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The HIPAA Journal is the leading provider of HIPAA training, news, regulatory updates, and independent compliance advice.

What is a Healthcare Compliance Program?

A healthcare compliance program is a process of implementing policies and procedures that have been developed to support compliance with federal, state, local, and industry regulations and voluntary standards in the healthcare industry. Because organizations have different compliance obligations, there is no one-size-fits-all healthcare compliance program. However, most compliance programs have the same seven elements:

1. Implement policies, procedures, and standards of conduct.

Because healthcare organizations’ compliance activities do not start from scratch (because some privacy or security measures already exist), most compliance programs begin with a healthcare compliance plan. The plan is developed by listing which regulations and standards are applicable to an organization’s activities, assessing the effectiveness of existing compliance measures, and developing a plan to fill the gaps in compliance and other threats or vulnerabilities.

2. Designate a compliance officer and/or compliance team.

Several regulations (i.e., HIPAA) require healthcare organizations to designate a privacy and/or security official who has the responsibility for delivering the healthcare compliance program. Ideally, the compliance officer(s) should be supported by members of a compliance team with experience in the challenges of compliance in a healthcare environment. For example, a frontline worker, rather than a clerical worker who has no or little day to day contact with members of the public.

3. Provide training to all members of the workforce.

Healthcare compliance training is often divided between privacy training for those for whom it is applicable and security awareness training for all members of the workforce. It can be a mistake to approach compliance training this way because members of the workforce for whom privacy training is not applicable may disclose patient information without knowing it is a compliance violation. It is important that all members of the workforce receive training on privacy and security compliance.

4. Develop effective lines of communication.

Effective lines of communication are essential to a healthcare compliance program so members of the workforce can be advised of policy changes, and so members of compliance teams can be alerted to potential compliance violations. Some regulations require communications (i.e., the Patient Safety Rule/42 CFR Part 3), and organizations to whom these regulations apply with be in violation of the regulations if their healthcare compliance program does not include lines of communication.

5. Conduct internal monitoring and auditing.

It was mentioned in the introduction that a healthcare compliance program supports compliance with regulations and standards. It is important to be aware that having a healthcare compliance program does not guarantee compliance. Compliance is a multifaceted activity that requires internal monitoring and auditing to ensure that people, processes, and technology are contributing to the organization’s compliance activities in the way intended.

6. Enforce policies and procedures through sanctions.

The enforcement of policies and procedures through sanctions must be done fairly and equally. A healthcare compliance program will not be effective if (for example) one team leader applies sanctions for every policy violation while another team leader turns a blind eye to compliance to allow team members to “get the job done”. In some cases, it may also be necessary to monitor the frequency and severity of sanctions applied by each team.

7. Respond promptly and undertake corrective action.

This element of a healthcare compliance plan is often interpreted as responding promptly to compliance violations or data breaches. However, it can be equally applicable to responding promptly to policies and procedures that are not working and revising them to make them effective. Most regulations and standards require “periodic” reviews of policies and procedures, whereas it is a best practice to monitor their effectiveness on an ongoing basis and reassess as necessary.

The Benefits of a Healthcare Compliance Program

The benefits of a healthcare compliance program are that the program helps healthcare organizations avoid legal risks and penalties for non-compliance, protects the privacy and security of individually identifiable health information, and improves the quality and safety of patient care. A healthcare compliance program can also promote a culture of ethics.

However, there is no one-size-fits-all healthcare compliance program. Each compliance program should be tailored to fit the unique needs and circumstances of each healthcare organization. This should be done by first developing a healthcare compliance plan and implementing the plan with the assistance of customizable healthcare compliance software.

To find out more about healthcare compliance programs and the best ways to ensure they are effective, you should speak with a professional compliance advisor.

Author: Steve Alder is the editor-in-chief of The HIPAA Journal. Steve is responsible for editorial policy regarding the topics covered in The HIPAA Journal. He is a specialist on healthcare industry legal and regulatory affairs, and has 10 years of experience writing about HIPAA and other related legal topics. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics. Steve shapes the editorial policy of The HIPAA Journal, ensuring its comprehensive coverage of critical topics. Steve Alder is considered an authority in the healthcare industry on HIPAA. The HIPAA Journal has evolved into the leading independent authority on HIPAA under Steve’s editorial leadership. Steve manages a team of writers and is responsible for the factual and legal accuracy of all content published on The HIPAA Journal. Steve holds a Bachelor’s of Science degree from the University of Liverpool. You can connect with Steve via LinkedIn or email via stevealder(at)hipaajournal.com

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