Digital technology has brought tremendous growth and opportunity to the healthcare industry. Major drivers of this growth include an increasing number of integrated solutions across digital technology platforms and the migration of existing healthcare solutions to cloud-native services. These developments make it easier for clinicians to access patient data quickly and securely while reducing operational costs.

The Health Insurance Portability and Accountability Act (HIPAA) was created to ensure healthcare providers and organizations protect patient confidentiality and store health-related data securely. This act governs the use of any electronic means to store, share, manage or process personal or protected health information (PHI). That means any software used to communicate, manage or store PHI has to be HIPAA compliant.

Whether a healthcare organization decides to use custom healthcare software or commercially available solutions they still need to ensure they meet HIPAA requirements. Understanding HIPAA and how it may affect your practice can protect you as a healthcare provider and your organization from legal hassles and ensure you use the right healthcare software for your services.

Understanding HIPAA

HIPAA is one of the most important pieces of legislation for protecting Americans' health information. First passed in 1996, its primary purpose is to set standards and regulations for how healthcare providers store, protect, and share patient information. 

HIPAA also protects PHI confidentiality, except where records are demanded by law. Essentially, it's a safeguard against data breaches, gossip, privacy violations, fraud, identity theft, and cybercrime within the healthcare system. 

HIPAA compliance regulation applies to any type of medical software (such as electronic medical records, secure messaging platforms, practice management systems, etc.) that stores or transmits protected health information.

Who Must Comply With HIPAA Regulations?

HIPAA regulations apply to two groups of organizations, the Covered Entities, and Business Associates.

Covered Entities

These are healthcare providers, health plans, healthcare clearinghouses, and employers or any other entity that deals with personal medical data in the United States.

However, in 2013 HIPAA was expanded to cover all third parties partnering with covered entities for administrative or other business purposes - the business associates.

Business Associates

A business associate is an individual or organization that assists a "covered entity" to provide its services, including the performance of tasks that require handling protected health information. The services of a business associate could involve various industries including legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, or financial.

What Are the HIPAA Rules?

HIPAA sets several rules, policies and procedures that govern the use of software. Some of them include:

HIPAA Privacy Rule

The HIPAA Privacy Rule states the standard data protection measures all healthcare organizations must follow. It dictates how healthcare organizations and healthcare providers manage patient health information, including diagnoses, treatments, and payments, at all times. The HIPAA Privacy Rule protects patients' right to privacy. It also gives them rights over their protected health information, including rights to examine, obtain or transmit a copy of their health records to a third party.

HIPAA Security Rule

The HIPAA Security Rule covers all patient health information created, received, used, or preserved electronically. All providers of electronic health records must comply with this federal regulation or risk being fined or jailed for violations. The security rule mandates implementing specific administrative, physical, and technical protections to keep medical data from falling into the wrong hands. Also, the security rule defines acts that constitute a data breach. It outlines a set of security practices that can reduce the risk of a data breach. Some of those practices include two-factor authentication, data encryption, device security, and other security controls.

To meet the requirements of the rule, organizations must ensure they have provided the following safeguards:

Physical safeguards:  their physical facilities are safe and secure

Electronic safeguards:  electronic records are safeguarded by encryption technologies and remote access control mechanisms

Administrative safeguards:  staff training that employees and contractors receive security protocol training on handling medical data 

Technical safeguards:  Adequate risk management procedures exist, along with audit protocol and a regular HIPAA compliance checklist. 

HIPAA Enforcement Rule

The HIPAA Enforcement Rule contains guidelines for compliance and penalties for violations of HIPAA privacy and security rules. It also specifies the steps to take and the amounts to levy as civil penalties against covered entities and business associates that violate HIPAA regulations. 

The HHS Office of Civil Rights (OCR) investigates suspected HIPAA violations, and they are also authorized to declare if the covered entity or business associate complied with or violated the HIPAA Security and Privacy Rules.

The HIPAA Breach Notification Rule

The Breach Notification Rule requires organizations to promptly notify affected patients, the Secretary of Health and Human Services, and – in some circumstances – the media, when there has been a data breach.

This rule gives patients the power to act quickly and minimize possible damage arising from unauthorized use of their data. It also promotes accountability within healthcare organizations.

The Omnibus Rule

The HIPAA Omnibus Rule was a HIPAA update that put patients in control of their data. It increased the level of protection for confidential health information stored by covered entities and business associates, requiring improved safeguards for the storage, access, and transfer of such material.

The HIPAA Omnibus Rule also enabled patients to gain access to their health records easily and empowered individuals to dispute inappropriate handling of their medical data by organizations including business associates.

Strategies for Achieving HIPAA Compliance 

Ensuring HIPAA compliance for healthcare apps is no small feat. Healthcare organizations must take several measures throughout the development process and as they go to market in order to ensure complete HIPAA compliance. Here are some concerns that must be addressed.

Risk Analysis and Assessment

Every healthcare provider needs to take special care in designing the appropriate risk assessment plan based on their specific threats, needs and objectives. Acknowledging potential risks and vulnerabilities related to patient data security and general health information transmission can help organizations detect and prevent unauthorized access before it happens. 

Adopting the appropriate software development precautions and proactively adapting HIPAA compliant policies can help software development teams create software that is fit for use. Covered entities or business associates using HIPAA compliant software protect their patients and their business from several calamities.

Employee Training

Apart from the software development, organizations must also ensure their staff are ready to use the technology. An employee training program is an essential step for healthcare organizations to ensure HIPAA compliance among their employees and contractors. While HIPAA compliance standards often seem intimidating and complex, providing an education opportunity for all employees — no matter their designation or tenure — makes the process easier and keeps workers conscious of potential risks.

A comprehensive training plan will assist health workersin understanding the guidelines for physical access, secure data storage, personal health records management, and other HIPAA requirements. This will empower workers to provide services while keeping patient information safe at the same time.

Secure Access Control Measures

Keeping patient data secure is one of the fundamental requirements for ensuring HIPAA compliance among healthcare apps. Secure access control measures have proven to be a great way to meet this requirement and keep patient information safe. 

These measures include:

• Limiting access to specific users
• Implementing unique passwords for all users
• Conducting frequent audit trails to ensure integrity of data

Standard Authentication Protocol

Organizations must carefully design secure protocols that leverage trusted identities or credentials and additional layers of security measures like multifactor authentication to protect sensitive health data from unauthorized access or misuse. 

To ensure the highest level of safety, organizations need to deploy tools such as firewalls, antivirus software, and intrusion detection systems to prevent unauthorized access to sensitive information. This ensures unauthorized personnel cannot gain access while providing an extra security layer against potential malicious attempts.

Delegate Compliance to An Individual or Team

Designate an individual or team within the organization responsible for managing HIPAA compliance. This team should provide oversight and feedback on app development and management to ensure continued HIPAA adherence. 

If you have any questions or need help setting up a compliant healthcare app, the compliance team will be able to give you detailed guidance based on their expertise and experience in the field.

Security Incident Response

At its core, an effective security incident response plan is about having a clear strategy for dealing with threats to patient privacy. All organizations need to have detailed protocols covering all aspects of their IT environment to ensure HIPAA compliance; robust response plans are vital components of these efforts. It can also provide organizations with a roadmap for quickly resolving any issues or breaches that arise, helping them minimize the fallout from a potential catastrophe.

Conduct Regular Tests

Another measure to secure electronically protected health information is testing applications regularly to ensure that they are up-to-date with regulations. In addition to running tests on applications, it is important to monitor any updates or changes made to ensure that all modifications maintain compliance with HIPAA standards. 

Regular testing can make all the difference in the security and privacy of health information delivered through a digital platform – and if done right, could save an organization from hefty fines and reputational damage.

Data Backup and Recovery

By backing up critical data, organizations can recover information if there's ever an issue with the health app or its system. Backing up data also helps meet privacy and security requirements of the HIPAA Privacy Rule and Security Rule. It requires health systems to put protective measures in place to guard against unintended access or release of protected health data. 

Furthermore, regular backups will help meet audit requirements since they create an efficient way to track down data in case of disputes. Implementing these steps ensures compliance and allows organizations to provide better care services through improved efficiency and more secure data management practices.

Most Common HIPAA Violations

It's no secret that HIPAA laws are in place to protect vital medical information and restrict access by unauthorized persons. While it's a necessary evil, many people still find themselves in violation of these important rules. 

From covered entities like doctor’s offices and  hospitals to business associates such as insurance or billing companies, here are the common violations that occur while handling personal health information:

• Improper disposal of electronic health records
• Use of improper safeguards for data storage or electronically protected health information
• Excessive data exposure or disclosing more data than necessary when sending records
• Failure to keep track of patient data sharing, access, or storage
• Indiscriminate and unauthorized access to more personal health information than required for a specific purpose
• Failure to receive consent before sharing electronic health records
• Weak remote access security protocols to devices storing electronically protected health information
• Storage of patients' medical data on personal devices

This list is by no means an exhaustive one, but it clearly shows the potential pitfalls of using the wrong software misusing the right software.  

Forcura Is Your Solution for HIPAA-compliant Software

At Forcura, we have decades of experience developing and managing HIPAA compliant software. Our team of healthcare software developers test all our products extensively to ensure they meet and even exceed the required standards for privacy and security - in 2022, Forcura achieved HITRUST Risk-based, 2-year (r2) Certification. We ensure our software maintains HIPAA compliance during each new version and update. In addition to our Cloud-based platform, the Forcura Mobile Care Coordination app has special features to support enhanced communication and collaboration, including Document Capture, Wound Features, Secure Communication, Video Call, and Digital Forms Management, without violating HIPAA software compliance requirements and regulations. Our app interacts with our platform to securely store patient care images and documents. We also support care coordination with advanced analytics to help you manage your business successfully. 

Although software alone cannot guarantee HIPAA compliance, it's a critical first step in ensuring your practice is safe for you and your clients. You can schedule a demo of our platform here.