Rescuing the Chaotic mHealth App Market: Strategies for Quality, Safety, and Regulation

Mobile health apps are developing rapidly, with a vast application market both domestically and internationally.

To facilitate understanding, we first provide a simple definition of mobile health apps: The so-called mHealth APP refers to medical and health software applications that support mobile devices (such as smartphones, patient monitoring devices, and other wireless devices) in medical and public health practices.

More specifically, mobile health apps are medical applications based on mobile terminals, whose primary function is to provide the public with convenient and timely medical information and diagnostic and treatment services.

In recent years, with the rapid development of China’s mobile internet technology, the mobile health app market has been flourishing. According to the “2015 China ‘Internet+’ Healthcare Research Report” released by iiMedia Research, a globally leading third-party data mining and integrated marketing agency for the mobile internet, the size of China’s mobile health market reached RMB 2.95 billion in 2014. In 2015, the market size is projected to reach RMB 4.27 billion, representing a growth rate of 44.7%. Further insights from relevant research reports by IMS Health indicate that the number of mobile health apps doubled over the past two years. Data from iiMedia Research shows that in the 2015 ranking of development potential for China’s mobile health apps, wearable devices ranked first, pharmaceutical e-commerce second, followed closely by online consultations and appointment registration services.

Several major mainstream mobile health apps have emerged in China, such as Chunyu Yisheng (Spring Rain Doctor), Family Doctor Online, Haodafu Online, DXY (Dingxiang Yisheng), Quick Ask a Doctor, and Xingren Yisheng (Almond Doctor). Moreover, commercial giants including Baidu, Tencent, Alibaba, and Ping An Group have made strong entries into the sector. Based on the data described above, it is not difficult to draw the following conclusion: with the widespread adoption of smartphones and the continuous growth of mobile internet users, the mobile health app market is flourishing.

Current Application Status of Mobile Health Apps: Numerous Issues

Given that mobile health has become a global trend, we have found that nearly all pharmaceutical companies or medical device companies are developing their own mobile applications. It has even become difficult to find a healthcare enterprise without a mobile app. Today, consumers seeking to improve their health through various apps face countless choices. With so many mobile health apps available, can they all provide qualified services to consumers? The answer is no!

Our conclusions are further corroborated by recent findings published in The BMJ (British Medical Journal). The BMJ study raises significant doubts about whether the majority of mobile health apps currently on the market can provide substantial benefits to consumers, with the report even noting that these applications may induce unnecessary anxiety among health-conscious users.

Many mobile health applications lack rigorous clinical validation and are fundamentally unable to demonstrate whether they can substantially improve users’ health outcomes. It is therefore evident that relevant domestic and international authorities need to implement necessary regulatory oversight of mobile health apps to prevent potential market disorder and healthcare risks in the future. Notably, the U.S. Food and Drug Administration (FDA) took the lead by issuing guidance in February 2015 that clearly specifies which mobile medical apps are subject to regulation and which are exempt.

In light of this market reality, we have summarized the numerous issues exposed by mobile health apps both in China and abroad as follows:

1. Data Security and Privacy Protection Issues in Mobile Health Apps
The security of electronic medical records, health profiles, consultation information, and imaging data involved in mobile healthcare apps is a critical issue of widespread concern within the industry. However, the current reality in China is that a unified and comprehensive regulatory framework has yet to be established. Any leakage of such data would deal a devastating blow to the development of the mobile healthcare app industry. Therefore, ensuring data security and privacy in mobile healthcare has become an urgent challenge for mobile healthcare institutions both domestically and internationally.

2. Mobile Health Apps: Convenient but Not Necessarily Reliable
Recently, a review of mobile health apps published in BMC Medicine revealed that the health advice provided by a large number of such apps is unscientific, and in some cases, outright incorrect. The commentary highlighted that insulin dosage recommendations offered by diabetes management apps are problematic, with suggested doses being relatively high; excessive insulin dosing may pose significant risks to patients with diabetes. Professor Kit Huckvale from Imperial College London pointed out that 91% of mobile health apps targeting individuals with diabetes on the market provide flawed insulin dosage recommendations.

3. Market Chaos and Lack of Legal Oversight
Due to the lack of necessary legal management and regulations, mobile health apps not only pose risks such as misdiagnosis, inappropriate treatment, and delayed care, but also suffer from issues including non-standardized operations, unscientific practices, and excessive commercialization. These problems have led to disorder in the mobile health app market, creating a “gray” area characterized by inadequate legal oversight.

4. Mobile Health Apps Lack Formal Credit Ratings
Satish is a cardiologist at Johns Hopkins Hospital and the founder of iMedicalApps, a mobile health platform. His research report indicates that app rankings in major app stores are not strongly correlated with the actual quality of the apps. This discrepancy makes it difficult for consumers to find applications that truly suit their needs. Evidently, professional quality rating agencies need to intervene in the mobile health app market to address rating issues. Mary K. Engle, Associate Director of the Division of Advertising Practices at the U.S. Federal Trade Commission (FTC), explicitly stated in a telephone interview earlier this year that mobile health apps require reliable credibility ratings: “If an application claims to treat, diagnose, or prevent a disease or health condition, it must provide reliable evidence.”

Aspects of Mobile Health Apps That Need Improvement

In 2015, a research paper published in BMC Medicine outlined five effective strategies to enhance the service quality and care standards of mobile health apps. These five strategies are summarized as follows:

1. Enhance the Quality of Mobile Health Apps Themselves
App developers need to further enhance the data literacy capabilities of their software, primarily in two aspects. First, for consumers, it is essential to enable them to use the app efficiently and scientifically, and to objectively interpret the health information and textual data recorded by the app about themselves. Second, for physicians, the patient data and textual records captured by the app should serve as reasonable references and evaluations during disease diagnosis, thereby improving clinicians’ diagnostic accuracy. Of course, both initiatives must be implemented under the premise that patient data security and privacy are fully protected.

2. Establish a Security Alliance for Mobile Health Apps
This Mobile Health App Security Alliance involves app developers, security researchers, government regulatory agencies, and patient representatives. Such a composition of personnel effectively ensures that the developed apps possess reliable trustworthiness and scientific credibility. It can minimize medical accidents caused by unscientific guidance provided by low-quality apps to the greatest extent possible, thereby better safeguarding consumers' personal safety and health experience.

3. A Transparent and Authoritative Third-Party Rating Agency for Mobile Health Apps
As previously mentioned, the app rankings displayed on major app stores do not objectively reflect the actual quality of the applications, thereby creating invisible barriers and difficulties for consumers in making informed choices. In light of this, it is essential to involve authoritative third-party rating agencies. Such agencies should operate independently of app developers, app store operators, healthcare professionals, and patients, conducting more objective and impartial evaluations of the software. This approach will help recommend truly high-quality mobile health apps to consumers, enabling them to better enjoy the convenience and benefits offered by mobile healthcare. Furthermore, third-party rating agencies can serve as arbiters of market competition, promoting the healthy and sustainable development of the mobile health app ecosystem.

4. Proactive and Professional Medical Review
For each mobile health app, it is essential to establish a rigorous review system and mechanism. This system must assume full responsibility for the safety and quality of the app, incorporating everyone from software developers and evaluating specialist clinicians to quality assurance engineers, thereby safeguarding the intrinsic quality of the app. Although this process is challenging, it merits our investment and exploration.

5. Government Regulatory Agencies
For every mobile health app launched on the market, the government must conduct necessary reviews and oversight. It should establish corresponding qualification filings for apps that pass review. The government may consider allocating sufficient resources to existing app regulatory bodies to enhance their enforcement capabilities, thereby ensuring the high quality of medical apps. This regulatory process is as sacred and inviolable as the oversight role played by the U.S. Food and Drug Administration (FDA).

We believe that the five measures outlined above will inject positive vitality into today’s chaotic mobile health app market. One undeniable truth is that the healthy development of the mobile health app market will yield long-term benefits for all stakeholders, from patients and healthcare providers to healthcare systems and insurance payers. Clearly, reform in the mobile health app sector is an inevitable trend. In summary, achieving maturity in the internet-based mobile health industry will require concerted efforts from multiple parties.

Compiled by Chen Kun

Editor: Zhang Nan