Nature Medicine 논문 정리 (1)
health apps in clinical practice
논문 초록
한글 번역: 기술의 발전, 스마트 폰에 대한 액세스 증가 및 자본 투자로 인해 최근 몇 년 동안 이용 가능한 건강 "앱"의 수가 폭발적으로 증가했습니다. 환자는 스마트 폰을 여러 가지 용도로 사용하지만 건강, 특히 만성 질환 관리를 위해서는 그닥 많이 사용하지 않습니다. 이러한 디지털헬스 앱을 개발, 검증 및 평가를 하기 위해 상당한 노력을 쏟고 있지만 앱을 일상적인 임상 실무에 효과적으로 전파하는 방법은 명확하지 않습니다. 우리는 이 논문에서 앱 처방을위한 프레임 워크를 제안하고 임상 치료에서 앱 보급을 가능하게 하기 위해 해결해야하는 주요 문제를 간략하게 설명합니다. 여기에는 교육 및 인식, 디지털 처방집 작성, 워크 플로우 및 EHR 통합, 지불 모델 및 환자 / 제공자 지원이 포함됩니다. 디지털 헬스케어 분야의 업무는 계속 확대되고 있으며 건강 앱을 임상 치료 제공에 통합하는 것이 디지털 헬스케어의 잠재력을 키우는데 매우 중요할 것입니다.
본문: Fueled by advances in technology, increased access to smartphones, and capital investment, the number of available health “apps” has exploded in recent years. Patients use their smartphones for many things, but not as much as they might for health, especially for managing their chronic conditions. Moreover, while significant work is ongoing to develop, validate, and evaluate these apps, it is less clear how to effectively disseminate apps into routine clinical practice. We propose a framework for prescribing apps and outline the key issues that need to be addressed to enable app dissemination in clinical care. This includes: education and awareness, creating digital formularies, workflow and EHR integration, payment models, and patient/provider support. As work in digital health continues to expand, integrating health apps into clinical care delivery will be critical if digital health is to achieve its potential.
요약본
1. 디지털 헬스케어에 관련된 모바일 앱의 수가 30만개까지 늘어남에 따라 환자들을 위한 헬스케어 시스템의 인터페이스가 많이 바뀌고 있으며 헬스케어를 이용하는 방식이 변하고 있다. The proliferation of health apps in particular—there are now more than 300,000 which have been developed1 is changing how patients interact with the healthcare system.
2. 벤처캐피탈과 사모펀드에서 디지털치료제 분야에 투자한 자본은 2017년 8.4조에서 2018년 10.8조로 성장했다. Capital is pouring in—more than $9 billion was invested by venture capital and private equity towards digital health companies in 2018, $2 billion more than 2017.9
3. FDA recently launched a Digital Health Innovation Action Plan.10 A key component of this plan is a new regulatory pathway for certain software devices called “precertification” that is intended to streamline approval by focusing on application developers and processes as opposed to specific products.11,12
4. Yet even if high-quality apps are developed, the potential of apps to improve the care and wellbeing of patients can be realized only if the tools are actually used.
5. The FDA considers two main subsets of device software functions: Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Software that ultimately meets the definition of a device can be deployed on a mobile platform, at which point it is defined as a “mobile medical app.”3
6.
in the US, regulation of mobile apps follows guidelines set by the Federal Food, Drug, and Cosmetic Act (FD&C Act). Additional examples of federal oversight include the Federal Trade Commission’s Health Breach Notification Rule and the Health Insurance Portability and Accountability Act.19
7. The European Commission eHealth Action Plan 2012–2020, for example, set out a policy roadmap and “digital agenda” for eHealth in Europe.20 Regulation (EU) 2017/745 on Medical Devices (MDR), which began in 2017 and will fully apply in May 2020
8. The EU General Data Protection Regulation (GDPR), which went into effect in May of 2018, also provides important guidance for app developers, particularly around data protection and privacy.
9. Traditional regulatory models have an important role in making certain apps available for clinical care. While some apps have been rigorously studied, there is a general dearth of evidence for health apps, both because a small percentage have been studied, and evidence tends to be low quality for those that have been studied.8,22,23,24
10. App vendors could maintain registries of “certified” providers, which would have the added benefit of alerting interested patients to clinicians that are familiar with a particular app.
11. While pharmacology is a core component of medical education, few clinicians receive formal digital health training27, though there are efforts to improve this through new initiatives like the American Medical Association’s “Accelerating Change in Medical Education Consortium.”28
12. There are several potential ways to implement this required training. First, special licensing could be required for prescribers, similar to a practice waiver for buprenorphine therapies. While this would create a substantial barrier to more widespread app prescriptions, it would create an ecosystem of mandatory certification and training, which might be beneficial if an app is particularly complex.
13. Express Scripts, a large US-based pharmacy benefits manager (PBM), recently announced a digital health formulary.33 CVS Health also recently announced a product that would enable its PBM customers to manage third-party health products.34 Outside the US, the United Kingdom’s National Health Service has launched an “Apps Library,” which is a curated list of health apps, with pricing information, for patients and providers to search for apps which may benefit them.
14. Digital formularies have two main risks. First, while formularies should overall result in lower pricing for patients, there could also be situations where prices go up, for example, through exclusivity deals, or simply because the digital formulary contains an older, more expensive app, and a newer, cheaper one is available. Second, while narrowing the set of available apps will be helpful, digital formularies could also slow diffusion of apps into practice. If providers and patients rely on these formularies as their primary repository, newer, more effective apps will need to overcome the hurdle of getting into a digital formulary to be used.
15. usage will be limited to early champions who dedicate time to learning how to disseminate these apps to their patients, but won’t be accessible to the majority of clinicians who may not prescribe apps because that process exists outside their current workflow.
16. There are several steps that must be accomplished to integrate apps into provider workflow. First, apps should be searchable (for example, from a digital formulary), and then orderable, from the EHR, just like a medication. Second, apps should be integrated with clinical decision support systems to ensure appropriateness. Third, providers should have the ability to note the indication for the app either in the medication history or in a new “digital tools” section of a patient note. Fourth, providers should be able to enter the “sig”—or label for the prescription. Fifth, providers should be able to prescribe parameters for the app, which can be loaded automatically once the patient downloads the app. Sixth, the app prescription should be visible in the EHR like other prescriptions, so that other providers know this app has been prescribed and ideally whether or not it is being used by the patient. Seventh, data generated by the app should be accessible to patients and providers, ideally through existing communication channels like patient portals or other interoperability channels. Finally, there should be mechanisms to de-prescribe an app.
17. Additionally, federally certified EHRs, as a result of national incentive programs and the 21st Century Cures Act, are now required to allow patients to download their data directly through Application Programming Interfaces (APIs), which provides an important, provider-independent mechanism for data exchange.37,38,39
18. Importantly, many apps will be used by patients independent of provider recommendation or prescription (similar to an over-the-counter medication).
19. Technologies to enable some of these features are starting to emerge; some examples include vendors such as Xealth and Rx.Health. We anticipate that EHRs will increasingly enable this as core functionality as well.
20. Payment Mode: Removing copays if patients demonstrate app usage or achieve app-related outcomes. Accountable care organizations might pay for apps for at-risk patients if the app could reduce total medical expense for those patients. Other apps could follow traditional payment models, like using CPT codes that are reimbursed by insurers.40,41,42 Apps could also be packaged with other medical products, like drugs or devices.
21. Finally, as apps become part of clinical workflow, we anticipate an increasing need for user support. The recently formed Digital Medicine Society44 is one step in this direction.
22. The Ochsner health system created the “O Bar”—a physical space that patients can go to obtain recommended digital interventions as well as troubleshoot digital devices. Similar efforts have been implemented at MedStar Health in Maryland, Morristown Medical Center in New Jersey, and Sibley Memorial Hospital in Washington D.C.46
23. FDA is exploring its role in regulating Prescription Drug-Use Related Software (software that is used in conjunction with a medication, which could be used to send administration reminders, track intake, etc.)47
24. Data aggregators, like Apple’s Health Records on iPhone48 enable other apps to utilize EHR data, and could become requirements for specific types of apps to function.
25. Another important consideration is how these apps will impact clinician burnout, which has become an increasing concern amidst evidence of harm to both clinicians and patients.54,55 EHRs are often linked to physician burnout,56,57
26. Conclusion:
As work in digital health continues to expand, we expect more apps to become available, some of which will have evidence of efficacy and regulatory approval. Development and validation are just the first steps. For apps to be used, they must be integrated into clinical practice. We have outlined some of the key areas that will need to be addressed: education and awareness, digital formularies, workflow integration, payment models, and patient/provider support. Integrating apps into routine clinical practice will be essential for digital health to achieve its full potential.
