Quality and Safety of Health Mobile Applications: Are They an Issue?

Abstract

mHealth is a huge market that provides users the opportunity to have better health and healthcare quality. Health apps support citizen’s empowerment through self-management, health promotion, disease prevention, providing personalized health advice and care. However, the rapid development of the mHealth sector raises concerns about the potential risk of health functions apps providing transmission of health data, the capture of these data via sensors, self-diagnoses, disease management or diagnosis and appropriate processing of the data collected. Since mHealth solutions and devices can collect large quantities of personal information, including personal health information, they can process them as well.

The mHONcode is a set of ethical, honesty, transparency, quality, and security standards covering various aspects of health apps, including the disclosure of the qualifications of the authors, the funding sources, references, when the content was created and last updated, what the privacy policy is, and how data is stored and transmitted over the internet. The mHONcode motivates health apps editors to be transparent in the production process and in the way to use user’s data. The commitment of a health information provider to implement or comply with the HON code of conduct for health apps is shown by the displaying of a quality label (logo or HONcode seal) on the website.

As the adaptation of an already proven trustworthy code of conduct of health websites (the HONcode), the mHONcode is well placed to provide guidance for the next generation of health information providers—mobile apps in this case.

Appendices

Appendix: Answers to Review Questions

• 1. What kind of special risks arise from apps on mobile devices compared to websites?

  Websites display the data as they are part of the content of this site which is therefore easy to check also in terms of how they are produced. In apps, the algorithms used to analyze the data are kept secret and are not disclosed because they belong to the business model of the app. The privacy and security of transmission and storage is very difficult to test and assess in apps as well. Apps play the role of a “medical device” even if by definition of the relevant laws they are not which is unlike health websites. They do not play a diagnostic role but only an informational role.

• 2. Why is it a problem to assess many features of the app as different frameworks suggest?

  Too many criteria to be assessed may lead to a situation in which developers are reluctant to have their app assessed due to potentially high costs and inefficient practices. This in turn entails a low number of apps being actually assessed. In contrast, transparency and honesty in the production of the apps will engage developers to disclose what is behind the scene and be responsible to what health app it develops. Furthermore, not all apps need the same attention as they do not imply the same potential risk to consumers. For example, health apps with calculators and algorithms intended to recommend an action or medications may directly impact the user’s health and must be scrutinized thoroughly, while diary apps just used for documentation are less critical.

• 3. What are the eight principles of the mHONcode?

  • 1. Authority.

  • 2. Complementarity.

  • 3. Confidentiality.

  • 4. Validity.

  • 5. Justifiability & Objectivity.

  • 6. User’s practice.

  • 7. Financial disclosure.

  • 8. Advertisement policy

• 4. Please describe the mHONcode certification process!

  Step 1: The health app owner voluntarily applies via the HON website for the mHONcode certification for manual evaluation by an expert medical team and a security officer according to the mHON principles and associated published guidelines.

  Step 2: The health app editor needs to fill in a self-reporting mHONcode questionnaire with 34 questions related to the mHONcode guidelines.

  Step 3: The HON’s reviewer analyzes the content of the health app and assesses if it conforms or not to the given principle.

  Step 4: For any principles that have not been respected, the HONcode reviewer delivers a detailed report at the end of the process with recommendations on how to improve the health app. This resulting evaluation report helps the health app editor to render content that is HONcode compliant and transparent.

Appendix: Definitions of Terms in the Text

Digital engagement: Anything that involves a conversation online.

Digital care: An evidence-based software intervention (a program, application, or the like) that is intended to prevent or treat a disease and carries the attributes below.

Data security: Protective digital privacy measures that are applied to prevent unauthorized access to computers, databases, and websites.

e-Health: e-Health is a broad term, and refers to the use of information and communications technologies in healthcare.

Digital health technology: Digital health, which includes digital care programs, is the convergence of digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery and make medicine more personalized and precise.

Population health: The health outcomes of a group of individuals, including the distribution of such outcomes within the group.

Encryption: The process of converting information or data into a code, especially to prevent unauthorized access.

Algorithms: A process or set of rules to be followed in calculations or other problem-solving operations, especially by a computer.

Cryptography: A method of protecting information and communications through the use of codes, so that only those for whom the information is intended can read and process it.

Data minimization: The principle of data minimization involves limiting data collection to only what is required to fulfill a specific purpose.