare are now widely used and lead to improved care processes and patient outcomes.10 The incentive of certification for mHealth developers is that meeting a well thought-out, rigorous, and recognized certification process will lead to increased recommendation by clinicians, adoption, and use of their mHealth9 by consumers that would thereby drive the developers' profits.

The CARIN Alliance

As introduced to the ANI community in early 2018, ANI continues to represent nursing informatics on the board of the CARIN Alliance (https://www.carinalliance.com/).11 The CARIN Alliance advocates for consumer directed exchange. Specifically, CARIN promotes the ability for consumers and their caregivers to easily obtain their health data using application programming interfaces or APIs. Using a healthcare application of their choice, consumers and their caregivers should be able to access, use, and share data based on an individual's right of access to retrieve his/her own electronic health care information.

Over the past year, ANI has contributed to a number of CARIN Alliance strategic initiatives. In December 2018, CARIN Alliance released a Voluntary Code of Conduct on the exchange of health care data outside of HIPAA.12 This is based on the idea that third-party applications need to ensure consumers, or their authorized caregivers, provide informed and proactive consent for how their health care data are collected, used, and shared. The intent of this first phase is that vendors will self-attest or pledge to follow the code of conduct. Phase 2, due out in 2019, will be a set of questions regarding how mHealth apps will use the health data, and phase 3 will work with third-party certifiers to validate the vendor's self-attestations.

As part of the CARIN policy workgroup, a document on the benefits of APIs was developed, and the workgroup responded to a number of proposed rules in early 2019, including topics such as trusted exchange framework, information blocking, patient access and interoperability, and the HIPAA Request for Information (https://www.carinalliance.com/our-work/policy-regulatory/). The newly formed Post-Acute Care workgroup is in the process of drafting a proposed work plan and will convene in 2019.

Poor-quality mHealth and the right of consumers to easily obtain their health data represent important challenges in this digital healthcare era. In nurses' essential roles as patient advocates, nurses must address these challenges. Nurse informaticists in particular are uniquely suited to bridge patient advocacy with their expertise in health data and health information technologies. In addition, as a profession, nursing needs to ensure that expert nurses are appointed to boards in order to be in a position to shape health policy that will lead to meaningful changes at a national level.13,14 Fortunately, ANI endeavors to find opportunities for nurses in this area and contributes as needed to organizations by appointing qualified members to serve on boards. These appointed board members also serve as liaisons between the nursing informatics community and these organizations by providing regular updates at the quarterly ANI meetings, engaging other nursing informatics members to participate as needed. Interested readers are invited to contact the authors.

References