The popularity of healthcare app development rises rapidly worldwide. This is a reason an official report has predicted that the healthcare app industry may reach USD 314.6 billion by 2028. Increasing demand of digital healthcare services, rise of telemedicine trend, and growing popularity of wellness apps can make this target achievable. Here, mobile app development services can play a pivotal role in ensuring the performance and experience of these apps.
Though a reputed mobile app development company can build a feature-rich and patient focused healthcare application, it is necessary to overcome regulatory compliance. The healthcare sector is one of the most regulated sectors. When your organization hire dedicated app developers to make an app with desired features, it is of utmost important that your developers meet regulatory requirements properly.
In this post, we will discuss top regulatory compliance and how mobile app development companies address them for making robust healthcare apps.
Top Regulations that Healthcare Apps Must Address
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HIPAA (Health Insurance Portability and Accountability)
As a robust standard for protecting individual’s health information, HIPAA has brought radical changes in the landscape of healthcare sector in the US. It demands strict adherence to established health standards. As per HIPAA, Hospitals and health organizations should have a secure infrastructure with high security to deal with PHI (Protected Health Information) effectively. It ensures patient privacy with secure exchange of healthcare information.
Mobile app development services address HIPAA compliance by adding features like data encryption, access control, audit trails in healthcare apps. App developers use secure APIs for data minimization and ensuring integrity of data. Also, the team of app developers conduct security assessment regularly with vulnerability scans and penetration testing.
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GDPR (General Data Protection Regulation)
Complying this regulation is a must for healthcare applications that serve the EU (European Union). As a comprehensive set of practices, GDPR includes transparent practices for data processing with security measures and users’ control over their data. GDPR requirements are about following ethical data practices and protect privacy rights of individuals.
App development companies can add the necessary safeguards for cross-border data transfers, ensure privacy by design, and facilitate app users to exercise their rights under this regulation. For example, the right to data access, request data erasure, and restrict data processing by establishing DPAs (Data Processing Agreements).
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HITECH (Health Information Technology for Economic and Clinical Health) Act
Passed in 2009, HITECH act is a part of the broader American Recovery and Reinvestment Act. It encourages the adoption and meaningful use of health IT technology in the US. HITECH act promotes the meaningful use of EHRs (Electronic Health Records) while reinforcing the privacy and security provisions of HIPAA. This act has also introduced regulations related to data breach notifications in line with Omnibus update of HIPAA.
App development companies give HIPAA compliance training along with the HITECH Act requirements to their developers. These companies also offer secure data storage for healthcare VR apps along with inbuilt features like audit trails, data encryption, and data minimization. You can hire dedicated app developers for regular assessment and compliance documentation for maintaining the privacy and integrity of PHI when complying with HITECH.
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FTC (Federal Trade Commission)
Though healthcare sector is full of opportunities, it is highly competitive in nature. However, this results in cost reduction and improved patient care with a touch of innovation. Here, FTC plays a vital role in preventing practices that ruin healthy competition within helathcare markets worldwide. It provides healthcare app developers with the necessary support for complying with the US antitrust laws.
App developers should give privacy policies in transparent and clear way stating how the healthcare app collects, shares, uses, and protects the patient’s data. Also, it is essential to obtain explicit consent from app users before gathering any sensitive and personal information. Healthcare app developers need to ensure compliance with COPPA (Compliance with Children’s Online Privacy Protection Act).
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FDA (Food & Drug Administration)
Food and drugs are integral parts of the healthcare sector. The Food and Drug Administration (FDA) involves manufacturing, safety, and marketing of pharmaceuticals and medical devices. As a powerful regulation, it ensures that any software app or a medical device remains secure for usage and resist potential risks by following established rules constantly.
A reliable app development services provider has to adhere to specific guidelines and provisions set by the FDA. Apart from understanding the category of a healthcare app as per the FDA regulation, risk management, design controls, and software validation are essential for making a healthcare app FDA compliant. Healthcare organizations can hire dedicated developers for making changes based on the feedback of post-market surveillance.
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MDR (Medical Device Regulation)
Implementation of MDR is essential within the European Economic Community. It includes monitoring and control of medical devices for safety, quality, and efficiency. It is a modification of the previous regulation Medical Device Directive (MDD) and gives comprehensive guidance on improvements in healthcare applications.
When it comes to complying with existing regulations, app developers find it challenging due to various relative hurdles. Thankfully, MDR has a streamlined and transparent regulatory structure and it can help developers
Apart from these regulations, healthcare apps have to follow local rules and regulations offering the advantage of technological advancements. Let’s understand the future scope of healthcare apps before concluding the post.
Future of Healthcare Applications
Emerging technologies, evolving healthcare needs, and ever-changing patient expectations can make the future of healthcare applications highly promising. Concepts like telemedicine and remote monitoring and technology trends like AI/ML, IoMT, VR, and blockchain will shape the future of healthcare app development.
We can expect that focus will remain on cybersecurity and data privacy with increasing digital footprints in the healthcare sector. Encryption protocols and other features will help healthcare service providers comply with ever-changing regulations. Personalized care solutions, secure insights, and improved patient experiences will drive the future of healthcare applications.
Concluding Lines
Healthcare app development companies have to deal with unique challenges but the right technology and technique can assist them to overcome these challenges. Be it regulatory compliance or act like HITECH, healthcare sector can get the assistance in meeting these legal needs with the help of mobile app development services. If you run a healthcare organization, it is better to consult a reputed and reliable mobile app development company to learn more.
