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Leaving patients to their own devices? Smart technology, safety and therapeutic relationships Ho, Anita; Quick, Oliver Mar 6, 2018

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DEBATELeaving patients to their oantilntiialithi(DTC) self-monitoring devices and smartphone apps.Smart technology is now central to the vision of variousconcerns.world [3–6].8 to 12% ofdverse event,ical manage-7]. As MerryHo and Quick BMC Medical Ethics  (2018) 19:18 https://doi.org/10.1186/s12910-018-0255-8thing [8]. Medication errors such as prescription of thewrong drug or dosage and missed or delayed diagnoses2Bioethics Program, University of California, San Francisco, San Francisco, USAFull list of author information is available at the end of the articleand Brookbanks explain, an error occurs when someonetries to do the right thing but ends up doing the wrong* Correspondence: anitaho.ethics@gmail.com1Centre for Applied Ethics, University of British Columbia, 227 – 6356Agricultural Road, Vancouver, BC V6T 1Z2, Canadaan ageing population, an increasing prevalence ofchronic conditions, and the goal of keeping patients outof hospitals. However, smart technologies may create adouble-edged sword for therapeutic relationships andPatient safety research is now firmly establfessional and political agendas across theInternational studies estimate that betweenhospital admissions are associated with an ai.e., an unintended injury caused by medment, rather than by the disease process [healthcare systems towards more personalised care de-livery [2], and may be especially useful in the context ofPatient safety and smart technologiesished on pro-Main text: Drawing on lessons learned from other direct-to-consumer health products such as genetic testing, thisarticle explores how smart technology can also pose regulatory challenges and encourage overutilization ofhealthcare services. In order for smart technology to promote safer care and effective therapeutic encounters, thetechnology and its utilization must be safe.Conclusion: This article argues for unified regulatory guidelines and better education for both healthcare providersand patients regarding the benefits and risks of these devices.Keywords: Technology, Telemedicine, Patient safety, Medical ethics, Medical education, Professional regulation,Patient engagementBackgroundThe use of technology in diagnosis and treatment is es-sential to safe and effective health care, although it mayitself cause iatrogenic harm if not properly designed orused [1]. This paper explores the ethical implications ofa specific type of information and communication tech-nology on healthcare delivery: direct-to-consumerpatient safety. On the one hand, when used properly,these technologies may promote safe and effective caredelivery by empowering patients to take charge of theirown health and promote efficient sharing of pertinenthealth information. On the other hand, if not regulatedor incorporated appropriately into clinical care, smarttechnologies can pose significant ethical and safetysafety.Smart technology, safetyrelationshipsAnita Ho1,2,3* and Oliver Quick4AbstractBackground: This debate article explores how smart techsafety and effective therapeutic relationships. Increasing ulikely become an important aspect of self-care and prevesymptom reports, diagnoses, and prompt referral to specmarketing, and use of such technology raise significant e© The Author(s). 2018 Open Access This articInternational License (http://creativecommonsreproduction in any medium, provided you gthe Creative Commons license, and indicate if(http://creativecommons.org/publicdomain/zeOpen Accesswn devices?nd therapeuticologies may create a double-edged sword for patientization of health monitoring devices by patients willve medicine. It may also help to enhance accuratest care where appropriate. However, the development,cal implications for therapeutic relationships and patientle is distributed under the terms of the Creative Commons Attribution 4.0.org/licenses/by/4.0/), which permits unrestricted use, distribution, andive appropriate credit to the original author(s) and the source, provide a link tochanges were made. The Creative Commons Public Domain Dedication waiverro/1.0/) applies to the data made available in this article, unless otherwise stated.Ho and Quick BMC Medical Ethics  (2018) 19:18 Page 2 of 6that result in a delay in referral and treatment are commonproblems [7]. In recent years, the study of adverse eventsand medical errors has evolved into a broader concern withsafety – a more expansive and somewhat nebulous term [9]which presents considerable challenges in terms of meas-urement [10] and regulation [11].Adverse events and medical errors pose specific profes-sional and bioethical implications regarding disclosure topatients as well as general ethical concerns around howmodern healthcare is delivered and coordinated [12]. Ad-vancing health technologies promise more cutting-edgediagnostic and treatment tools. Nonetheless, they alsointroduce new care and process complexities for multidis-ciplinary professionals. Given the basic bioethical tenets ofbeneficence and non-maleficence, finding reliable ways totrack and prevent missed diagnoses is an important fron-tier for patient safety and health service research [13].Connected to this are systematic failures around the com-munication of test results: some countries such as the UKrely on patients to chase up test results and to alert staffof missing and delayed results [14].Various educational and communication strategieshave been identified for improving diagnostic and pre-scription accuracy as well as reporting errors [15]. Infor-mation and e-communication technologies forprofessionals, such as electronic health records andcomputerized physician order entry, are already widelyused [16]. Nonetheless, as monitoring and diagnostictechnologies evolve in the age of person-centred care,can the use of smart technology by patients enhanceboth therapeutic relationships and patient safety? Howcan health systems and regulators ensure the appropriatemarketing and use of such technology so that these de-vices can promote safe and efficient care organisationand delivery?The use of technology by patients managing theirhealth is not new. Patients with chronic conditions suchas hypertension have long been able to purchase bloodpressure monitors, and those with diabetes routinelycarry out blood glucose tests. Other DTC tests can diag-nose sexually transmitted infections [17, 18], detectpregnancy complications such as Group B strep [19],predict bowel cancer [20] and provide preliminary riskassessments for genetic conditions. Diagnostic and treat-ment algorithms, such as devices that can provide ECGreports via phone adaptors, and computer algorithmsthat can analyse photos of skin rashes and send sug-gested diagnosis and treatment options to patients via e-mail or SMS [21], are also increasingly available.As smartphone and its associated technology continueto advance, device companies are increasingly targetingasymptomatic and pre-symptomatic populations, reach-ing not only patients but also healthy consumers. Half ofthe world’s adult population own a smartphone, and thisis predicted to increase to 80% by 2020 [22]. With a lowbarrier to market entry, there are estimated to be over100,000 mobile healthcare apps [23], including variousDTC wellness wearables that continuously track vitalsigns or provide basic dietary and exercise activity infor-mation to users.Smart technology has the potential for promoting eth-ical and effective care delivery in at least two ways. First,beneficence, or the promotion of patient well-being, isgenerally accepted as an important bioethical principle.Traditionally, symptomatic patients have to take severalsteps and rely exclusively on their physicians for directinformation regarding their health. Many pre-symptomatic individuals do not know of their own sus-ceptibility to various conditions and would have to waituntil they have fallen ill before receiving medical atten-tion or advice. Further delay of information ensues if la-boratory tests are ordered. Patients in the UK often haveto take the initiative to obtain their results [14], whereasmany American physicians adopt the “no news is goodnews” approach and wait until they have received con-cerning laboratory reports before making appointmentswith their patients to discuss the findings [24]. Patientsin both systems who do not hear back often wonderwith anxiety whether their results are “normal” orwhether their physicians simply have not received thereports. Worse yet, sometimes reports are missed andpatients who require follow-up investigations or treat-ments are not notified [24, 25].As health-tracking devices allow patients immediateaccess to their health data, they may enhance efficientand timely sharing of vital information to wider patientpopulations as well as facilitate more informed clinicalcounselling. Smart devices may help health professionalsand patients in rural and isolated areas to share and co-ordinate recorded information that is traditionally un-available to such communities, thereby promoting moreequitable access to health information and correspond-ing management options. With smart devices, patientscan ask more relevant and timely questions based on therecorded information, and physicians can confirm theaccuracy of patients’ reports of their symptoms accord-ingly. Patients with busy lives or cognitive decline canparticularly benefit, as they may recall their symptoms,activities, and other information incorrectly [26], espe-cially when there is a significant time lapse between no-ticing the symptoms and consulting a physician [27]. Atother times, patients’ physiological responses (e.g. heartrate) may fluctuate depending on various circumstances(e.g. work stress), such that their physiological markersat the time of their clinical consultation may not tell thefull story. Having recorded information that spans aperiod of time may provide clinicians a more completepicture of the patient’s condition that can help toHo and Quick BMC Medical Ethics  (2018) 19:18 Page 3 of 6facilitate appropriate care and promote better healthoutcomes.Second, the democratization of health informationmay allow consumers to access information for diseaseand illness prevention. More importantly, the directavailability of health information to patients has the po-tential of facilitating a more mutual therapeutic relation-ship, where informed patients can be actively involved intheir care and treatment decisions [28]. By allowing pa-tients and consumers to bypass traditional routes foraccessing certain health information, DTC smart tech-nology can potentially empower consumers in theireveryday lives and patients in the care delivery processrespectively. In the realm of clinical care, the rhetoric ofpatient- and family-centred care abound. Nonetheless,the notions of expertise and legitimacy continue to affectprofessionals’ willingness to take patients’ and families’concerns seriously. As Coulter explains, patient expertiseis often dismissed as a ‘fluffy notion that lacks the solidunderpinning of scientific rigour on which medical careis supposedly built’ [29]. The tendency to under-valueconcerns expressed by patients and their caregivers canbe regarded as a form of testimonial injustice [30], wheretoo much or too little credibility is given to doctors’ orpatients’ words because of prejudices about their re-spective roles. The utilization of smart monitoring tech-nologies, especially if coupled with target counsellingand education by healthcare professionals [31], may in-crease health literacy, empower patients to take a moreactive and informed role in the management of theirown health, and bestow on patients more testimonialcredibility. Connecting to our aforementioned argumentfrom beneficence, if patients can present relevant and re-liable data to validate their symptoms, they may be ableto obtain speedier and more accurate diagnoses, therebyenhancing patient safety and well-being.Patient safety and ethical concerns regarding self-monitoring devicesWhile the increasing use of self-monitoring devices mayfacilitate patient engagement in the care deliveryprocess, their value in promoting better health outcomeswill depend on at least three significant factors.First, the integrity and clinical utility of informationfrom some DTC smart devices are currently question-able. As we learn from criticisms of DTC genetic tests,where individuals can send in cheek swabs to obtaingenetic information regarding their risk of developingvarious conditions such as heart disease, diabetes, can-cer, or Alzheimer’s, these test results may not be clinic-ally meaningful or can be misinterpreted [32]. Medicaldevices are regulated by agencies such as the Food andDrug Administration (FDA) in the USA [33] and theMedicines and Healthcare Products Regulatory Agency(MHRA) in the UK [34]. Products which claim to diag-nose, treat or prevent disease (including software appli-cations) are likely to be classified as devices andregulated accordingly. Nonetheless, despite being aggres-sively marketed as health-promoting tools, wellnesswearables which monitor general fitness are not formallycategorised as medical devices and are thus not regu-lated. Limited studies exist regarding the accuracy orvalidity of various “symptom checker” apps, which aremostly developed by lay entrepreneurs rather thanhealthcare professionals [23]. There is currently noprocess of peer review beyond a simple anonymous userrating scale [35], even though these products may stillpresent psychological and even physical risks to con-sumers and patients if they do not work as intended[36]. Such safety concerns raise questions of how regula-tory and professional bodies should promote non-maleficence and beneficence as per these devices. Sincesome companies appeal to algorithmic authority to pro-mote their apps to potential users [37] or purport to aidpatients to self-diagnose with minimal evidence base, thepotential for misuse is concerning [38]. Care providersmay also have trouble keeping up with these develop-ments, making it challenging for them to educate orwarn patients accordingly. For example, the UK NationalHealth Service (NHS) launched a pilot health apps li-brary in 2013 and currently lists fourty-three apps assafe and trusted for patient use, raising questions aboutthe safety and utility of other DTC devices [39].Second, while meaningful data that can confirm one’shealthy status can reassure most patients, for the “wor-ried well,” the device data may ironically exacerbate theirhealth anxiety and compromise patient safety ratherthan promote productive engagement [40]. In the caseof genetic tests, information about having or not havinga particular gene mutation does not tell the whole storyabout one’s susceptibility to various conditions. Thesame applies to some biomarkers that need to be inter-preted within the context of other variables. For ex-ample, a heart tracing that looks unusual for anasymptomatic person can be meaningless. However, inthe absence of comprehensive patient and consumereducation, healthy but anxious individuals may flock totheir physicians and seek additional testing upon am-biguous results [41]. This can compromise therapeuticrelationships, patient safety, and appropriate allocationof scarce medical resources. From over-prescription ofproton-pump inhibitors to near-universal use ofhormone-replacement therapy for postmenopausalwomen [42, 43], iatrogenic health risks from over-diagnosis and overtreatment abound [44]. The tideagainst medical paternalism may discourage cliniciansfrom overtly dissuading consumers and patients fromusing health-tracking devices. Nonetheless, in the nameof this brief debate article. To maximize the potential ofutilization of a comprehensive risk assessment frame-Ho and Quick BMC Medical Ethics  (2018) 19:18 Page 4 of 6of upholding patient autonomy, physicians may ironicallyfeel pressured to practice “defensive medicine” and orderfurther tests or low-value treatments that may carry otherrisks in order to avoid possible litigation [45]. Transferringthe costs of follow-up testing and care from for-profit de-vice companies to healthcare systems that are alreadyoverstretched also incur wasteful spending and pose just-ice considerations.Third, by marketing directly to consumers, device com-panies are shifting the delicate but important balance inprovider-patient relationships. If device users are primarilyconsumers rather than patients, a “buyer-beware” attitudemay result, diminishing the importance of the therapeuticrelationship. As Entwistle [46] argues, efforts to ‘activate’individual patients to use various devices in the name ofself-care “can be problematic if insufficient account istaken of patients’ own agendas, learning skills, and mater-ial and social circumstances.” An increasing expectation ofpatients to be actively and technologically engaged in theirown care and an over-reliance on these applications re-gardless of patients’ desire, technological literacy, and eco-nomic means may violate patients’ autonomy andexacerbate access disparity [47]. It may marginalize pa-tients who have no affordable or reliable access to internetor mobile technologies, such as people who live in ruralor isolated areas, and affect others who feel uncomfortablewith these technologies (e.g., elderly patients). Moreover,reliance on information from monitoring devices mayironically promote other forms of distrust. On the onehand, smart devices may render patients’ own testimonyas being less credible, if their report cannot be supportedby corresponding “objective” data. These concerns are evi-dent in the treatment of chronic pain, where the pathology(e.g., lower back injury) does not always correspond to thereported severity by the patient [48]. Some physicians maythus question the truthfulness of the patient’s testimonyregarding their symptoms, thereby reducing pain manage-ment ‘problems’ to doubts about patients’ trustworthiness[49]. On the other hand, patients who receive professionaldiagnoses that differ from what the devices suggest – es-pecially for the aforementioned worried well – may dis-trust their physicians and their therapeuticrecommendations. Under-treatment due to distrust of pa-tients’ testimony and dismissal of professional advicebased on patients’ over-reliance on these devices can bothcompromise therapeutic relationships and patient safety.ConclusionSmart technology has the potential to facilitate patientengagement and strengthen the credibility of patient tes-timony, which may in turn help to promote patientsafety and ethical therapeutic relationships. Nonetheless,the reliability and clinical utility of many of these deviceshave yet to be proven. There are also privacy and datawork can help regulatory agencies to evaluate the com-plexity of an application and its probability and severityof harm [50]. Some agencies, such as the aforemen-tioned Food and Drug Administration in the US [33]and the UK Medicines and Healthcare Products Regula-tory Agency [34], are developing guidance on regulatingand monitoring the efficacy of mobile medical applica-tions. Creating a global infrastructure for mobile medicalapplications to provide common guidelines and serve asa repository for shared resources may also help tostandardize safety requirements and promote evidence-based practices for patients [32].Whilst the safety of medical devices is monitored byregulators, much of smart technology (e.g., wellnesswearables) would fall outside of formal regulation, eitherbecause it is not classified as a medical device or becauseof enforcement discretion. Promotion of safe and appro-priate use of these devices requires a more collaborativeapproach among different stakeholders. In particular, itrequires the active educational and supervisory involve-ment of professional organisations and consumer/patientuser experience feedback. In promoting non-maleficenceand beneficence in the realm of smart technologies, pro-fessional organisations and patient advocacy groups canpartner together to ensure that healthcare providers andconsumers/patients are educated about the appropriateuse and limits of these devices. Such collaboration mayoffer a more effective way to gather feedback and pro-mote patient safety than formal regulations. For ex-ample, accredited continuing medical education training,which is widely available for various clinical devices, canbe a model for educating clinicians regarding varioussmart technologies. It is only when these tools are mar-keted and utilised properly in the context of informedand supportive therapeutic relationships that they caneffectively promote not only patient engagement, butalso patient safety.AbbreviationsDTC: Direct-to-consumer; ECG: Electrocardiogram; FDA: Food and DrugAdministration; MHRA: Medicines and Healthcare Products RegulatoryAgency; NHS: National Health Service; SMS: Short message serviceAcknowledgementsWe are grateful for constructive and helpful comments on earlier drafts fromthese technologies, regulatory bodies need to developclear and unified guidelines in distinguishing “recre-ational” from “medical” devices and monitor their mar-keting claims and safety respectively. For example, theconfidentiality considerations that are beyond the scopeDr. John McWilliams, Dr. Stephen Pinney, and our peer reviewers (ElizabethCummings and Phillipa Malpas). We also thank Nigel Hee for literature searchand citation assistance.Ho and Quick BMC Medical Ethics  (2018) 19:18 Page 5 of 6FundingWe thank the National University of Singapore for funding Dr. Ho’s researchon this topic through its internal grant programme. We also thank the BritishHigh Commission and British Council (Singapore) for funding this through itsCollaborative Development Awards Scheme. The funding body played norole in the design of this study or in writing this manuscript.Availability of data and materialsNot applicable.Authors’ contributionsAH and OQ determined the manuscript topic together. They co-wrote differ-ent sections of the initial draft. Both authors then amended and approvedthe final draft.Ethics approval and consent to participateNot applicable.Consent for publicationNot applicable.Competing interestsDr. Ho is a Section Editor for research ethics at BMC Medical Ethics.Nonetheless, this manuscript underwent the usual submission and peer-review process. No other competing interests.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.Author details1Centre for Applied Ethics, University of British Columbia, 227 – 6356Agricultural Road, Vancouver, BC V6T 1Z2, Canada. 2Bioethics Program,University of California, San Francisco, San Francisco, USA. 3Ethics Services,Providence Health Care, Vancouver, Canada. 4University of Bristol Law School,Wills Memorial Building, Bristol BS8 1RJ, UK.Received: 18 May 2017 Accepted: 21 February 2018References1. Newton RC, Mytton OT, Aggarwal R, et al. Making existing technology saferin healthcare. Qual Saf Health Care. 2010;19(Suppl 2):i15–24. https://doi.org/10.1136/qshc.2009.038539.2. National Information Board and Department of Health. Personalised healthand care 2020: using data and technology to transform outcomes forpatients and citizens a framework for action. 2014.3. Federal Ministry of Health. 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Lewis TL, Wyatt JC. mHealth and Mobile Medical Apps: A framework toassess risk and promote safer use. J Med Internet Res 2014 Sep; 16(9): e210Published online. 2014:15. https://doi.org/10.2196/jmir.3133.•  We accept pre-submission inquiries •  Our selector tool helps you to find the most relevant journal•  We provide round the clock customer support •  Convenient online submission•  Thorough peer review•  Inclusion in PubMed and all major indexing services Submit your next manuscript to BioMed Central and we will help you at every step:Ho and Quick BMC Medical Ethics  (2018) 19:18 Page 6 of 6•  Maximum visibility for your researchSubmit your manuscript atwww.biomedcentral.com/submit

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