HIPAA Regulations and Compliance for IT - Development Guide

Find answers to the HIPAA Regulations and Compliance along with relevant understanding, procedures, and other nuances.

The healthcare sector collects various aspects of sensitive patient data to improve services, research innovation, and analyze patterns. To safeguard such information, HIPAA regulations and compliance have become a benchmark to achieve PHI (Patient Health Information) or ePHI security (Protected Patient Health Information), backed by strong public welfare reasons. By the end of 2024, OCR (Office for Civil Rights) got an early intimation of 500 data breach victims. However, when the air cleared, they learned that hackers had gained access to 5,599,699 health information of affected individuals. In fact, there has been a consistent upward trend in the number of data breaches every year.

So, getting an understanding of the importance of HIPAA as a regulation in healthcare, we began asking questions like “What is HIPAA?”, “What are HIPAA Requirements?” and “How it can be implemented.” Stating this, let’s take a deeper dive into the critical aspects of HIPAA compliance.

Introduction to HIPAA

HIPAA, or Health Insurance Portability and Accountability, was passed as an act in 1996. As per HHS (United States Department of Health and Human Services), HIPAA is a federal standard created to protect sensitive patient health information from disclosure without consent. 

Besides this, the HIPAA regulation aims to achieve the following objectives:

• Better Healthcare Quality: A secure exchange of critical patient data for reinforcing the decision to provide necessary care with better coordination and a data-driven approach.
• Enhanced Healthcare Efficiency: Streamlining of administrative processes that include billing and claims processes.
• Combat Fraud and Abuse: Compliant exchange of patient data to ensure prevention and detection of healthcare fraud and abuse.
• Promote Technology Use: Facilitating the adoption of electronic healthcare technologies by securing the infrastructure from any data leakage.

Historical Background and How HIPAA Came To Be

The need for a regulation like HIPAA emerged in the mid-20th century. It happened when companies provided insurance to employees, and the employees felt trapped. To keep the insurance, they had to retain the job, limiting job mobility and leading to a ‘Job Lock’ situation.

HIPAA compliance policy did protect those employees later on, but the regulation was created because of the rise of Electronic Health Records (EHRs). The usage made patient privacy vulnerable as the risk of data breaches increased. Understanding the challenge, in the year 1996, President Bill Clinton signed the HIPAA Act.

Initially, the HIPAA compliance rules were circulated around insurance portability. However, the scope expanded, and later, in 2003, the Privacy Rule became a set national standard to protect health data. HIPAA was further reinforced with strength through the evolution of the 2009 HITECH (Health Information Technology for Economic and Clinical Health Act) Act, ensuring better enforcement and adoption of technological advances, allowing HIPAA-compliant companies today to use ePHIs without any hassle.

What Are HIPAA Requirements?

There are several aspects to HIPAA compliance requirements, including the HITECH Act 2009, Omnibus Rule, Enforcement Rule, etc. However, the core HIPAA compliance rules are:

Privacy Rule 

The Privacy Rule of HIPAA regulations and compliance are created to help individuals protect their medical records and personal healthcare data. It gives the right to the patient to control its usage by covered entities (healthcare providers, healthcare plans, etc.) and how that information is disclosed.

Here are some key aspects of this Rule:

• Patient’s Rights: Right to Access, Right to Amend, Right to Restriction, and Right to Receive a Notice of Privacy Practices.
• Permitted Uses and Disclosures: There are several scenarios in which PHI may be used or disclosed. These are treatment, payment, healthcare operations, public health activities, and law enforcement.
• Minimum Necessary Standard: The patient data used, disclosed, or requested needs to be minimal to achieve the intended task. 

Security Rule 

The HIPAA Security Rule was created to safeguard electronic protected health information (ePHI). As per this rule, covered entities and their business associates are required to implement administrative, physical, and technical safeguards to ensure confidentiality, integrity, and availability of ePHI.

Here, we have mentioned the core features of this rule:

• Administrative Safeguards: This entails safeguarding security management processes and workforce security, as well as providing security awareness and training.
• Physical Safeguards: Here, facility access controls, workstation use, and device + media controls are safeguarded.
• Technical Safeguards: This aspect is about implementing strong access controls on ePHI, audit controls, integrity controls, person or entity authentication, and transmission security.

Breach Notification Rule

This HIPAA data compliance demands covered entities and their business associates to notify all the affected individuals and the secretary of HHS of a certain intensity of breaches of unsecured ePHI.

Notification requirements of this HIPAA compliance guideline are:

• To Affected Individuals: The affected individuals must be notified by covered entities within 60 days of the breach. For this, they are required to reveal information like steps to mitigate potential harm and contact information of responsible parties.
• To the Secretary of HHS: Here, the covered entities need to notify HHS within 60 days of the breach. Also, for breaches that affect 500 or more individuals, covered entities are required to notify prominent media outlets of the state or jurisdiction where the breach happened.
• Exceptions: If the risk assessment notifies low probability of PHI comprise, notification might not be required.

Penalties Associated with HIPAA Compliance Regulations

HIPAA is a mandatory requirement, so even if the covered entities choose to avoid it, there are certain penalties that they have to bear even if no breach incident occurs. 

These penalties are decided based on the nature and extent of violation, and the harm caused by it. In general, the cap of identical violations can range from $25,000 to $1.5 million, as per HHS, in a year. However, there are tiers of penalties as per HITECH Act’s amended section 1176, which are:

1. Tier 1: Did Not Know
   1. Each Violation: $100–$50,000
   2. Maximum Per Year for Identical Violations: $1,500,000
2. Tier 2: Reasonable Cause
   1. Each Violation: $1,000–$50,000
   2. Maximum Per Year for Identical Violations: $1,500,000
3. Tier 3: Willful Neglect - Corrected
   1. Each Violation: $10,000–$50,000
   2. Maximum Per Year for Identical Violations: $1,500,000
4. Tier 4: Willful Neglect - Not Corrected
   1. Each Violation: $50,000
   2. Maximum Per Year for Identical Violations: $1,500,000​

Benefits of HIPAA Compliance

As per the “Enforcement Interim Final Rule” PDF by HHS, there are certain benefits of HIPAA compliance. As inferred from the document, these are some common benefits that can be availed upon becoming compliant with HIPAA:

1. Enhanced Privacy and Security: With HIPAA, the aim is to protect patient electronic health data. The compliance ensures that patient information sustains confidentiality, integrity, and availability of health information.
2. Encourages Compliance Through Penalties: Be it the fear of getting penalized or plain requirement of the covered entities, clear civil money penalties of HIPAA push them towards compliance.
3. Promotion of Accountability: The amendments in HIPAA ensure that covered entities and business associates will be held accountable for violations, thereby improving trust.
4. Support for Electronic Health Records: By adopting HIPAA, healthcare companies are facilitating safe adoptions and meaningful utilization of health information technologies.
5. Improved Enforcement Mechanisms: The tiered approach to penalties employs more targeted enforcement and support entities that understand the obligations of compliance.
6. Public Trust in Health Systems: With a robust, compliant environment and clear guidelines, public trust increases in sharing sensitive information.
7. Flexibility for Covered Entities: With the tiered approach, HIPAA allows for necessary extensions in certain cases. For instance, violations due to reasonable cause and not willful neglect.
8. Support for Innovation in Health IT: Due to data breaches in Healthcare, many healthcare providers were skeptical of using electronic transmission of health data. With clear guidelines that demand necessary precautions, HIPAA is able to support the adoption of innovative health IT solutions.
9. Standardization Across the Industry: Since HIPAA is a mandatory compliance, it has created a uniform standard for data privacy, security, and electronic health transactions nationwide.
10. Enhanced Interoperability: The implementation of HIPAA promotes the usage of standard formats and transactions for electronic health records and information exchanges. This facilitates both data sharing and better communication among providers, insurers, and patients.
11. Focus on Risk Management: The tiered penalty system compels organizations to implement robust risk management practices. This, thereby, helps in identifying vulnerabilities while mitigating potential breaches proactively.
12. Alignment with Broader Healthcare Goals: By implementing HIPAA, improved patient care, reduced fraud, and data-driven improvements can be employed.

Application of HIPAA Compliance- Key Areas to Implement

HIPAA compels related stakeholders to take the necessary steps to ensure robust security measures to protect patient data. While achieving this, there is either direct or indirect application of HIPAA compliance that offers robust security to its adopters as it facilitates those applications through its guidelines. So, let’s explore some of them.

1. Data Security & Privacy

Data Security:

• Data Security Practices: HIPAA ensures an entity follows robust data security practices through security measures like encryption, access control, Data Loss Prevention (DLP), and vulnerability management.
• Secure Development Lifecycle (SDLC) Practices: During the development cycle, it is important to ensure that security measures are integrated into the system. Since HIPAA is mandatory, it compels developers to take security measures, thereby protecting PHI throughout the lifecycle, from design to coding.
• Incident Response Plan:  HIPAA mandates an incident response plan to take swift actions to detect, contain, and mitigate data breaches. This involves procedures related to identifying breaches, notifying victims, and implementing measures to prevent any future occurrences.
• Cloud Computing Considerations: ePHIs are increasingly getting integrated with a cloud architecture that is vulnerable to breach. However, HIPAA demands the covered entities take appropriate measures like data encryption, access controls, and BAAs with cloud providers.
• Protecting Any Data with Potential for Exposure: HIPAA demands any data that has the potential to get exposed should be safeguarded by covered entities. This would include protection from any unauthorized access, use, disclosure, disruptions, modification, or destruction of data.

HIPAA Compliance:

• Handling Protected Health Information (PHI): PHI is sensitive patient information that can be used for malicious purposes. So, as per HIPAA, it is mandatory to take security precautions like encryption, access controls, and employee training.
• Business Associate Agreements (BAAs): Here, HIPAA demands a legally binding contract between the covered entity and its business associates. This ensures that even the business entities protect patient data and take measures to secure it.

2. Healthcare IT Solutions

Software & Platforms:

• EHR Software: EHR Software is created to handle patient health data, i.e., PHIs or ePHIs. Therefore, HIPAA mandates strict security to be implemented on the EHR software for keeping PHIs encrypted, role-based access controls, regular risk assessments, etc.
• Patient Portals: This protects sensitive health information and empowers patients to manage their care. HIPAA is implemented on patient portals, ensuring secure access, data encryption, and audit trails. 
• Telehealth Platforms: HIPAA compliance for telehealth platforms makes it necessary to implement security measures to protect patient data on these platforms. This includes protecting data during transit and rest, implementing access controls, integrating secure user authentication, and adhering to data privacy. The platform is required to maintain confidentiality, integrity, and availability of any patient information while providing remote services.
• Medical Imaging Software: This software is used to capture, store, analyze, and share medical images + data. Therefore, this data is patient health data that needs to be protected as per HIPAA by creating access controls, encryption, etc.
• Health Data Analytics Tools: HIPAA compliance for health data analytics tools requires robust security measures. This includes data encryption, access controls, and Business Associate Agreements (BAAs) with vendors. Tools must ensure the confidentiality, integrity, and availability of patient data during analysis and reporting while adhering to HIPAA's strict privacy regulations.

Emerging Technologies:

• Artificial Intelligence (AI) and Machine Learning: While implementing AI/ML, HIPAA demands the covered entities to safeguard PHI.
• Wearable Technology: HIPAA is applied to the data collected from wearable devices. As per it, the development company that aids in data transit, covered entities, and business associates are required to protect the health data of the user.
• Blockchain Technology: The application of blockchain in itself minimizes the risk of data breaches and unauthorized access. However, integrating HIPAA can facilitate an additional layer of secured sharing of data among authorized entities that maintain patient control over their information. 

3. Healthcare IT Services

• IT Support & Maintenance: IT Support & Maintenance has a huge role in implementing HIPAA. They provide services like system monitoring, regular maintenance, data backups, access control, etc. that safeguard electronic protected health information (ePHI). This ultimately helps prevent unauthorized access, breaches, and related data loss.
• Software Development for Healthcare Clients: HIPAA is implemented on the SDLC lifecycle to ensure that best practices are followed, such as risk assessments, secure coding practices, robust data encryption, and granular access controls. With HIPAA, these best practices are implemented at the onset of the development cycle.
• Working with Healthcare Clients: While working with healthcare clients, it is important for the covered entities to adhere to HIPAA by providing comprehensive employee training, conducting background checks, demanding full adherence from subcontractors, and implementing an incident response plan. By following this, patient data remains secure while the covered entity gains more trust from the client.
• Cloud Service Providers: By fulfilling these requirements, CSPs enable healthcare organizations to securely leverage cloud technologies while upholding the stringent data privacy and security standards mandated by HIPAA. CSPs or Cloud Service Providers are a major part of data handling in healthcare. So, they are required to sign BAAs (Business Associate Agreements) to implement security measures like data encryption and access controls to patient data, which are enabled through HIPAA.

4. Organizational & Operational

• Third-Party Relationships: Healthcare organizations should meticulously demand adherence to HIPAA while creating third-party relationships. This necessitates factors like third-party vendors' compliance assessment, BAAs, continuous monitoring, etc. By managing these relationships, the covered entities can easily mitigate the risks of data breaches and safeguard the security and privacy of patient information. 
• Employee Data: Employee data doesn’t directly impact patient health data. However, it can indirectly impact HIPAA compliance. So, the covered entities are required to protect employee data by implementing security measures like thorough background checks, strong access controls, and regular awareness training for employees.
• Customer Data: Customer data comprises PHIs and e-PHIs. Therefore, it is important to protect the data provided by the patient, such as name, address, Social Security Number, etc., as per HIPAA, as this data can be used for malicious purposes.
• Training and Awareness: Training employees for HIPAA is essential for maintaining compliance. Therefore, it is important to conduct awareness programs that train employees on the responsibilities of protecting ePHI and the consequences of non-compliance.
• Research and Development: Information from PHIs and ePHIs are primary sources for research and development. However, HIPAA ensures that this isn’t done without patient consent and that it is secured by the research entity. Although there are certain exceptions where such entities can use these PHIs, the conditions are clearly outlined by HIPAA.
• Telehealth Integration: HIPAA mandates that telehealth platforms must prioritize patient privacy and data security. This includes secure video conferencing, encryption of patient data during transmission and storage, and robust access controls to protect sensitive health information.

How to be HIPAA Compliance Ready? - For IT and Software Development Company

Adhering to HIPAA data compliance can be tricky, especially if someone is doing it for the very first time. In most cases, a software development company or even the IT sector would generally act like a business associate. So, to get business from the healthcare industry, they need to be compliant with HIPAA since collecting PHIs is the primary objective while developing healthcare software, especially while developing EHR (Electronic Health Record) software. 

Stating this, we have mentioned below a few easy steps to become compliant with HIPAA for mobile app development, software development, and IT consultation.

HIPAA Compliance for Mobile App Development

Here are the steps to achieve HIPAA compliance for mobile app development:

1. Conduct a HIPAA Risk Assessment

Determine the type of Protected Health information that will be handled. For example, patient names, diagnoses, treatment plans, etc. After that, evaluate the associated threats and vulnerabilities, such as data breaches, unauthorized access, etc.

2. Implement Strong Security Measures

Once the data at threat is recognized, it is essential to implement security measures like data encryption, access controls, secure data storage, regular security audits, and penetration testing. 

These security measures are required to be taken for both PHI at rest and in transit. For access controls, multi-factor authentication, role-based access, and device restrictions. Plus, it is also important that the CSPs (Cloud Service Providers) are compliant with HIPAA + regular security audits to identify and address vulnerabilities.

3. Ensure Data Integrity and Availability

At this step, the mobile app development company is required to implement robust data backup and disaster recovery plans to protect against data loss. Also, it is important to regularly patch and update the system for security.

4. Adhere to HIPAA Administrative Safeguards

Now, create a comprehensive plan to implement organizational policies and procedures for handling ePHI. And create a training plan for all employees to handle ePHI. Also, if you work with third-party vendors or subcontractors then ensure that they have signed BAAs that include HIPAA obligations.

5. Obtain Necessary Certifications and Audits

Try to gain relevant certifications like HITRUST to showcase your commitment to HIPAA compliance. Also, regular internal and external audits should be conducted to identify spaces that are not compliant with HIPAA regulations.

6. Maintain Ongoing Monitoring and Evaluation

Start filling in the gaps that are required as per HIPAA in terms of technology, regulations, and organizational needs. And stay updated as per the latest guideline changes made by the Department of Health and Human Services (HHS).

HIPAA Compliance for Software Development

To adhere to HIPAA compliance for software development, follow the steps below:

1. Establish HIPAA Requirements

Before making any changes, it is important to familiarize yourself with key rules of HIPAA,i.e., Privacy Rule, Security Rule, and Breach Notification Rule. Also, learn whether your organization comes under Covered Entity or Business Associate as per HIPAA regulation.

2. Perform a Risk Assessment

Now, start addressing the potential risks and vulnerabilities related to ePHI. Make a document of the findings and start creating a mitigation plan. The plan should ensure that your organization ensures compliance with HIPAA Security Rule’s risk analysis requirements.

3. Design and Develop Secure Software

At this stage, you need to establish key security of the software. This would include following practices like access controls, data encryption (preferably AES-256), maintaining logs of access and modifications of ePHI, strong authentication mechanism (MFA), and use of safe protocols like HTTPS and OAuth 2.0.

4. Develop and Enforce Policies

Now establish clear policies around data access and usage, incident response, and breach reporting, and conduct regular training of employees for HIPAA compliance. This would provide a standardized plan for the organization. 

5. Sign Business Associate Agreements (BAAs)

Sign BAAs with all the third-party vendors who have access to or process ePHI on their end. This would ensure that no data leakage happens as they are also accountable for losing it, and the patient information remains protected.

6. Conduct Regular Audits and Penetration Testing

Start testing the system for vulnerabilities like lack of encryption, weak passwords, outdated security patches, etc., periodically. This would make sure that you are compliant with HIPAA rules by conducting internal and external audits. 

For the internal audit, try to identify areas that have a higher chance of having vulnerabilities and then use methods like vulnerability scanning, penetration testing, etc., to document them. And, if we talk about external audits, hire a qualified auditor, provide the auditor access to your systems, and ask him for well-documented findings.

7. Implement Data Backup and Disaster Recovery

Now, get secure backup solutions for the ePHI. This would ensure that in times of an incident, disaster recovery can be executed to restore operations before the incident.

8. Train Your Team

Train all your teams regularly to keep HIPAA compliance intact. This would include developers, testers, and the entire support staff. To do so, you can provide training regarding:

• What are HIPAA regulations?
• Definition and examples of PHI and ePHI.
• Explain the rights of patients in terms of controlling data.
• Secure coding practices that protect PHI from SQL injection and other threats.
• Tools and techniques to identify vulnerabilities.
• Self-paced modules and quizzes.

9. Monitor and Maintain Compliance

Continuously monitor and stay updated with any changes that come with the HIPAA regulations. Also, check your systems for any sort of unauthorized access or suspicious activities. This can be achieved through periodic risk assessments and compliance reviews.

10. Document Everything

Start maintaining thorough documentation of the efforts made for compliance, policies, risk assessments, and the remedies taken. The documentation should be easily available to be audited and investigated for further improvements. 

To make the process of documentation easy, you can even use software like GRC (Governance, Risk, and Compliance) Platforms, Document Management Systems (DMS), and HIPAA-Specific software. These categories of tools also have predictive analytics, so you can analyze historical data, predict future breaches, track compliance metrics, etc.

HIPAA Compliance for the IT Sector

HIPAA is only subjected to a software company operating in the healthcare domain and that too if the company handles ePHI. Stating this, below are generic steps to get HIPAA compliance for the IT sector in the guide of an IT organization.

1. Conduct a HIPAA Risk Assessment

The IT organization looking to become compliant with HIPAA should begin with finding vulnerabilities in their IT service or products that handle PHIs. This includes handling, processing, and transmission of protected data. Evaluation will determine potential threats and help form policies and methodologies to secure PHIs from data breaches, unauthorized access, and any accidental disclosures.

2. Develop a HIPAA Compliance Plan

Now, start creating clear policies and procedures to handle ePHI. This would include data access, usage, disclosure, and security measures. After this, HIPAA compliance officers should be designated to define roles and responsibilities for all employees clearly.

3. Implement Technical Safeguards

Begin with forming technical safeguards for the patient health data. These would include the implementation of strategies like:

• Data Encryption: Implement strong encryption for the ePHI that is at rest and in transit.
• Access Controls: Implement robust access controls, including multi-factor authentication, role-based access, and device restrictions. 
• Network Security: Secure your network infrastructure by implementing firewalls, intrusion detection systems, and other security measures.

4. Implement Physical Safeguards

Now, create physical safeguards to secure work areas where the ePHI is stored or accessed. And for the connected devices, implement measures to protect devices from any loss, theft, and unauthorized access.

5. Implement Administrative Safeguards

At this step, establish a comprehensive plan for HIPAA training to let them understand how to handle ePHI. After that, create BAAs with other entities that work with the ePHI, and develop an incident response plan.

6. Ongoing Monitoring and Maintenance

Conduct regular internal and external audits along with risk assessments. To assess internally, you can audit access controls, transmission security, device and media controls, etc. To get an external perspective, you can get a HIPAA Security Rules audit, penetration testing, compliance adherence audits, etc., in order to identify gaps in compliance and address them.  Stay updated as per the latest changes in HIPAA regulations, guidance, and best practices.

Common Challenges and Solutions Associated With HIPAA

Adopting HIPAA compliance guidelines requires adhering to multiple factors related to data security. Plus, there are multiple spaces from where the data can still be leaked, turning them into consistent issues or challenges, as discussed below. 

Improper Risk Assessment

In an independent research by Check Point, researchers found a 75% increase in cyberattacks in Q3 of 2024 as compared to 2023. Therefore, conducting risk assessments becomes a consistent challenge as the frequency and tactics continually evolve. 

To mitigate this, it is important to go beyond the basic checklists and take a deep dive into the details of the system, data flows, and potential threats. Also, upgrade your assessments as per new vulnerabilities and attacks, and make use of risk assessment tools and methodologies.

Inadequate Disposal of PHI

There is no clear timeline provided by HIPAA after which PHIs are to be disposed of, but HIPAA does have a retention period of 6 years.

However, many organizations lack clear policies and procedures to do the task while, at times, employees are not adequately trained. So, there are several ways these PHIs can be disposed of. These are:

• Simply shredding the paper records
• Only deleting files from the computer
• Discarding electronic records in a dumpster
• Theft of laptops, mobile devices, and other electronic equipment that contain PHI   

To safeguard against inadequate disposal, develop secure disposal methods like degaussing, physical destruction of drives and other devices, and overwriting existing data multiple times with new data using tools. Further on, you should provide thorough employee training and regularly review and update the policies.

Device Security

It may not seem like a lot, but as per the HIPAA Journal, around 16 devices carrying PHIs were either lost or stolen. The loss of data would depend on whether the devices were encrypted or not and the intent of the person who stole the data. However, it is still an issue that can expose tonnes of personal patient data. 

To protect devices and stay compliant with HIPAA, it is important to use strategies like Encryption, Access Control, Device Management, Physical Security, and Employee training. This would ensure that the data is still not compromised even if a device is lost.

Insufficient ePHI Access Controls/Authorization Issues

Another huge challenge that organizations on the road face to becoming HIPAA-compliant is insufficient access controls/authorization. These could lead to unauthorized access, data breaches, and compliance violations.

Employees either with excessive access or if there are weak access controls in place could lead to data breaches. Failing compliance can even violate HIPAA and lead to penalties.

To ensure that this doesn’t happen, covered entities can utilize strong authentication, role-based access control, regular audits and monitoring, employee training, and an incident response plan in place.

Data Breaches

HIPAA Journal stated that there were around 100,000,000 individuals affected after an attack on Change Healthcare, Inc. where ePHI data got exposed. In fact, there were incidents with Ascension Health, Kaiser Foundation Health Plan, HealthEquity, Concentra Health Services, etc., who had to bear data breaches in 2024 affecting millions of individuals. 

The easiest way to fix this issue is to become compliant with HIPAA and update yourself on any changes that happen. Additionally, you can always look out for new threats and come up with a solution to avoid an intrusion, and even if that happens, then an incident response plan in place would save you.

Vendor Oversight

Vendor oversight is a critical issue that can potentially expose PHIs. Covered entities work with multiple vendors for a multitude of tasks. However, these vendors must be HIPAA-compliant if they work, modify, process, or do any operation on PHIs. There have also been incidents where covered entities have ignored them, leading to consequences like data breaches. So, some of the strategies that can be taken to fix this issue are:

• Careful evaluation of vendors to check whether they comply with HIPAA’s privacy and security standards.
• Vendors must be continuously monitored to ensure they don’t violate security standards.
• Regular audits and data security practices to identify and address vulnerabilities.

Integration of Other Similar Laws

Several challenges arise when covered entities try to integrate HIPAA with other similar laws. Some issues involve managing privileged access, integration with legacy systems, inconsistent standards, jurisdictional conflicts, expertise gaps between providers and users, client control, etc.

To tackle this challenge, the covered entities can go several routes:

• Create binding agreements 
• Use frameworks like the NIST Cybersecurity Framework
• Data mapping and classification of each law’s requirements
• Adoption of technology platforms that meet the requirements of multiple legal frameworks, etc.

Inadequate Staff Training

Inadequate staff training can lead to several other challenges like lack of clarity in requirements, outdated knowledge, human errors, etc. This could have a serious impact as there are many employees who work with e-PHIs on a daily basis. The best way to mitigate this problem is by creating comprehensive training programs, role-based training, interactive methods, continuous education, and measures to maintain accountability of the employee.

Neglecting Business Associate Agreements (BAAs)

As stated earlier, BAAs are documents signed by business associates stating that they will comply with HIPAA. It is necessary so that even the business associates are compelled to work with them within the realm of HIPAA. However, there are times when these are neglected and have led to data breaches. 

For instance, in 2015, the Medical Informatics Engineering (MIE) breach happened. In this breach, around 3.9 million individual PHIs were exposed. Later on, the investigation revealed that MIE had not established BAAs with its subcontractors who had access to the PHI.

To resolve the issue, consider signing up BAAs with vendors and subcontractors a necessary task. This would make sure that even if the data got exposed, it would keep you out of the penalty.

Future Trends and Updates of HIPAA

Now, let's check out some of the future trends and updates that happened with HIPAA the previous year and this year. 

Updates:

• In April 2024, the Reproductive Health Privacy Rule was issued by HHS to modify HIPAA. The rule aimed at protecting information related to reproductive healthcare and the deliverance of information by similar reproductive health services.
• The HHS Office for Civil Rights (OCR) actively enforced HIPAA regulations, and American Medical Response was penalized by $115,200 for not providing timely records of patients in August 2024.
• In 2024, the data related to substance use disorder patients were aligned more closely as per HIPAA to streamline and share patient information while maintaining privacy.
• In December 2024, the HSS proposed significant changes to the HIPAA Security Rule to strengthen cybersecurity measures. These modifications include mandating multifactor authentication, network segmentation, requiring comprehensive risk assessments, detailed documentation, etc.

Future Trends:

• With rising cases of cyberattacks each year targeting healthcare organizations, there will be an emphasis on implementing more robust cybersecurity measures to protect patient data. Future regulations can also mandate advanced security protocols and perform regular compliance audits.
• As technologies like artificial intelligence and telehealth increase, it can be anticipated that HIPAA regulations will evolve, addressing unique privacy and security challenges.
• There is an ongoing trend to harmonize HIPAA as per state-specific health data privacy laws. This can lead to a more cohesive regulatory environment, especially when apps and digital platforms collect health and fitness data.

Software Development Best Practices - As Per HIPAA Compliance

To adhere to HIPAA data compliance during the software development lifecycle (SDLC), there are best practices that you can follow. Here are some of the best practices for SDLC that we believe you should follow.

1. Data Integrity and Validation

• Validation of Data: Aim to implement a validation mechanism that ensures PHI is accurate and modified by an authorized person.
• Checksum and Hashing: Use algorithms like checksums or hashing to detect any corrupted data or unauthorized changes.

2. Secure Data Transmission

• Transport Layer Security (TLS): Make sure the transmitted data over the networks is encrypted using protocols like TLS. This would prevent any sort of interception, in most cases, by any unauthorized party, even on a public network.
• Usage of Secure Protocols: Use secure channels such as HTTPS or TLS. These help protect data integrity while it is being transmitted for use.

3. Access Control and User Authentication

• Unique User Identification: Provide unique identifiers to ensure you track access and maintain accountability.
• Role-Based Access: Utilize role-based access controls to make sure users can only access information relevant to their roles.
• Multi-Factor Authentication (MFA): Use MFA to add a further layer of security during the login process.
• Third-Party Compliance: Make sure that all your vendors and partners who are or will be handling PHI have signed BAAs to comply with HIPAA regulations.

4. Encryption and Data Security

• Encryption in Transit and at Rest: Ensure that the PHI is encrypted during transmission and storage to prevent unauthorized access.
• Strong Encryption Protocols: Use industry-standard encryption like AES-256 to secure PHI data.

5. Incident Response and Disaster Recovery

• Response Procedures: Document every procedure taken to respond to a security breach involving PHI for future reference.
• Regular Drills: Conduct regular incident response drills to ensure the staff remains ready and effectively implements response strategies.
• Disaster Recovery Plan: Create a disaster recovery plan and regularly test it to foresee whether it will work during system failures or not.

6. Employee and Vendor Training/Compliance

• HIPAA Training Programs: Regularly train your employees with updated HIPAA requirements.
• Phishing Simulations: Create phishing simulations to educate employees on recognizing any kind of attack through emails, messages, etc.

7. Audit and Logging

• Comprehensive Logging: Create detailed logs of any activity related to access and modifications of PHI.
• Internal Audits: Conduct internal audits to ensure compliance with HIPAA requirements and identify possible vulnerabilities.
• Third-Party Assessments: Get external experts to conduct comprehensive evaluations and gain unbiased insights.

8. Minimization and Anonymization

• Limit Data Collection: Only collect minimum data from PHI for the intended purpose, reducing exposure risk.
• Anonymization Techniques: Use data anonymization methods when the patient's identity is not necessarily required.

9. Secure Remote Access

• Virtual Private Networks (VPNs): Use VPNs for secure remote access to ePHIs available on cloud systems.

10. Business Continuity and Contingency Planning

• Contingency Planning: Create a contingency plan to make sure business-critical processes remain operational even during PHI emergencies.
• Regular Backups: Take routine backups of the PHI to recover data after an incident.

How MobileAppDaily Can Help?

At MobileAppDaily, our aim is to create a space that works as a single-point resource for everything IT. This is the reason we made this article to help our primary audience with the topic at hand. However, as we have aimed, our offerings are not limited to editorials. Instead, we also create directories of top companies like Top Healthcare Web Design Companies, Top AI Development Companies in Healthcare, Top Healthcare Software Development Companies, etc.

Besides that, we also curate a lot of other types of content. For example, Top Products Listicles, Special Reports, Exclusive Interviews, Social Media Content, etc. Covering this variety of content not only pushes us toward our aim but also educates our audience to succeed and stay consistent in the long run.

Conclusion

HIPAA historically has been a compliance that curbed practices like “Job Lock.” It has actively kept a barricade between intruders and healthcare personal information. This has not only protected patients’ personal information but has also curtailed the number of breaches, considering the exponential growth in internet connectivity and the number of users. Saying this, we hope we may have been able to help you with HIPAA regulations and compliance. And, if you want more of such resources check out our blogs’ segment.