Health apps and digital care
Health apps range from fitness and nutrition trackers to software connected with medical devices, and digital care extends to remote monitoring, digital drugs and tools that connect patients with professional and informal caregivers. Concern about who writes apps and what they claim has brought proposals for disclosing an app's authorship, sources and funding, for rating its quality and for protecting the privacy of the data it holds, and a case for involving medical writers in building them.
The health app market
Mobile health apps let consumers, patients and health care practitioners manage health in their own hands and have the potential to guide people to improved health-based decisions. Some apps track weight, caloric intake and exercise or give information on the effects of medications on breast milk, and others help professionals treat radiation injuries or diagnose cancer or heart rhythm abnormalities. Thousands of health apps were available by 2018, using different approaches for different audiences and ranging from fitness and nutrition trackers to apps connected with existing medical devices, such as blood monitors and complex medication infusion systems. Important differences between them include their primary use cases, their medical content or nature, and the software development infrastructure behind them.
A German market research firm estimated in 2014 that the mobile health app market, which reached $2.4 billion in revenue in 2013, would reach $26 billion by the end of 2017. The number of apps had more than doubled over the preceding several years, and more than 100,000 health apps were available for iOS and Android in 2014. Nearly 250 million people downloaded a health app in 2012, a number projected to double to 500 million by 2015, and by 2018 nearly half of the world's 3.4 billion smartphone and tablet users were expected to download a mobile health app of some kind. Although the public is seen as the main audience for many of the apps, 43% were designed primarily for health care professionals.
A business analysis report released in 2016 put remote monitoring (32%), diagnostic apps (31%) and medical condition management (30%) as the three mobile health app categories with the greatest market potential.
Apps for people with diabetes
People living with diabetes make about 50 disease-related decisions every day and often struggle to balance their blood glucose, a tedious and challenging process. New mobile applications are designed to support them, and the most effective provide a consumer-friendly user experience and increasingly meet patients' expectations of reducing the disease burden. In the view of a speaker from the International Diabetes Federation, diabetes apps that affect disease management should be considered medical devices and regulated accordingly. Six groups of health apps are relevant to people with diabetes:
- Logbook trackers, documenting daily events such as blood sugar levels, exercise and medication.
- Nutrition and exercise apps, encouraging people to be active and to take care of nutrition, and facilitating carbohydrate counting.
- Motivation, education and coaching programmes.
- Middleware and e-healthcare solutions, serving as a medium to communicate with medical devices and health systems.
- Device manufacturer software, for devices such as insulin pumps, continuous glucose monitors and traditional blood glucose meters.
- Do-it-yourself apps created by patients, such as those of the NightScout Foundation for remote glucose monitoring.
The same speaker held that medical writers involved in developing diabetic medical devices can influence people with diabetes through the written word, which can also reach them through medical apps. Their message should present accurate information about the condition, dispel outdated stereotypes and be adjusted to the phase of the disease. It should be inspiring and motivational and not always so focused on complications, while making a balanced argument that keeps the text realistic, and any description of the use of a medical device should be supported by real-life examples. Good communication and an understanding of patient expectations can help create medical devices people will love.
Remote monitoring, prevention and digital therapies
In 2007 "body computing" was a newly coined term for the use of implanted wireless cardiac devices to transmit up-to-the-second physiologic data. Its applications were then prospective: alerting family members, for example by mobile phone, to a change in a person's health requiring emergency assistance; giving emergency physicians vital signs before a patient arrives; and, outside patient care, athletes who might someday swallow smart pills reporting information of value to their trainers, and healthy people using cardiac monitors for feedback on the effects of their lifestyle choices.
People who know their risk factors and predispositions for certain diseases can be motivated to improve their own outlook. By 2012 the health 2.0 environment was making programmes tailored to specific diseases easier to reach. An online start-up focusing on disease prevention, for example, had built its first web-based programme for people with prediabetes, dividing them into small groups each matched with a coach who guides them through a 16-week lifestyle course. Its aim was to combine the advantages of technology with social support to enhance adherence and so improve participants' long-term health outlook.
A mobile app for screening, brief intervention and referral to treatment, a highly promoted approach to identifying and treating people at risk of alcohol or drug problems, was developed to carry medical knowledge and skills from the classroom into clinical practice. It addresses alcohol and drug use and commonly co-occurring depression and anxiety. In remote monitoring, cloud-connected web portals and mobile systems help review, report and analyse real-time patient data, observe drug-related problems during home visits and communicate them to general practitioners and pharmacists. The US Food and Drug Administration approved reSET, described as the first digital drug, in 2018 for treating patients with substance use disorders. Digital technologies were being used to deliver music-based interventions in combination with drugs in pain, epilepsy, stroke, dementia and other chronic conditions. In stroke, for example, a music-based video game, MusicGlove, received clearance from the US Food and Drug Administration after a pivotal clinical study.
Uptake and acceptance of digital care
Social and health systems differ widely in connectivity, internet service use and the integration of digital technology. In the EU the uptake of digital products and services varies in sophistication, and although data-related technology users are growing rapidly in number, data use in healthcare still lags behind. Healthcare is an information-driven sector in which the choice of adequate communication channels and of target-oriented content is highly important, yet in Germany there are barriers to developing suitable and sustainable digital communications comprehensively.
Digitalised healthcare connects professional and informal caregivers through digital communication tools and platforms, which communicate health information and are also intended to improve social interaction through online assistance. But in long-term care, personal relationships between patients and physicians, nurses or caregivers matter greatly, and the perceived quality of the service is strongly linked to them. Every stakeholder views a move from personal interaction to digitalised tools critically, so implementation problems slow digitalised health down. Acceptance of digitalisation in caregiving, by patients and by healthcare professionals, depends on understanding the scope and application area of digital supportive systems.
Accepting robots in caregiving depends on users understanding their scope of activity and which services they will replace. Detailed information about the tasks robots are expected to accompany or take over in long-term care is crucial to promoting digital use, so practical and understandable information is needed about the role robots will play in specific caregiving scenarios. It is also important to understand caregivers' beliefs about the impact robots will make, whether as a complement or a substitute.
A specific healthcare communications approach may help end-users understand new digital technologies such as robots or new digital frameworks and bridge from analogue healthcare relations. Such guides may help professionals communicate nursing care concepts and inform patients how far digitalised tools and services can help in long-term care, and nurses and informal caregivers could both benefit from them. Good practice standards in medical writing may help convey digital health contexts to a wide range of target groups. The challenge will be to address health and digital literacy properly for those different groups.
Who writes health apps and what they claim
Traditional gatekeepers of health information wrote few mobile health apps. By the German market research firm's count, gatekeepers such as hospitals and insurers authored just 3.4% of mobile health apps, and downloads of their apps were often far below average. In 2013 an orthopaedic surgeon noted that developers often wrote app software without any formal medical training and that review by physicians or medical associations was purely voluntary. Many apps included a legal statement but were not required to disclose their limitations or information sources, so in his view a legitimate concern about the development of harmful apps existed. A 2012 study of 68 apps on colorectal disease found named medical professional involvement in only 32%.
Concern about apps written and published by nonexperts extends from where their information comes from to the safety and soundness of some of the treatments they suggest. In 2012 an investigative journalist wrote that many apps did not follow established medical guidelines and that few had been tested through clinical research. An examination of 1,500 paid health apps that she led that year found more than one in five claiming to treat or even cure medical problems, some offering lights or vibrations from the phone to aid treatment. Deceptive practices can bring app makers into trouble with the Federal Trade Commission: in 2015, after action by the Commission, marketers of two apps agreed to settlements barring them from claiming without support that their apps could detect early symptoms of melanoma.
Apps for health care professionals
The journalist who examined the paid health apps also held that many outstanding health apps, particularly those intended for doctors and hospitals, were helping to revolutionise medical care. In a report of May 2014, 70% of medical school health care professionals and students used at least one medical app regularly and 50% used their favourite app daily. Apps help practitioners review and update health records, manage information, communicate, gather references and do research, and, according to the 2014 report, they can help in clinical decision-making and education. The US Food and Drug Administration has asserted that practitioners may use apps to help diagnose major diseases. The report held that apps benefit professionals through increased access to point-of-care tools, which has been shown to support better clinical decision-making and improved patient outcomes. It put professionals' hesitation down to mistrust of the apps' standards and validation practices, and held that better standards and validation practices needed to be established to ensure the apps' proper use and integration into medical practice.
Disclosing authorship and rating quality
Some have proposed that publication information about health apps be made full and transparent. Boulos and colleagues, for example, proposed that an app should readily provide authorship information, including the authors' affiliations and credentials and any medical professional involvement in content preparation; list all references or sources of content; fully disclose any sponsorship, other commercial funding and potential conflicts of interest; and ensure balanced, non-biased coverage and up-to-date information. They suggested that reviews could cover an app's purpose, effectiveness and value, and that developers and publishers should routinely consider these factors, perhaps as a checklist added to their quality assurance procedures, as a kind of industry self-regulation or voluntary certification.
The National Health Service in England ran a Health Apps Library recommending apps it had reviewed itself, and the pilot was shut down in late 2015 after concerns that its screening had admitted apps with lenient security standards and questionable effectiveness. One physician commentator held that a fundamental problem with the approach was that it applied a one-size-fits-all solution to finding good health apps. The same commentator noted that many players may join in evaluating apps, among them public and private health systems, sites offering consumer reviews and app review websites. In his view, many apps will warrant centralised scrutiny, but it is impractical to expect all of them to get it, so in many cases end-users, patients and clinicians, will have to assess an app themselves.
In 2015 Stoyanov and colleagues proposed a Mobile App Rating Scale as a reliable, multidimensional measure for trialling, classifying and rating the quality of mobile health apps. They held that it showed promise as a reliable measure, although further research was needed to determine its long-term suitability.
Privacy of app data
Mobile health apps that share patient data with physicians, hospitals or insurance companies should comply with HIPAA. In February 2016 the Department of Health and Human Services published a document for app developers on how HIPAA applies to health information a patient creates, manages or organises through an app and when a developer needs to comply. The document notes that the privacy of consumer information still matters where HIPAA does not apply. The Federal Trade Commission developed an online tool showing developers which federal laws and regulations might apply to their apps.
A role for medical writers
The diversity of health apps and their audiences, and their need for credible health care communication, make the app market of potential importance to a wide range of medical writers and editors, among them those who work on medical device regulatory documents, patient education resources or continuing education materials. The ways apps can fail their users, through lack of oversight, ethics, compliance or transparency or through inaccurate or ineffective communication of medical information, point to a potential role for a qualified medical writer in developing them. App developers often focus on technical usability and do not always make the language a priority. Yet correct, unbiased information presented in a way the intended audience finds hard to understand is useless and makes misunderstanding likely, which can have serious negative health consequences.
One author holds that app developers should therefore consider consulting qualified medical writers to make the information and language in their apps understandable and useful for the intended audience, and with medical writers who have HIPAA training, apps can become compliant on privacy as well. In the same author's view, any strong app should be built in consultation with a qualified medical professional and a medical writer. Publishers can then strengthen their standing by publishing authorship information and perhaps by being vetted through models such as the Mobile App Rating Scale. The same author holds that until regulators give stronger guidance, industry self-regulation and collaboration with qualified health professionals and medical writers are what will enable apps that truly help people and practitioners. Another author held that collaboration and stronger authorial standards will raise the barrier to entering the medical app market and so increase the quality and safety of the apps available to health care practitioners.