Certifying mobile health apps: Just what the doctor ordered

The healthcare industry is in the midst of a perfect storm, particularly in the area of mHealth. The re-election of President Barack Obama ensures the government's continued support for healthcare technology innovations, as well as initiatives in EHR adoption, accountable care organizations and incentives for quality versus volume. There are currently more than 20,000 mHealth applications in the marketplace, and that number is growing across all mobile platforms.

Hospitals and other healthcare organizations are expanding their use of mobile devices. Employees are using their own devices at work, necessitating companies to evaluate how to integrate them with company technology. Physicians are increasingly using mHealth technology. Insurance companies are starting to promote the use of mHealth apps to increase patient engagement (e.g., health gaming apps). They are also providing reimbursement for solutions that incorporate the use of smartphone apps (e.g., Welldoc's FDA-approved Diabetes Manager and The Center for Connected Health's Healthrageous software system).

Despite this fertile environment, major issues loom. mHealth apps are coarsely categorized into two groups  -  medical and health & wellness. Users have difficulty finding them, and once they do, the app may or may not work. A recent Washington Post article highlighted the lack of scientific basis underlying many mHealth apps. Hospitals are concerned about the privacy and security of patient information. They also have limited app deployment and management capabilities. The physicians using mHealth technology are not necessarily connected to their practice or hospital.

Importantly, the regulatory environment has not kept up with mHealth. Despite remaining largely unregulated, mHealth has recently come under scrutiny. In 2011, the FDA released draft guidance for defining mHealth apps, which may require that certain apps be regulated as medical devices, meaning that these apps would have to fulfill the same clinical, labeling and quality requirements as traditional medical devices. Later that same year, the FTC forced the removal of several apps from the marketplace because it felt they made false and misleading medical claims. It is clear that if mHealth apps are going to succeed in this evolving environment, app developers will have to create useful, credible, reliable programs.

The value of standardization

Healthcare standards have typically developed in response to the desire to promote positive patient practices, improve the quality of medical care and enhance reimbursement. For mHealth apps, certification requires the establishment of standards geared toward the promotion of best practices in functionality, operation, user interface, security, privacy and content. These standards can then be used by the mHealth industry to ensure that issues concerning app quality, safety, security and the like are addressed prior to the app entering the marketplace. This will be critical, as the impact of mHealth apps on clinical decision-making is likely to grow in the future. Physicians and healthcare organizations, who are naturally protective of what their patients engage in or not, may be more inclined to encourage the use of mHealth apps that have been vetted through a certification process. Simply put, certification creates confidence and can alter the way people buy and sell those mHealth applications.

The FTC recently published several recommendations concerning privacy and data security in the mobile space. Included are recommendations that app developers disclose key information clearly and conspicuously, build privacy considerations into the app from the start, be transparent about their privacy practices, offer consumers privacy settings that are easy to find and use and that enable consumers to control how their information is collected, used and disclosed. These should surely be incorporated into any well-thought-out certification process as part of best practices. For those apps that might require FDA approval, meeting certification criteria in those areas may become a prerequisite.

Certification is also a means of demonstrating self-regulation and adherence to applicable codes of conduct. While the general goals of any certification process are to validate and distinguish the efforts of people who have invested time and energy to implement a certain standard or best practice, it is also a major step that a company and/or app developer can use to help mitigate potential liability. 

Happtique's presence in the marketplace

Happtique is a digital and mobile platform for the curation, certification and prescribing of mHealth apps. Happtique's core products and services include:

• A curated application store with more than 15,000 mHealth apps categorized into more than 330 categories, including physician specialties/professions and medical, health and fitness topics;
• White-labeled, secure, custom app formulary health application stores for hospitals and other healthcare enterprises for use by providers, physicians, administrators and patients; 
• AppRx, a patent-pending technology that enables physicians and other healthcare practitioners to electronically prescribe mHealth apps to their patients via a secure, developer-agnostic platform; and  
• A certification program for medical, health and wellness apps

The Happtique App Certification Program (HACP), which will launch early next year, is a voluntary program designed to help consumers, physicians and other healthcare providers identify mHealth applications that meet high operability, privacy and security performance criteria and are based on reliable content. Under the direction of a Blue Ribbon Panel, Happtique has developed a set of standards against which mHealth apps will be evaluated under the HACP. HACP will address standards in four areas: operability, privacy, security and content. Each of these areas has multiple standards and associated performance requirements. 

Under HACP, apps that are submitted for certification will first undergo technical testing by independent testing houses. Those that pass this phase will proceed to review for evaluation of the reliability of content, focusing on the reliability of the source. If an app has been through a clinical or efficacy trial or requires approval by the FDA or other regulatory bodies, this information will be submitted as part of the application for certification. Apps that successfully complete the process will be granted certification status. Specific feedback will be provided about those that were unsuccessful, and they will be able to resubmit once stated issues are corrected. 

Developers interested in learning more about Happtique's App Certification Program can complete the Developer's Inquiry Form on Happtique.com. Anyone interested in being notified when the Happtique App Certification Program launches can sign up here.

Sandra C. Maliszewski, MSN, JD, MBA, is director of the app certification program for Happtique, Inc.