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Decoding the HIPAA Omnibus Rule: A guide for HealthTech professionals

HealthTech is booming — which means incredible innovations and also new cybersecurity vulnerabilities. And government regulators are moving quickly with new recommendations on data security. It’s not a new scenario. 

When healthcare and technology collide

The dynamic intersection of technological advancement and regulatory compliance in the healthcare sector has always presented both opportunities and challenges. The HIPAA Omnibus Rule, a critical amendment to the Health Insurance Portability and Accountability Act (HIPAA) of 1996 introduced in 2013, stands as a key measure in this evolving landscape. This rule extended HIPAA's coverage in response to the complex web of digital interactions and third-party engagements that characterize modern healthcare.

With the U.S. Department of Health and Human Services (HHS) continually advancing cybersecurity initiatives to fortify the healthcare sector's defenses, the imperative for healthcare providers, insurers, and their business associates to stay abreast of compliance requirements has never been more critical. 

Navigating this complex regulatory environment requires more than just awareness; it demands robust, adaptive strategies for compliance. Tools and platforms like Strike Graph play an indispensable role in this context, offering streamlined solutions for meeting and demonstrating compliance with the HIPAA Omnibus Rule and other evolving regulations. In this era of rapid HealthTech innovation, integrating comprehensive compliance frameworks with cutting-edge technology is key to safeguarding patient information and ensuring the seamless operation of the healthcare industry.

The HIPAA Omnibus Rule unpacked

Introduced to strengthen and expand HIPAA's privacy and security protections, the Omnibus Rule made significant adjustments to how protected health information (PHI) is handled across the healthcare and tech industries. 

Expanded accountability

The rule expanded HIPAA’s reach to include business associates of healthcare providers, insurers, and other HIPAA-covered entities. These business associates, such as subcontractors and data storage companies, are now directly liable under HIPAA.

Stringent breach notification standards

The Omnibus Rule introduced a more stringent standard for breach notifications, making it obligatory for covered entities and business associates to report any breach of unsecured PHI, unless they could demonstrate a low probability that the PHI had been compromised based on a risk assessment. 

Enhanced patient rights

Patients were granted more control over their health information under the Omnibus Rule. This includes the right to request electronic copies of their medical records and to restrict disclosures of their PHI, giving patients more autonomy and control over their personal health information.

Steeper penalties for non-compliance

The Omnibus Rule adopted a tiered penalty structure for violations, significantly increasing the maximum penalty for willful neglect of compliance obligations. Penalties can now range from $100 to $50,000 per violation depending on a business’s level of willful neglect and due diligence, with an annual maximum cap of $1.5 million per violation.

The challenge of HIPAA Omnibus Rule compliance

One of the unique challenges of adhering to government regulations, such as HIPAA, lies in their broad and outcome-focused nature. Unlike security frameworks like ISO 27001 or SOC 2, which delineate precise actions and controls for compliance, regulations like HIPAA outline the outcomes that must be achieved without specifying a clear pathway to get there. This distinction creates a significant hurdle for organizations. It's not enough to simply claim compliance with HIPAA — companies must be able to prove it.

Proving compliance in this regulatory environment demands a two-pronged approach: external verification and robust internal reports. External verification can come in various forms, such as audits by independent third parties, certifications, and other attestations that objectively assess and confirm an organization's adherence to regulatory requirements. 

Internally, generating comprehensive reports that detail compliance processes, controls, and the effectiveness of those controls is essential. These documents not only serve as proof of compliance for regulators and auditors but also play a crucial role in identifying areas for improvement within the organization's compliance framework.

Turn HIPAA into a competitive advantage with Strike Graph

In the past, accomplishing a thorough internal and external verification process of your HIPAA compliance program was expensive, slow and stressful. And, because it required hiring and managing multiple consultants and auditing firms, it was out of reach for many small and medium sized businesses.

Strike Graph has changed the math. Our all-in-one compliance and certification platform gives you all the tools you need to achieve HIPAA compliance — and all the tools you need to verify your compliance, both internally and externally. 

Customizable reporting 

Strike Graph's advanced reporting capabilities allow organizations to generate in-depth reports tailored to their specific compliance needs. This functionality not only saves valuable time and resources by automating what would typically require extensive manual effort but also ensures a high level of accuracy and detail that is critical for internal verification. Organizations can confidently assess their compliance status, identify areas of improvement, and implement necessary changes with precision and ease.

HIPAA certification

For external verification, Strike Graph's HIPAA certification offers a clear and authoritative validation of compliance. Our certification process is designed to be thorough yet efficient, providing organizations with a definitive badge of compliance that is recognized and respected across the healthcare industry. 

Leverage your HIPAA compliance to boost revenue

Strike Graph’s HIPAA certification isn’t an empty piece of paper — it’s a trust asset. Proof that your company can be trusted with sensitive health information. When companies and patients are making decisions about who to trust with their data, your HIPAA certification will put you ahead of the competition.

As the HealthTech industry and the regulations it drives continue to advance, Strike Graph will remain at the forefront, offering innovative, AI-enabled solutions that address the evolving challenges of security compliance. 

Want to see what a difference Strike Graph can make for your company’s HIPAA efforts? Schedule a demo and we’ll give you a tour, or open a free account and take a look around yourself. 

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