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Managing the Regulatory Environment: Why It Matters

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Managing the Regulatory Environment | Introduction
What it Means and Why It Matters
 man trapped in a maze

Adherence to current regulations and guidelines is one of the most challenging aspects of running a dental practice, especially since it requires dealing with so many different agencies. Being knowledgeable about current regulations and working towards compliance are critical steps for practices to achieve both a safe dental office and peace of mind.

The regulations imposed upon the healthcare industry are intended to make every treatment environment a safe one. By following regulations, you and all other healthcare workers demonstrate and reaffirm your commitment to providing patients, team members and the broader community with a safe environment. The American Dental Association’s (ADA) Principles of Ethics and Code of Professional Conduct addresses regulatory compliance in its discussions of ensuring that every dentist practices in an ethical manner and in accordance with the standards of practice to date. Another benefit to following the regulations is that doing so may minimize your potential liability from any adverse outcomes.

Following all applicable regulations and guidelines in your dental practice can also protect your dental practice as a business. Today’s dental patients expect certain precautions to be in place and, while they may not comment about it, they notice when a practice consistently follows protocols designed to protect everyone. They also notice when a dental office doesn’t comply, especially since those types of violations typically receive a great deal of publicity. While a patient might not comment about any perceived oversights personally to you or someone on your staff, they may opt to seek care elsewhere just as a precaution. Or they may opt to file a report that alleges the failure to follow certain protocols with the appropriate regulatory agency.

Keep in mind that regulations can and do change and that you have a legal and ethical responsibility to remain aware of any changes. Also remember that state and local regulations may differ from those issued by federal agencies and can also change. It’s up to you to be aware of all regulations at each level that may apply to your practice. In cases where there might be differences between federal, state and local regulations, it’s always a good rule of thumb to adhere to the most stringent requirements.

Because regulations change, regulatory compliance requires that you educate and train the members of your team regularly and that you demonstrate that all compliance activities and protocols have been consistently monitored and logged. Make sure that any staff training or compliance support is conducted by someone who is knowledgeable and credible about the topic. In certain situations, it may also be helpful to seek legal advice from a qualified attorney.

While some practices assign a team member the responsibility for ensuring compliance, remember that you, as the leader of the team and owner of the practice, are ultimately responsible. Safeguard your practice and yourself by carefully documenting all practice activities that relate to regulatory compliance. Failure to provide documentation during an audit could put the practice at risk.

Finally, following regulations is the right thing to do, for everyone.

The content contained in the Managing the Regulatory Environment module of the American Dental Association’s Guidelines for Practice SuccessTM (GPSTM) provides general information about regulations issued by several federal agencies that are charged with ensuring that dental treatment is provided in a safe facility, that dental healthcare workers work in safe environments, and that the dental practice is managed and operated in a way that is not harmful to others or the environment. The module also includes original resources, such as checklists and tip sheets that were created specifically for this project and designed to help ADA members comply with the appropriate federal regulations.

As this resource was finalized in the first part of 2017, the new presidential administration had indicated it would seek to aggressively revise the regulatory landscape. Thus, while we believe that this snapshot will be useful to dentists, you should continue to pay attention as laws, rules, regulations and enforcement priorities shift. 

The Centers for Disease Control and Prevention (CDC)

The Center for Medicare & Medicaid Services (CMS)

The Drug Enforcement Agency (DEA)

The Environmental Protection Agency (EPA)

The Occupational Safety and Health Administration (OSHA)

The Office of Civil Rights (OCR)

The American Dental Association thanks the following individuals for their contributions to this module:

  • Dr. Andrew B. Brown, Council on Dental Practice 2012-2016, chair 2015-2016
  • Dr. Terry O’Toole, Council on Dental Practice 2013-2017, chair 2016-2017
  • Dr. Craig Ratner, Council on Dental Practice 2014-2018, vice chair 2016-2017
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  • Dr. Jean L. Creasey, Council on Dental Practice 2012-2016
  • Dr. Stacey Van Scoyoc, Council on Dental Practice 2015-2019
  • Ms. Leslie Canham
  • Ms. Teresa Duncan, MS
  • Ms. Kathy Eklund
  • Ms. Linda Harvey
  • Dr. Howard Pactovis
  • Mr. Duane Tinker
  • Ms. Olivia Wann, JD

In addition to the individuals cited above, principal contributors to this publication include Dr. Pamela M. Porembski, director, Council on Dental Practice, Cynthia Kluck-Nygren, manager, Dental Team Activities and Publications, and Dr. Diane Metrick, senior manager, Special Projects and Emerging Issues. Special thanks to the ADA’s Council on Dental Practice and Council on Ethics, Bylaws, and Judicial Affairs for their review of and contributions to this module.


The American Dental Association created the Guidelines for Practice Success™ (GPS™) on Managing the Regulatory Environment as a resource to help dentists be aware of – and comply with – some of the many federal regulations that relate to providing dental treatment in an environment that is safe for both dental patients and dental healthcare workers. In making these materials available, the ADA does not, nor does it intend to, provide either legal or professional advice. None of the content in this module represents ADA’s legal or professional advice as to any particular situation you might face or any decisions you may need to make regarding patient and/or staff safety. Guidance of that nature is most appropriately provided by a properly qualified professional, such as an attorney and/or consultant who specializes in regulatory compliance, in your jurisdiction.

While some content within the ADA’s Guidelines for Practice Success™ (GPS™) on Managing the Regulatory Environment may discuss certain federal and state laws in very general terms, it does not and cannot address every federal and state law, rule or regulation that could affect in-office protocols, procedures, and activities relating to complying with federal regulatory statutes. Each dental practice must be aware of and comply with applicable state and federal laws, rules and regulations. This resource refers to various federal statutes and regulations, including those adopted by agencies such as the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), the Drug Enforcement Agency (DEA), and others. None of the information in this module has been reviewed or approved by representatives of those or any other federal agencies. The structure and design of each practice’s regulatory compliance plans, activities, training, and other programs will be unique to that practice and each practice should appropriately consider, and abide by, the federal, state and local stipulations regarding them.

We have made every effort to make these materials useful and informative. As a consumer of this information, however, you must understand that laws vary between jurisdictions and that changes to those rulings may occur more frequently than this resource is updated. For that reason, we make no representations or warranties of any kind about the completeness, accuracy, or any other quality of these materials or any updates, and expressly disclaim all warranties, including without limitation all implied warranties (including any warranty as to merchantability and fitness for a particular use).

To the extent that we have included links to any websites, we intend no endorsement of their content and imply no affiliation with the organizations that provide their content. Nor do we make any representations or warranties about the information provided on those sites, which we do not control in any way.

We welcome your comments and suggestions regarding the ADA’s Guidelines for Practice Success™ (GPS™) on Managing the Regulatory Environment.