Fine data trends can paint a partial picture of how the HIPAA compliance landscape is evolving. Last year, the HHS assessed $17.09 million in fines, a 156% increase over the $6.19 million assessed two years prior. Enforcement is trending toward more severe penalties, especially in cases of "willful neglect" where fines can reach up to $50,000 per incident.
HIPAA’s strict requirements for electronic personal health (ePHI) and document management have contributed to a unique climate of risk in the industry. Healthcare is the only industry where employee error is more likely to cause an information security incident with data loss than external hackers.
Adopting compliant processes for data and document management can enable your healthcare organization to avoid the risks of HIPAA non-compliance and human mistakes. In this post, you’ll learn the steps to setting up compliant management processes and how to reduce your regulatory risk.
Document Management Processes and HIPAA: What You Need to Know
Who needs a HIPAA-compliant document management process?
The answer could surprise you. Hospitals, clinics, and other healthcare delivery organizations are required to comply with HIPAA. However, manufacturers in pharma, life sciences, and medical device fields may also be impacted by HIPAA if they are doing complaint handling and investigations (CAPA). Contract manufacturers may not be affected, because their role in the CAPA process is limited to providing information specifically related to their product for inclusion in the sponsor's complaint file.
Generally, Class 3 medical devices are required to comply with HIPAA because they are high-risk implantable or life-sustaining devices, and any issues encountered by end users would need to include ePHI to describe the complaint. Chances are, any organization conducting clinical trails would likely be impacted by HIPAA as well, although general consent to participate in a clinical trial is covered by the FDA 21 CFR part 50.
Organizations who provide direct care to patients aren’t the only ones who need to consider whether their processes for document management comply with HIPAA. If your company handles patient complaints, manufactures Class 3 medical devices, or is conducting clinical trials, you may also need a HIPAA-complaint process. Legal counsel is generally the best path to determining your specific regulatory requirements and risks.
9 Steps to Implement an Effective Document Management Process
Document management processes enabled by QMS software allows HIPAA-impacted organizations in healthcare, pharma, and life sciences to reduce regulatory risk. It's important to understand that document management is only one part of HIPAA compliance, and a process is unlikely to meet all of the procedures and practices your organization needs to protect ePHI.
HIPAA offers a checklist for evaluating document management solutions against requirements, which includes:
- Unique user identification
- Automatic logoff
- Encryption and decryption
- Data backup and storage
- Facility security planning
- Login monitoring
- Access authorization
Your document management software needs to meet all of these requirements for data protection to comply with HIPAA. However, a process is necessary in addition to software to ensure HIPAA compliance is operationalized.
Employees must be trained on how to use software securely because activities such as sharing passwords can take your organization out of HIPAA compliance. Technology alone isn't enough. HIPAA-compliant data handling requires disseminating knowledge and a structured approach to defining document management processes.
1. Define Scope
The first step toward understanding your HIPAA requirements for document management is to define the scope of documents and records used in operational processes. Not all of these documents will include ePHI, but a full scope assessment is critical to align software with processes and ensure total compliance. At pharma and life sciences organizations, the scope assessment is likely to reveal:
- QA documents
- Batch records
- Product specifications
- Customer complaints
Scope definition is the first step toward assessing your regulatory risk and improving HIPAA compliance. When the types of documents your organization uses and creates have been established, you can work to understand which parts of the documentation include ePHI.
2. Document Current Processes
Working from the list of the types of documents and records, create comprehensive documentation of the current storage locations, linked processes, and process owners. The goal of this step of the process is to define carefully written procedures for preparing documents, processing the records, distributing the records, and storage. This exercise is generally best accomplished through review of the standard operating procedures and existing quality management systems, along with collaboration with process owners.
As you work to understand your current document management processes, be careful to consider the role of user endpoints. Do your owners review, author, or process documents on laptops or mobile devices? Documenting endpoints is an essential part of the risk mitigation process.
3. Address Archival
HIPAA includes a clear definition of procedures for data archival, access, and obsolescence. If you are implementing new software for document management or evaluating your current quality management solution for compliance, it is critical to address data retention. HIPAA may require data retention up to 6 years, and many U.S. states have additional requirements for retaining data.
After determining the specific requirements which impact your organization, you will need to decide if archive files can be imported to the new system, or if the current storage solution meets requirements for archiving ePHI. If you continue to archive data in a separate system, it must adhere with HIPAA's guidance on access control and access tracking.
4. Configure Software
With a definition of documents, data, processes, and a plan for archived records, your organization can begin efforts to configure the system you have selected for document management or perform necessary updates to an existing system. Generally, the configuration process will involve aligning the critical features of a compliant document management system (DMS) with operating processes:
- Secure, encrypted database
- Data backup
- Automated retention procedures
- Role-based employee access
- Comprehensive audit trails
Depending on the industry your organization operates in, you may need to consider the risks of process revalidation during software configuration. If your setup involves the use of extensive customized code or other significant actions to modify software, you may need to consider FDA requirements for process validation or revalidation. Using built-in features for configuration can reduce the risks that manufacturing processes require regulatory validation.
5. Define Documents and Workflows
If you are implementing a new document management software, you will need to define the types of documents, business workflows, and other requirements during the implementation process. The precise best practices for this activity can vary depending on your software vendor. However, it is generally wise to take advantage of features for streamlined workflows and automation before going live to create efficiency and consistency in your new process.
Prior documentation efforts to define the role of process in each document can simplify this process. Examples of the activities you may take to prepare for organization-wide document management which complies with HIPAA could include:
- Using the template editor to standardize common document types
- Creating guided workflows for document drafting, review, and approval
- Creating automated notifications for document collaborators and process owners
6. Create an SOP
Compliance, quality, leadership, and process owners should collaborate to create an updated standard operating procedure (SOP) for the specific purpose of governing document management in the organization. This activity is vital to meet HIPAA requirements to document data management and archival processes as well as cGMP requirements to maintain comprehensive operating procedure documentation.
The SOP should be authored by the new HIPAA document management process owner, with participation and feedback from subject matter experts. To ensure the document reduces regulatory risk, obtain approval from HIPAA compliance experts and commit to frequent review and revision of the newly generated SOP. Include the software's role in document control and, if useful, generate checklists to educate stakeholders.
7. Import data
If your organization is adopting a new system, you will need to import documents and data into the new system before going live. Efforts to define document types and standardize workflows and access in a new system can provide the groundwork for a successful, simple document import process.
With any data import, there are risks of data corruption or accidental data exposure. The use of a defined document validation process is a necessity to limit risks, inspired by the Demming cycles featured in ISO 9001. The import process should follow a defined pattern to “plan, do, check, and act,” including extensive testing and validation of imported document security.
Related Reading: 13 Bottom Line-Boosting Benefits of a Quality Management System.
8. Train Users
56% of healthcare security incidents last year were caused by human error. The most significant compliance and security risks in the industry are related to innocent mistakes, such as employees who accidentally email protected data to the wrong person or employees who share login credentials with their colleagues. Employee education and user training is a necessity to limit human error and ensure your team is prepared to adhere with steep HIPAA requirements for data handling.
Your training program should focus on the successful use of the new system and HIPAA requirements to ensure employees are prepared to adopt the new process without any speed-bumps successfully. During training, employee feedback may uncover opportunities for process improvement or automation which can improve the security of your new system.
9. Go Live
When employees, policies, and leadership are ready, it's time to go live with your new software-guided document management for HIPAA-compliant data handling. For best results, don't treat your go-live date as the absolute end of the project.
Work closely with employees to understand how the new system impacts workflows and user satisfaction, and implement improvements in the days following your go-live date. An active, user-focused approach to implementation is necessary for organization-wide adoption and compliant processes.
Get Advice from a Pro
Any organization in the healthcare industry will affirm that HIPAA requirements for secure data handling and document management are increasingly complex. For organizations in the pharma, life sciences, or medical device industries these requirements can be even more complicated, and seem like an additional regulatory burden when coupled with FDA cGMP or EudraLex. If your organization performs clinical trials, manufactures class 3 medical devices, or handles customer complaints, you may be required to comply with HIPAA standards for document management.
Implementing a new process or system for document management is no small undertaking, particularly at pharma and life sciences organizations which may have complex workflows and hundreds of existing SOPs. If you’re overwhelmed by the idea of adopting a new system or going paperless, expert advice could be a useful tool to streamline your efforts.
Qualio is a comprehensive solution for quality management and document control and a first-of-its-kind system designed under FDA and ISO requirements for cGMP. To learn more and view a demo, click here.