ANI CONNECTION Section Editor: Heather Carter-Templeton, PhD, RN-BC Alliance for Informatics Support and Advocacy of Consumer Health

Karen Dunn Lopez, PhD, MPH, RN, Victoria L. Tiase, MSN, RN-BC Alliance for Nursing Informatics, Chicago, IL.

he Health Information Technology for Economic and including the Alliance for Nursing Informatics (ANI), pioneered Clinical Health Act included in the American Recovery by leading health information technology and medical or- T and Reinvestment Act of 20091 brought about major in- ganizations that have developed a voluntary set of guide- vestment and incentives to use and develop innovative and lines for safe and effective use of mHealth. The guidelines impactful health information technologies. As an outcome of focus on five key areas: (1) operability, (2) privacy, (3) secu- this investment, in less than a decade, clinical data are now rity, (4) app content, and (5) usability. To incorporate a wide largely recorded, managed, and sometimes shared digitally array of expert opinions, Xcertia used a stepwise consensus in the US. This digital health revolution has transformed how process that involved more than 100 experts as follows: (1) clinicians document clinical encounters and how consumers guideline draft development by workgroups in each area, access their health information, record and track their health (2) review revision and endorsement by the Board of Direc- data, manage their diseases, and promote their own wellness. tors, (4) an online public commenting period, (5) workgroup While these transformations have brought tremendous oppor- review and incorporation of relevant comments, and (6) final tunities and potential for both individual- and population-level guidelines release. benefits, they have also brought some very big challenges As Xcertia's guidelines development and dissemination and potential for harm. period nears completion, the next step in the organizations One major innovation directly impacting consumer is journey is to encourage and foster guideline adoption. In the mHealth, often referred to as mHealth, and is in the form of absence of strong federal interest in overseeing this process, health “apps.” These health “apps” are the design and use another option is to promote voluntary certification. Although of mobile, wearable, and wireless technologies for the purpose voluntary certification may take time for adoption, there is of improving an individual's health.2 Given the high penetra- evidence that similar certification and accreditation programs tion of mobile phone ownership3 and enthusiastic adoption of inhealthcarearenowwidelyusedandleadtoimprovedcare many wellness, fitness, and disease-focused mHealth, these processes and outcomes.10 The incentive of certifica- apps have potential to make a major impact on chronic dis- tion for mHealth developers is that meeting a well thought- eases and health promotion. However, these apps often have out, rigorous, and recognized certification process will lead mixed evidence of effectiveness,4,5 lack integration with clini- to increased recommendation by clinicians, adoption, and cian generated health data,6 and a particularly concerning use of their mHealth9 by consumers that would thereby drive lack of involvement of qualified clinicians in the mHealth the developers' profits. development.7 In addition, there is confusion, both among consumers and clinicians, about which mHealth apps are The CARIN Alliance grounded in robust clinical evidence, and only a small fraction As introduced to the ANI community in early 2018, ANI receive oversight from the Food and Drug Administration.8,9 continues to represent nursing informatics on the board of Finally, with some mHealth creeping in the direction of diagno- the CARIN Alliance (https://www.carinalliance.com/).11 The sis and treatment,8 patient harm is a concern. There is potential CARIN Alliance advocates for consumer directed exchange. for both misdiagnosis and infective treatment, as well as impor- Specifically, CARIN promotes the ability for consumers tant threats to both privacy and security.6 As a result, clinicians and their caregivers to easily obtain their health data using lack evidence to recommend mHealth apps, and consumers application programming interfaces or APIs. Using a lack guidance on app selection. healthcare application of their choice, consumers and their caregivers should be able to access, use, and share data based XCERTIA on an individual's right of access to retrieve his/her own One nonprofit organization seeking to address this uncer- electronic health care information. tainty and regulatory gap is Xcertia (https://www.xcertia. Over the past year, ANI has contributed to a number of org/). Xcertia is a multidisciplinary group of stakeholders, CARIN Alliance strategic initiatives. In December 2018,

60 CIN: Computers, Informatics, Nursing February 2020

Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved. CARIN Alliance released a Voluntary Code of Conduct on quarterly ANI meetings, engaging other nursing informatics theexchangeofhealthcaredataoutsideofHIPAA.12 This members to participate as needed. Interested readers are in- is based on the idea that third-party applications need to vited to contact the authors. ensure consumers, or their authorized caregivers, provide informed and proactive consent for how their health care References data are collected, used, and shared. The intent of this first 1. American Recovery aND Reinvestment Act of 2009. Law, Explanation and phase is that vendors will self-attest or pledge to follow the Analysis: P. L. 111-5, as Signed by the President on February 17, 2009. code of conduct. Phase 2, due out in 2019, will be a set of Chicago, IL: CCH; 2009. 2. World Health Organization (2011). mHealth: new horizons for health through questions regarding how mHealth apps will use the health mobile technologies: second global survey on eHealth. https://www.who. data, and phase 3 will work with third-party certifiers to val- int/goe/publications/goe_mhealth_web.pdf. Accessed August 1, 2019. idate the vendor's self-attestations. 3. Pew Research Center (2019). Mobile fact sheet. June 12, 2019. https:// As part of the CARIN policy workgroup, a document on www.pewinternet.org/fact-sheet/mobile/. Accessed August 2, 2019. 4. Hamine S, Gerth-Guyette E, Faulx D, Green BB, Ginsburg AS. Impact of the benefits of APIs was developed, and the workgroup re- mHealth chronic disease management on treatment adherence and patient sponded to a number of proposed rules in early 2019, includ- outcomes: a systematic review. Journal of Medical Internet Research. ing topics such as trusted exchange framework, information 2015;17(2): e52. blocking, patient access and interoperability, and the HIPAA 5. Marcolino MS, Oliveira JAQ, D'Agostino M, Ribeiro AL, Alkmim MBM, Novillo- Ortiz D. The impact of mHealth interventions: systematic review of Request for Information (https://www.carinalliance.com/ systematic reviews. JMIR mHealth and uHealth. 2018;6(1): e23. our-work/policy-regulatory/). The newly formed Post-Acute 6. Eng DS, Lee JM. The promise and peril of mobile health applications for Care workgroup is in the process of drafting a proposed work diabetes and endocrinology. Pediatric Diabetes. 2013;14(4): 231–238. plan and will convene in 2019. 7. Ahmed I, Ahmad NS, Ali Set al. Medication adherence apps: review and content analysis. JMIR mHealth and uHealth. 2018;6(3): e62. Poor-quality mHealth and the right of consumers to easily 8. Larson RS. A path to better-quality mHealth apps. JMIR mHealth and uHealth. obtain their health data represent important challenges in this 2018;6(7): e10414. digital healthcare era. In nurses' essential roles as patient advo- 9. Palmer S. Swipe right for health care: how the state may decide the future of cates, nurses must address these challenges. Nurse informaticists the mHealth app industry in the wake of FDA uncertainty. Journal of Legal Medicine. 2017;37(1–2): 249–263. in particular are uniquely suited to bridge 10. Alkhenizan A, Shaw C. Impact of accreditation on the quality of healthcare with their expertise in health data and health information tech- services: a systematic review of the literature. Annals of Saudi Medicine. nologies. In addition, as a profession, nursing needs to ensure 2011;31(4): 407–416. that expert nurses are appointed to boards in order to be in a 11. Tiase VL, Hull SC. Alliance for Nursing Informatics involvement with consumer-directed exchange and the CARIN Alliance. CIN: Computers, position to shape health policy that will lead to meaningful Informatics, Nursing. 2018;36(2): 68–69. 13,14 changes at a national level. Fortunately, ANI endeavors 12. The CARIN Alliance. Trust framework and code of conduct. 2019. https:// to find opportunities for nurses in this area and contributes www.carinalliance.com/our-work/trust-framework-and-code-of-conduct/. as needed to organizations by appointing qualified members Accessed June 11, 2019. 13. Hassmiller S. Taking the first steps to serving on a board. American Nurse to serve on boards. These appointed board members also Today. 2012;7(11): 18–20. serve as liaisons between the nursing informatics community 14. Prybil LD, Dreher MC, Curran CR. Nurses on boards: the time has come. and these organizations by providing regular updates at the Nurse Leader. 2014;12(4): 48–52.

Volume 38 | Number 2 CIN: Computers, Informatics, Nursing 61

Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.