A Guide to Regulatory Compliance While Developing a Healthcare Application

What makes or breaks a healthcare application is the level of security or privacy measures integrated in a software. 

To implement privacy and security measures, one essential ingredient required while developing a healthcare application is regulatory compliance. 

Regulatory compliances cost a fortune for the healthcare industry. The expenditure on administration to support compliance measures for an average community hospital with 161 beds is around $7.6 million yearly.

Despite high expenses, adhering to compliance is important to avoid penalties by the government. However, why is regulatory compliance needed and which ones are mandatory while developing a healthcare application? 

Why Do You Need Regulatory Compliance?

Healthcare regulatory compliance involves adhering to rules and regulations that are in favor of the healthcare sector and doesn’t result in any federal fines or penalties. 

Regulatory compliance covers areas but are not limited to billing, patient care, reimbursement, HIPAA (Health Insurance Portability and Accountability Act) security and privacy, OSHA, and managed care. Healthcare compliance helps medical organizations to avoid problems with the government authorities. 

An effective compliance helps a healthcare facility or medical practitioner to avert liability for any malpractices. A regulatory compliance is a continuous process that revolves around policies, updated procedures, and constant reviewing. 

Regulatory compliance helps to tackle issues in the healthcare sector such as – 

  1. Value based compensation
  2. Data breaches and HIPAA
  3. Anti-kickback problems
  4. Qualification for telehealth provider
  5. Due diligence procedures
  6. Tax-exempt issues
  7. Recovery audit contractors

Compliance ensures smooth, safe, and high quality of care to the patients. This helps physicians to follow a protocol while diagnosing patients and to maintain strict privacy of medical data. 

Healthcare Compliance and Regulations in the USA


The Health Insurance Portability and Accountability Act (HIPAA) was issued by the US Department of Health and Human Services (HHS). 

This act addresses the disclosure and use of PHI (Protected Health Information) by covered entities who are subjected to privacy rules. These include healthcare providers, business associates, health plans, and healthcare clearinghouses. 

HIPAA contains standards for people’s rights on how to control their health data and where to use it. Major role of HIPAA compliance is to assure that PHI is protected and medical data is safely exchanged between medical staff for quality care. 

This act maintains balance between use of medical data and at the same time protects it to maintain privacy. Violations of HIPAA compliance results in penalties which can range from $100 to $1.5 million based on per incident violations. 

Further, HIPAA security rule protects health data when a covered entity receives, creates, transmits, or maintains this data in electronic format. The security rule doesn’t apply for PHI that’s transmitted in written or oral format.   


The Health Information Technology for Economic and Clinical Health Act (HITECH) was introduced during the administration of President Barack Obama. 

The goal to create this act was to expand and promote the adoption of the health information technology – EHR by the healthcare professionals and facilities. HITECH eliminated several loopholes from the HIPAA act, and this helped to send the business associates who were complying with HIPAA, to affected individuals when PHI was compromised. 

Through HITECH compliance, hospitals and healthcare professionals can leverage incentives to transition from paperwork to electronic documentation. Further, HITECH assures that all covered entities adhere to the HIPAA compliance.   

3. HL7 Standards

Health Level Standards or HL7 is a non-profit organization that creates industry benchmarks for integration, exchange, retrieval, and sharing of electronic health information. By incorporating HL7 standards, developers can make writing software more intuitive. HL7 helps to make clinical research effective and provides a safe caring environment for patients. 

HL7 offers tools needed to make essential operational information such as staff scheduling and patient data. This helps to automate workflows and exchange PHI efficiently. 

These standards are a guide on how to compile clinical information and it doesn’t address the question on how to build a healthcare application or software. HL7 standards are recognized globally and commonly used in the medical field. 

Each version of these standards is more stringent for improving consistency for healthcare organizations. 


Bring Your Own Device (BYOD) refers to employers carrying their devices for connecting with organizational networks. This also includes accessing work systems and sensitive information. Devices can include personal computers, smartphones, USB, or tablets. 

BYOD security or compliance in healthcare facilities is essential because it presents severe security challenges as these devices go unsanctioned.

BYOD security policies guide and educate healthcare professionals on how to use BYOD without compromising PHI. This tool is helpful in boosting productivity of medical staff and supports flexible workflows. 

Further, upgraded technologies are easily integrated without much expense on hardware, device maintenance, or software licensing. Speed and comfort of own devices builds high effectivity. 

Policies on BYOD are becoming prevalent within healthcare sectors to address pressing issues related to security and privacy. 

With the rise in spending in the healthcare sector due to technologies such as telemedicine, mHealth, wearables, or sensors, the need for regulatory compliance will continue to march uphill. Rigid compliance policies and integration of features will be the key to develop robust healthcare applications.     

Make your program more care-centric today.

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