New Regulation– Now What? Step-by-Step Guide to Managing Compliance Changes 

Regulations in healthcare change constantly. When a new law or regulation is enacted, compliance teams must act quickly to assess its impact, assign responsibility, and ensure implementation. With regulations often spanning hundreds of pages, how can compliance teams efficiently manage the process without missing critical details? 

It’s important for compliance professionals to identify the who, what, where, when, and how of managing new regulations – and how regulatory change management tools, resources, and software (like YouCompli) streamline this process. 

Step 1. Understand the New Regulation (The What and Where) 

Before action can be taken in response to newly enacted or newly updated regulations, compliance teams must first understand the regulation at hand.  

What does this regulation say? 

That’s right – first things first. Compliance teams must read the regulation. It’s all too common that reading the regulation entails digesting hundreds or more small-print pages from federal and states sources. It’s time-consuming, but it’s necessary as the foundation when understanding what regulations apply to your organization and how. While you may be able to determine fairly quickly that it is in fact not applicable, you must spend a significant amount of time making this determination. 

Which parts of the organization are impacted by this regulation? 

Where does this regulation apply? 

In addition to understanding the impacted services, departments, staff, etc. it is also key to know what locations are affected by the update. Hospital and healthcare systems are very often not isolated to a single state or jurisdiction. This brings with it the need to keep track of locations, and which regulation impacts certain locations, as well as the crossover for regulatory jurisdictions and unique settings or services within your organization.  

Step 2. Assign Responsibility (The Who)  

Once compliance teams are clear on requirements and work needed to comply with new regulations, you must next identify who in the organization is going to be responsible or take ownership of ensuring the work is done. 

Organizations must answer the following to manage regulatory changes: 

• Who is responsible for compliance? The compliance team often leads the process in healthcare organizations, in collaboration with legal, operations, IT, HR, finance, and clinical leadership. Identifying a person, department, or team that is ultimately responsible for compliance is key. 

• Who will implement the required changes? Compliance teams can facilitate this process by providing a clear outline of the required changes and helping the team build a plan to comply. This will often help identify the person, department, or team that makes the most sense to take ownership of implementation.  

• How will compliance monitor and facilitate this process? Compliance teams should identify within operations who is responsible for implementing regulatory changes but should also share responsibility for the success or failure of compliance activities within operations. Compliance teams are a resource, tool, collaborator, and monitor, and can provide guidance for teams tasked with compliance activities. 

Step 3. Establish a Timeline (The When) 

Not all regulations have a single effective date, and multiple regulatory changes are often managed simultaneously. Some changes require immediate action, while others allow a phased rollout over months or years. To keep your compliance and operational teams on track, it’s important to: 

• Identify the effective date of the regulation. 
• Set internal deadlines or due dates for necessary risk assessments, policy updates, and training. Don’t wait until the last minute! 
• Use a compliance calendar as part of your compliance program to reduce risk of noncompliance with federal and state laws by identified effective dates and plan your team’s work accordingly.  

Step 4. Implement, Monitor and Report (The How) 

Compliance teams must have tools and resources in place to execute the compliance plan by: 

• Managing implementation of regulatory changes and identifying updated policies, procedures, and training completed.
•  Conducting audits and tracking ongoing compliance over time (post-implementation). 
• Reporting on compliance activities, status of implementation activities, compliance achievements, improvement opportunities, and sharing best practices or addressing frequently asked questions.  

Are You Prepared for the Next New Healthcare Regulation? 

Transparently reporting on the state of your compliance program and integrating compliance activities into all levels of an organization is key to reaching objectives and maintaining ongoing compliance. Whether you’re using a regulatory change management software like YouCompli, or a manual process of spreadsheets, emails, appointments, and project management, understanding the who, what, where, when, and how of regulatory compliance will let your compliance teams and healthcare organization effectively manage regulatory changes.  

---