Cyberattacks preying on sensitive data can paralyze an entire industry in an instant, and Healthcare is unfortunately not immune to such a grievous threat. A study by HIPAA journal has found that 706 healthcare data breaches have been reported from August 2020 to July 2021—compromising sensitive information of nearly 45 million individuals. This ominous trend is particularly disconcerting for healthcare providers as an attack of this nature can endanger many mission-critical operations—the failure of which can quickly devolve into a matter of life and death for patients.

To maintain the confidentiality and security of sensitive information against looming cybercrimes, healthcare providers must take the necessary steps to bolster their software development with HIPAA compliance in mind. But what is HIPAA, and how would it help combat the risks of security breaches? 

This article will dive into the HIPAA law and its role in healthcare software development.

What is HIPAA?

Enacted in 1996, the Health Insurance Portability and Accountability Act (HIPAA) is a federal law that provides healthcare institutions and their associated businesses with standardized regulatory procedures on how to engage and protect a patient’s sensitive health information. This law and all the subsequent regulations are under the supervision and enforcement of the US Department of Health and Human Services (HHS).

In legal contexts, any organizations that provide healthcare and other closely related services are known as covered entities. This term encompasses not only healthcare providers like hospitals, clinics, and pharmacies but also health plans, including insurance companies and government programs like Medicare, as well as clearinghouse organizations that verify medical insurance claims. 

Certain organizations outside the realm of healthcare also fall under the purview of HIPAA, provided the services they render to covered entities require access to and use of protected medical information. These organizations—legally referred to as business associates—may comprise, among others, software development firms, cloud service providers, lawyers, and collection agencies.

Protected Health Information (PHI)

PHI refers to any identifiable personal data collected by a healthcare professional that contains information regarding an individual’s health status, provision of healthcare, and payment related to such care. This information includes primary demographic data, insurance details, medical histories, test and laboratory results, and other data excerpted from medical consultations.

HIPAA rules

There are five main components of HIPAA regulations, each addressing specific provisions and regulatory frameworks.

Privacy rule

The Privacy Rule regulates the use and disclosure of PHI by covered entities in their capacity to facilitate quality care and improve public wellness. It outlines the limits and conditions on what information healthcare providers can use without an individual’s written consent. To protect the patients’ privacy, the covered entities must disclose only the minimum amount of information required for care coordination purposes, from treatment to payment, as well as activities in the realm of public interest like medical research. 

The Privacy Rule also affords individuals full rights over their PHI—enabling them to examine and obtain a copy of their health records, ask healthcare providers to transfer such records to the authorized third parties, and request for corrections, if necessary.

Security rule

While the Privacy Rule governs the patients’ rights to their medical records, the Security Rule, in contrast, concerns the protection of health information stored, maintained, and transmitted in electronic form. To fulfill the obligations set forth above, the HIPAA-covered organizations must ensure the safety, confidentiality, and integrity of the electronically stored information by adhering to the following safeguards:

1. Technical safeguards pertain to the technology and tools implemented in creating the procedures and mechanisms to protect and control access to ePHI (electronic protected health information).
2. Physical safeguards refer to any tangible measures, policies, and procedures taken by covered companies to ensure the safety and integrity of infrastructure, facilities, and devices where electronic information systems operate—the location of which can be an on-premise data server, a cloud platform, or a remote data center.
3. Administrative safeguards entail all the managerial practices and processes involved to enforce the existing security measures and eliminate any risks of potential ePHI breaches. To that end, the law mandates healthcare providers to appoint one or more Privacy and Security compliant officers to oversee organizational compliance, perform periodic security audits, and provide HIPAA-related training for employees.

Enforcement rule 

The Enforcement Rule bears any provisions relating to liability assessments, investigations, and monetary penalties in the event of a compliance breach. The penalties imposed may vary from as little as $100 per violation to a maximum of $1.5 million per annum for violations of an identical provision. Civil litigations from the affected individuals and criminal charges may ensue if a covered entity commits the breach due to willful negligence.

Breach notification rule

The Breach Notification Rule requires covered entities and their business associates to notify any relevant parties following an incident of a data breach. These parties comprise the affected individuals, the Secretary of HHS, and, in circumstances where the breach affects more than 500 people, the media.

Omnibus rule

Introduced in 2013, the Omnibus Rule covers all the grounds that the previous rules haven’t addressed. The rule extends the scope of HIPAA obligations to associated partners and subcontractors of healthcare organizations. It has also amended and implemented several new provisions under the HITECH Act (Health Information Technology for Economic and Clinical Health).

HIPAA-compliant checklist for healthcare software development

When building your custom healthcare application, it is essential to observe strict adherence to HIPAA compliance standards, particularly regulatory guidelines outlined in the Security Rule, to avoid potential breaches. Given the expansive scope and obligations under HIPAA, we have compiled a checklist to help you identify areas of compliance in your software development endeavor.

User authentication

A healthcare software program must implement a robust verification procedure to corroborate the identity of the party attempting to access the protected data. Assigned user identifications at work may range from a single-layer password system to multi-factor biometric authentication. For enhanced security, the software program may further limit its access via automatic log-off after a period of inactivity, file encryption mechanisms for information during transit or at rest, and geo-based authentication tailored exclusively to approved networks or devices at distinct locations.

Data integrity

To ensure PHI integrity, the software must assign role-specific authorizations to different functions within the organization. For example, a hospital’s EHR (Electronic Health Record) may grant medical practitioners full access to the patients’ health information to assist with care delivery. Meanwhile, receptionists only deal with specific subsets of PHI, like names and dates of admission, for logistic and administrative purposes. To further eliminate risks of interference, HIPAA-covered organizations may perform access control measures by restricting entries to on-premise facilities and prohibiting the use of any unauthorized devices in the workstations.

System audit

Healthcare organizations must conduct regular risk assessments and system audits across operations to demonstrate continued compliance with HIPAA regulations. To expedite the process, you can deploy a software program to assist with proper documentation and tracking of all activities for inspections. With more streamlined data management, you can create comprehensive reports to assess the effectiveness of your regulatory conformance—obtaining greater control and protection of sensitive information in the process.

Contingency plan

Under the Security Rule, every covered entity must have an emergency procedure in place to alleviate the fallouts from data breaches and other unforeseen incidents. This contingency plan specifies the necessary steps to resume critical business operations and retrieve and secure the compromised data. In the aftermath of an attack, covered entities must implement subsequent remedial measures to bridge any security gaps, including accessing ePHI backups to replace any corrupted files.

Managing partnership with business associates

Given the reputational risks and legal ramifications of noncompliance, healthcare organizations entering business partnerships with other firms typically necessitate the candidates to have a comprehensive knowledge of HIPAA regulations and familiarity with its scope of application. Therefore, any third party with access to ePHI must sign a contract agreement with clauses attesting to its due diligence to fully abide by HIPAA regulations. 

Creating a HIPAA-compliant digital application is critical in eliminating cybersecurity threats and avoiding financial sanctions levied by the government. With over a decade of experience empowering global clients with digital software innovations, we from Asahi Technologies can help you develop a HIPAA-compliant software solution with robust data security to bring quality care closer to those in need. Contact us below for a complimentary consultation to get started.

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