The risk management process in healthcare is complex due to the nature of the industry and factors such as the explosion in the use of technology; vulnerabilities arising from these myriads of technology leading to cybersecurity threats; and regulatory, legal, and reimbursement requirements. With the pressure to remain compliant, the healthcare industry must approach risk management from a broad perspective by implementing sound enterprise risk management (ERM) programs.
Here we provide you with a step-by-step guide to simplify your healthcare compliance and data risk security.
This guide will focus on:
A well-structured healthcare Enterprise Risk Management and compliance program is critical in the current healthcare climate. Having such a program promotes a comprehensive framework for making risk management decisions that maximize value protection, including putting in place safeguards to mitigate cybersecurity threats and sensitive data exposure or leaks. This is essential in a time of continual changes to regulatory requirements and associated audits, and penalties for non-compliance.
In reinforcing the need for corporate compliance programs in healthcare, The Office for Civil Rights (OCR) created guidelines that healthcare organizations can follow to begin to develop compliance programs that meet the requirements of the Health Insurance Portability and Accountability Act (HIPAA). The guidelines, “The Seven Fundamental Elements of an Effective Compliance Program”, outline those elements that the OCR considers essential in a corporate compliance program. The “Seven Elements” include:
In addition to meeting HIPAA requirements, these “Seven Elements” also apply to the numerous other regulatory and security requirements that healthcare organizations must comply with such as the Medicare Access and CHIP Reauthorization Act (MACRA), the Payment Card Industry (PCI) data security standard, and the Federal Information Security Management Act (FISMA).
Corporate compliance in healthcare and risk management must be organization-wide, however, there are some areas that are critical for all organizations to focus on.
Medical records can sell for 20 to 50 times more than other kinds of identity theft records. Sound compliance practices must take the dark web into account, and healthcare stakeholders should implement systems that can quickly and easily identify any compromised credentials or indications of stolen data and provide direction on actions to be taken. Read more about our Dark Web Monitoring tool.
Healthcare organizations have a multitude of sensitive data that pose a security risk, especially when being shared/accessed outside of internally protected systems. A good compliance program will include endpoint and data protection technology tools, encryption of local copies of data, and identification of sensitive data with rules governing access and distribution.
All technological tools/assets used in healthcare pose a security risk and are susceptible to vulnerability threats. Healthcare security managers must implement consistent and regular monitoring and scanning of these assets to determine whether any have been compromised.
Third-party vendors and contractors perform critical functions for the healthcare industry and are privy to sensitive health information. To comply with regulatory requirements, healthcare organizations need to have systems in place to monitor Business Associate (BA) compliance, and also perform regular sanctions and exclusion checks on all providers and contractors working with their organization.
A 2018 report found that internal threats accounted for 56% of all data breaches in healthcare. Healthcare organizations must implement a solid risk and compliance program to include regular training of staff on their responsibilities to meeting HIPAA, patient privacy rights, and other compliance requirements. These activities must be tracked, monitored, and have audit trails to prove that the healthcare organization has conducted this training and sanction checking.
With all these areas of compliance to attend to, and the increasing threats of cyber-attacks coupled with regulatory oversight, healthcare organizations need a solid and well-thought-out process to address compliance. A comprehensive ERM is essential and includes the identification of key parties who will be responsible for addressing each of the different areas. Full buy-in is critical from all members of the organization to make any compliance program successful.
With all the requirements and threats facing the healthcare industry, it can seem overwhelming for an organization to establish a consistent, effective, and easy enterprise compliance and risk process. Below, we provide you with 6 steps to follow to help you implement a simple and nimble healthcare compliance and data security risk program.
Determine the key individuals who will lead the risk and compliance team including someone responsible for each area of risk such as third-party vendors, employee compliance, and internal IT assets. Use the “Seven Elements” to identify high-level concerns such as:
Carefully evaluate the technical and resource competencies that exist within the organization to best determine what types of systems to implement. A web-enabled solution with faster and easier implementation timelines may be ideal for an organization with limited IT resources. It may also be advisable to choose a solution that can proactively and regularly check employees and vendors for exclusions and sanctions to reduce the administrative and resource burden on the organization.
Next, evaluate the cost of various solutions on the market that can competently address the issues identified based on your organizational needs, timelines, and budgetary constraints. Some solutions may require more internal IT support than others so be sure to consider your available IT resources before choosing a solution. Other factors to consider include:
Be sure to choose a solution that provides insight into how to resolve and remediate areas of risk and non-compliance identified, and the cost of doing so.
A baseline assessment of the risk profile of the organization should be conducted once the availability of internal resources and tools has been determined. Included in the baseline assessment should be an initial compliance audit of important frameworks such as HIPAA and MACRA, and a security review of the assets in the organization. Use the results to create a prioritized list for compliance and security vulnerabilities.
The prioritized list of compliance and security vulnerabilities created from the baseline assessment should be used to determine which areas to address first. In the risk analysis and prioritization process, ask questions such as:
It may be necessary to hire consultants to address specific areas if the resources are not available internally to do this in a timely manner.
The compliance and security management process should include regular assessments for new vulnerabilities and allow for easily resetting resources and budgets for areas of concern. A solid ERM program must have the ability to conduct regular checks, remediate, and re-check.
Some cost factors to be considered when making plans to implement a comprehensive compliance and risk management program include:
In the US, the average cost of a breach is $7.91 million with the average cost of penalties for a HIPAA violation being over $1.5 million per violation.
The cost of a damaged reputation can be significant in the highly competitive healthcare marketplace where consumers can easily choose to avoid an organization that they believe may expose their healthcare data to breaches.
Ensure solutions purchased as part of an overall ERM program provide maximum return on investment and are easy to integrate and quick to implement to avoid having to expend more in human resources for integration, and so that implementation can occur before your systems become exposed to additional threats.
Implementing a sustainable, repeatable, and effective continuous healthcare compliance and risk management process is critical for healthcare stakeholders and organizations. Being able to bring all distributed compliance activities together consistently allows the key management team to understand areas of vulnerability, prioritize risk, and focus on the highest-impact remediation activities. Strong healthcare technology solutions can assist in reducing the overall cost of compliance and risk management processes and assure regular and adaptable action to new compliance threats.