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How Mobile App Development Companies Address Healthcare Regulations

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 

  1. 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.  

  1. 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).  

  1. 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.  

  1. 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).  

  1. 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. 

  1. 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.

IEMLabs is an ISO 27001:2013 and ISO 9001:2015 certified company, we are also a proud member of EC Council, NASSCOM, Data Security Council of India (DSCI), Indian Chamber of Commerce (ICC), U.S. Chamber of Commerce, and Confederation of Indian Industry (CII). The company was established in 2016 with a vision in mind to provide Cyber Security to the digital world and make them Hack Proof. The question is why are we suddenly talking about Cyber Security and all this stuff? With the development of technology, more and more companies are shifting their business to Digital World which is resulting in the increase in Cyber Crimes.


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