Outsourced HIPAA Compliance
Outsourced HIPAA compliance is when a HIPAA-regulated entity engages external consultants to manage part, or all, of the organization’s HIPAA compliance obligations in order to support an existing in-house compliance team, as an alternative to building an in-house team, or in response to a HIPAA security incident.
Outsourced HIPAA compliance services can be structured in various ways. Some external consultants function as a full-service operation, effectively replacing – or becoming an extension of – the organization’s in-house compliance team. Others offer on-demand consulting for specific compliance issues, or – for example – to help an organization recover from a HIPAA security incident.
By outsourcing HIPAA compliance, HIPAA-regulated entities benefit from the expertise of professionals who are up to date with regulatory requirements and industry best practices. This approach can also be cost-effective for smaller organizations that might not have the resources to build an in-house compliance team or employ key workforce members such as a cybersecurity specialist.
The Core Components of Outsourced HIPAA Compliance
External consultants can vary in what services they provide depending on their area(s) of expertise. However, outsourced HIPAA compliance generally consists of five common core components.
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Risk Assessments
HIPAA covered entities and business associates are required to conduct regular risk assessments and evaluations in order to identify potential risks and vulnerabilities to the confidentiality, integrity, and availability of Protected Health Information (PHI). In some organizations, even identifying where PHI is created, received, and maintained, or how it is transmitted can prove complicated.
Outsourced HIPAA compliance consultants use state-of-the-art risk management software and methodologies to conduct the necessary assessments. They evaluate where data may be exposed, identify potential risks and vulnerabilities, and recommend remediation strategies. By doing so, they help organizations mitigate the risk of costly data breaches and ensure they are always prepared for regulatory audits.
Policy Development and Implementation
HIPAA covered entities and business associates are not only required to comply with all applicable HIPAA Administrative Simplification Regulations, but also any other federal or state regulations that apply to their operations. Sometimes there can be conflicts between HIPAA and other regulations when the other regulations require more stringent protection of PHI or provide individuals with more rights.
Creating and maintaining policies and procedures that meet the requirements of all applicable regulatory requirements requires an understanding of how federal and state regulations interact with each other. External compliance experts can craft policies that reflect both the letter and spirit of applicable regulations and assist with updating policies as regulations evolve or as the organization adapts to new technologies.
Education and Training Programs
One of the most important elements of HIPAA compliance is ensuring that all members of the workforce understand the basics of HIPAA. Unfortunately, not all HIPAA-regulated entities have the resources to comply with the full HIPAA training requirements and often only provide role-based policy training and generic security awareness training – rather than security awareness training in accordance with the General Requirements of the HIPAA Security Rule.
Outsourced HIPAA compliance services develop comprehensive training programs and customized workforce training programs tailored to an organization’s specific needs. These programs educate workforce members on the basics of HIPAA in the context of data security best practices, recognizing potential threats, and proper incident response protocols, and can be used for annual refresher training in years when material change training is not required.
Continuous Monitoring and Incident Management
Depending on the level of involvement, external consultants can take on different levels of compliance monitoring roles. Those who work onsite as a replacement for, or as an extension of, a HIPAA compliance team can monitor workforce compliance with policies and procedures, while those who work remotely are likely to implement software that monitors system activity to look for usual behaviors that could represent a threat to the security of PHI.
In most cases, outsource HIPAA compliance consultants will also manage HIPAA security incidents – either by taking responsibility for tracking, handling, and responding to HIPAA security incidents, or by guiding the in-house compliance team through the processes of documenting security incidents, determining whether the incidents qualify as a notifiable data breach, and – if so – ensuring breaches are notified in a timely manner.
Documentation and Audit Readiness
An important part of HIPAA compliance is documentation – not only documenting risk assessments, policies, procedures, workforce training, and incident reports, but also versioning each document, updating each document as necessary, and ensuring secondary documentation is updated in line with primary documentation updates – for example, when a change to a privacy policy affects an organization’s Notice of Privacy Practices.
Complete, accessible, and up to date documentation is essential in the event of a compliance investigation or audit. HIPAA-regulated entities that are unable to provide the necessary documentation when requested by HHS’ Office for Civil Rights could face significant sanctions. In 2021, Peachstate Health Management LLC settled an alleged HIPAA violation relating to a lack of documentation with HHS’ Office for Civil Rights for $25,000
Might Outsourcing Work for Your Organization?
As well as being able to outsource some or all of an organization’s HIPAA compliance obligations, HIPAA-regulated entities can take advantage of consultants’ services on a time-limited basis. This can enable organizations to jump start their compliance efforts until such time as they are ready to take over responsibility for HIPAA compliance, or gradually assume responsibility for HIPAA compliance over time.
HIPAA covered entities and business associates that are interested in cost-effective methods of enhancing their security postures are advised to reach out to external consultants in order to assess whether the specialized expertise being offered can be of benefit to the organization. Even if the advice and support acquired through outsourced HIPAA compliance only results in one less data breach, the effort will have been worthwhile.


