Understanding Important Regulations and Reforms for Health Apps

Understanding Important Regulations and Reforms for Health Apps

Health apps can help monitor your health, prevent illness, and keep you focused on your wellness goals. When used properly, health apps can be an excellent tool for improved health and wellness for users of all ages.

Because of the significance of health apps in patients’ lives, the government must regulate these tools, and the developers must constantly update them. These ensure that health apps meet strict standards on quality and are safe to use.

Building a health app is about compliance with strict regulations for a healthcare app developer. They must also consider future changes because apps need constant updates to be versatile and abide by the times.

Digital Authority Partners mentioned that the pandemic and other medical concerns have resulted in the demand for health apps for public service. But government agencies are asking developers to be accountable for regulated app development.

Health Apps Regulations

The Food and Drug Administration (FDA) supports the development of mobile medical apps (MMAs), which aim to enhance health care. It also encourages the creation of apps for healthcare professionals to help diagnose and treat their patients. FDA oversees the safety of medical apps and ensures the effectiveness of devices associated with these mobile apps.

Developers must also ensure that healthcare apps follow the Health Insurance Portability and Accountability (HIPAA). This is a governing body that regulates all health and medical apps to maintain protocols for privacy and security. HIPAA is responsible for healthcare apps, while FDA covers medical applications.

What HIPAA Regulates

HIPAA has set up a Privacy Rule that aims:

  • To promote a national standard to ensure the protection of medical records and other personally identifiable information. HIPAA calls these “protected health information.”
  • To protect access to patient health information transacted electronically, such as health plan information, clearinghouse information, and information provided to health care providers.
  • To regulate the use and disclosures of this information. Users must provide authorization to allow the use of their information.
  • To uphold the rights of users over their health information. Users may secure their information or ask for copies of their health records from the health provider or company. Users may request any corrections on their health records.

What FDA Regulates

FDA regulates medical health apps accessed through mobile devices such as smartphones and smartwatches. These apps must meet the governing body’s definition of a medical device or tool. An app may be an accessory to an FDA-regulated medical device.

FDA has released a guidance document that describes how the governing body regulates Class II or moderate-risk device software and Class III or high-risk functions. FDA also described health software functions for non-medical devices and devices that are targets of FDA supervision.

Software developers can email FDA if they want to know more about their software’s level of risk. They can also ask FDA if they need to comply with a pre-market application before releasing their products completely.

FDA does not cover non-medical apps such as the following:

  • Apps used for academic purposes such as electronic journals, periodicals, and books
  • Apps for continuing training and education for healthcare professionals
  • Apps for financial health management
  • Apps that help patients collaborate with their doctors or help doctors collaborate with their peers
  • Apps with illustrations for training and education of patients and healthcare professionals
  • Apps with non-sensitive health information
  • Apps for standardizing medical supplies

FDA does not impose guidelines on these kinds of medical or health apps:

  • Apps that help patients cope with their mental health
  • Apps that help users stop smoking
  • Apps for asthma monitoring
  • Apps for medicine intake
  • Apps for learning different diseases
  • Apps that monitor users’ health statistics such as blood pressure, weight, height, and calorie intake

FDA imposes strict policies to regulate the following apps:

  • Apps that work with sensors to monitor heart rate. These apps are usually integrated with hardware to monitor irregularities in heart rate.
  • Apps that monitor and track changes in the body, such as blood sugar monitoring and oxygen monitoring. Users can share data from these apps with a doctor or specialist for testing and diagnosis.
  • Apps used by people after ear surgery and hearing assistance
  • Apps used for cardiovascular monitoring and treatments
  • Apps that gather data and transfer these to medical hardware or monitor
  • Apps that work with medical tools and devices to help pregnant mothers give birth at home  

Health Apps Reforms

FDA is not responsible for regulating health apps and the use of mobile devices such as smartphones, tablets, and smartwatches. It is the responsibility of app developers to apply health app reforms to ensure that their products are accurate, user-friendly, accessible, and safe to use.

Reforms on Accuracy

Health app developers must ensure that all the information included in their apps is accurate and comes from reputable sources. All facts, figures, and data used to create the app should be from the most updated sources to ensure the app’s usefulness in real time.

Reforms on Usability

Developers must ensure that their health apps are effective, efficient, and safe. These apps must help users achieve their health goals, whether stress relief, weight loss, smoking cessation, back pain relief, etc.

Reforms on Accessibility

Health app developers must consider that their users access their apps using different devices. Today, health apps must not only be available for smartphones but also for smartwatches and tablets. Health apps must also be future-friendly, considering future app uses in different devices.

Reforms on Privacy

Developers must see to it that their health apps conform with HIPAA regulations. They should protect all information gathered from users. Companies that use health apps must seek permission from users to collect and share information from third-party companies.

Final Words

App developers must consider vital regulations and reforms concerning health apps. They must ensure that their apps follow HIPAA to secure users’ health information and conform to FDA guidelines for medical apps. Meanwhile, developers must be keen on implementing health app reforms so that their apps are accurate, usable, accessible, and secure.