Healthcare & IT: Medical standards in IT based on HIPAA
Tags: cybersecurity, api, bigdata, healthcare
Published: 2023-07-27 09:25:26

## Post-COVID-19 reality for healthcare
The COVID-19 pandemic has sparked a wave of innovation and technological advancements in healthcare. As we move forward, several exciting trends will reshape how technology is used in healthcare. These include telehealth (remote medical consultations), artificial intelligence and machine learning (using computers to assist doctors and improve diagnoses), data security (protecting patient information), the Internet of Medical Things (connecting medical devices to share data), blockchain (a secure and transparent way to store and share medical records), and virtual reality and augmented reality (using immersive technology for medical training and patient education).

These trends have the potential to greatly improve patient care and outcomes. For example, telehealth allows patients to see a doctor from the comfort of their own homes, saving time and increasing access to healthcare. Artificial intelligence can help doctors make more accurate diagnoses, leading to better treatment plans. Data security measures are crucial to protect patients’ sensitive information from cyber threats. The Internet of Medical Things connects medical devices to share important data, enabling doctors to monitor patients remotely. Blockchain ensures the privacy and integrity of medical records, while virtual reality and augmented reality enhance medical training and help patients better understand their conditions.

It’s important for healthcare organisations to adapt to these trends and prioritise solutions that put patients at the centre. By embracing new technologies, healthcare providers can deliver better care, improve patient outcomes, and meet the changing needs of our post-pandemic world. As technology continues to advance, it will play an increasingly vital role in shaping the future of healthcare.

## IT infrastructure modernization trend in healthcare industry
In 2023, healthcare organisations are adopting new approaches to update their outdated IT systems.
One significant trend is cloud migration, where organisations move their systems to the cloud. This shift helps reduce costs and improves scalability, security, and reliability. The cloud offers a modern infrastructure that can adapt to the changing demands of the digital age, enabling organisations to modernise their legacy systems.

Another approach is the adoption of microservices architecture. This modern software development method breaks down large systems into smaller, independent services. By doing so, healthcare organisations can gradually update their IT infrastructure, improving agility and better responding to evolving needs.

Additionally, the use of low-code and no-code platforms is gaining popularity. These platforms allow non-technical users to build and deploy applications without writing a code. Healthcare organisations can leverage these platforms by quickly creating new applications and integrations, facilitating IT modernization and enhancing the quality of care.

Overall, these trends in 2023 demonstrate the healthcare industry’s commitment to modernise its IT infrastructure, leading to improved efficiency and better patient outcomes.

## Why is it important to follow digital health apps development standards?
When implementing apps and IT systems in the healthcare industry, it is crucial to follow standards. Here’s why:

**1. Easy and safe communication.**

Standards ensure that different systems can talk to each other and share important information. This means that healthcare providers can easily access patient records, test results, and other data when they need it. It helps doctors work together and provide better care for patients.

**2. Accuracy and trustworthiness.**

Standards provide guidelines for how data is collected, stored, and shared. By following these guidelines, healthcare organisations can make sure that the information they have is accurate and reliable. This helps doctors make the right decisions and ensures that patients receive the best care possible.

**3. Protecting privacy and security.**

When it comes to healthcare, keeping patient information safe is incredibly important. Standards help healthcare organisations protect patient privacy and secure their data. By following these standards, organisations can prevent unauthorised access to patient records and keep sensitive information secure.

**4. Meeting legal requirements.**

The healthcare industry is regulated by various laws and regulations. Following standards helps healthcare organisations stay compliant with these rules. This ensures that they avoid legal issues and penalties and maintain a good reputation.

**5. Making systems work together.**

Standards make it easier for different systems and applications to work together. They define common rules and requirements, allowing healthcare organisations to integrate new technologies smoothly. This means that organisations can adapt to changes and take advantage of new innovations in healthcare.

By following standards, healthcare organisations can ensure that different systems can communicate effectively, protect patient privacy and security, and meet legal requirements. It helps create a more efficient and secure healthcare system, leading to better care and improved patient outcomes.

## What is HIPAA compliance in software development?
When developing software for healthcare, it’s important to comply with HIPAA regulations. HIPAA, the Health Insurance Portability and Accountability Act, sets rules to protect sensitive patient information in the United States.

HIPAA compliance in software development means following specific guidelines to ensure the privacy and security of patient’s health data. Here’s what it involves:

**1. Keeping data safe.** Software developers must implement strong security measures to protect patient information from unauthorised access. This includes encrypting data, controlling who can access it, and ensuring secure storage and transmission.

**2. Secure user access.** The software should have strong authentication methods to make sure only authorised individuals can access patient data. User access privileges should be carefully managed to prevent any unauthorised use.

**3. Monitoring and tracking.** The software should maintain detailed logs of user activity and system access. This helps to monitor any unusual or unauthorised actions and ensures accountability.

**4. Assessing and managing risks.** Developers should regularly assess potential vulnerabilities in the software and take steps to minimise risks. This involves conducting security assessments, identifying and fixing vulnerabilities, and keeping the software up to date.

**5. Working with Business Associates.** If the software is used by a business associate of a healthcare organisation, there should be an agreement in place that outlines their responsibilities for protecting patient information.

**6. Training and education.** Developers and others involved in the software development process should receive training on HIPAA regulations and best practices to ensure they understand their role in protecting patient privacy.

By following these guidelines, software developers can help safeguard patient information and ensure that healthcare organisations meet HIPAA requirements. This ensures the privacy and security of patient data, promoting trust and confidence in the healthcare system.

## How to check the application HIPAA compliance? 
Ensuring the compliance of an application with HIPAA requirements involves a series of steps to safeguard patient health information. The following GitHub page has a detailed procedure for creating HIPAA-compliant apps. Here’s a simplified overview of the process:

**1. Understanding HIPAA requirements.** Gain familiarity with the regulations and guidelines associated with software development and data security under HIPAA. This knowledge will help you identify the specific requirements that must be tested for.

**2. Identifying relevant standards. **Determine which HIPAA standards are applicable to your application, such as those concerning security, privacy, breach notification, and data storage. Understanding these standards will guide your testing approach.

**3. Conducting a risk assessment.** Perform a comprehensive assessment to identify potential vulnerabilities and risks to patient data. Evaluate the application’s infrastructure, access controls, data storage, and transmission mechanisms to pinpoint weaknesses and areas in need of improvement.

**4. Developing test cases.** Based on the identified HIPAA requirements and risk assessment findings, create specific test cases that cover each requirement. These test cases should simulate scenarios that validate compliance, such as testing data encryption, user access controls, auditing, and breach notification procedures.

**5. Testing data security.** Evaluate the application’s data security measures, including encryption, authentication, and access controls. Test different user roles and permissions to ensure the proper protection of sensitive patient information.

**6. Testing data transmission.** Verify that data transmission between the application and external systems is secure and aligns with HIPAA requirements. Test the encryption and integrity of data during transmission to prevent unauthorised interception or tampering.

**7. Assessing auditing and logging.** Confirm that the application maintains detailed audit logs and tracks user activities. Ensure that these logs capture relevant information for monitoring and auditing purposes.

**8. Testing incident response and breach notification.** Evaluate the application’s ability to respond to security incidents and breaches. Test the procedures in place for detecting, reporting, and addressing breaches, including timely notification to affected parties as mandated by HIPAA.

**9. Documentation and compliance reporting.** Maintain comprehensive documentation of your testing efforts, including test plans, test cases, and results. This documentation serves as evidence of your compliance endeavours and can be valuable during compliance audits.

**10. Regular monitoring and updates.** HIPAA compliance is an ongoing endeavour. Continuously monitor and update your application’s security measures, policies, and procedures to adapt to evolving threats and changing HIPAA regulations.

It’s crucial to note that testing for HIPAA compliance can be intricate, and it is advisable to involve professionals with expertise in healthcare compliance and data security. Consider consulting with experts or engaging third-party auditors to ensure a thorough and accurate evaluation of your application’s compliance with HIPAA requirements.

## Requirement elicitation process for medical applications
 When developing a healthcare application, ensuring its security is of paramount importance. To elicit requirements on security for such an application, a systematic approach is necessary. Here are steps to guide you through the process:

**1. Identify key stakeholders.** Determine the individuals or groups who have a vested interest in the healthcare application’s security. This may include healthcare professionals, patients, administrators, IT staff, and compliance officers.

**2. Understand regulatory compliance.** Familiarise yourself with the relevant regulations and standards governing healthcare data security, such as HIPAA and GDPR. These regulations provide guidelines for protecting patient information and ensuring privacy.

**3. Engage stakeholders.** Conduct interviews and workshops to gather insights from stakeholders. Understand their concerns, expectations, and requirements regarding security. Encourage discussions on topics like data protection, access controls, encryption, authentication, and secure communication.

**4. Analyse potential threats.** Conduct a thorough analysis of potential security threats specific to healthcare applications. Consider risks such as unauthorised access, data breaches, malware attacks, and insider threats. Identify necessary security measures and controls to mitigate these risks.

**5. Prioritise privacy.** Give due consideration to privacy and confidentiality requirements. Recognize the sensitivity of patient data and assess the need for measures like anonymization, pseudonymization, or encryption to protect patient privacy.

**6. Seek expert guidance.** Collaborate with cybersecurity experts or consultants specialising in healthcare security. Their expertise can provide valuable insights and ensure adherence to industry best practices.

**7. Refer to established standards.** Review established security frameworks and standards specific to healthcare, such as NIST guidelines or HITRUST framework. These resources offer comprehensive security controls and practices that can serve as references.

**8. Document and validate requirements.** Document elicited security requirements in a clear and structured manner. Ensure they are specific, measurable, achievable, relevant, and time-bound (SMART). Validate these requirements with stakeholders to confirm their accuracy and alignment with expectations.

**9. Analyse and prioritise.** Analyse the elicited requirements to identify dependencies, conflicts, and potential trade-offs. Prioritise them based on their criticality, impact on security, and feasibility. Consider the associated cost and effort for each requirement.

**10. Stay updated and evolve.** Acknowledge that security requirements evolve over time. Stay informed about the latest security threats, regulations, and best practices. Continuously communicate and collaborate with stakeholders to update and improve security requirements throughout the development process.

Following these steps will help ensure that your healthcare application is developed with robust security measures, safeguarding patient data, preserving confidentiality, and complying with regulatory standards.

## How to build medical applications which correspond to security standards?
Firstly, thorough research must be conducted to understand regulatory compliance requirements. Different regions and functionalities may fall under specific healthcare regulations and standards. Protected health information typically includes insurance-related data, medical information, personal patient data, appointment dates, medical histories, prescription history, and other sensitive information. Compliance research should be done early on to identify applicable regulations.

For the US market, medical apps storing or transmitting protected personal and medical data must comply with HIPAA. Similarly, the European market requires adherence to GDPR, while Canada follows PIPEDA. Understanding legislative norms is crucial to develop and distribute apps that meet security requirements authorised by governmental legislation.

Encryption plays a vital role in ensuring the confidentiality of eHealth information. By encrypting sensitive data using algorithms and encryption keys, the security of a medical mobile app can be safeguarded. Transport Layer Security (TLS) and Secure Socket Layer (SSL) are cryptographic protocols commonly used for secure communication between a server and an application.

Implementing multi-factor authentication (MFA) adds an extra layer of security. Two-factor authentication (2FA) requires users to present separate pieces of evidence to access data, such as a password and a secondary component like fingerprint or voice identification.

Comprehensive testing, including security testing, is crucial before launching a medical mobile app. Vulnerability testing should cover areas such as weak server-side control, insecure data storage, insufficient transport layer protection, unintended data leakage, poor authorization and authentication, broken cryptography, client-side injection, security decisions via untrusted input, improper session handling, and lack of binary protections.

To protect against attacks, developers must be aware of different types of attackers and their methods. This includes hackers who exploit technical vulnerabilities, social engineers who manipulate human psychology, and man-in-the-middle (MITM) attackers who intercept communications. Preventive measures, secure transmission of data, and up-to-date security protocols like TLS are essential.

Long-term support and maintenance are necessary to address future vulnerabilities and technological advancements in the constantly evolving healthcare industry. Post-release support ensures updates and security maintenance.

Aliaksandra Myslivets, BA Specialist *instinctools