- How compliance with laws, rules, and regulations differ by industry
- Examples of compliance
- Developing a compliance program
- How compliance management software will help
Most executives understand that compliance is important to their organization's operations, helping to govern internal policies and rules, and ensuring that employees are following state and federal requirements, governmental regulations, standards, and ethical practices.
Compliance with laws, rules, and regulations should be an essential part of your business operations, regardless of industry.
So how does your organization manage compliance and reduce the risk of violations? How do you follow your industry's regulatory framework? Ensuring compliance from the start can save you and your organization untold costs in penalties, fines, loss of accreditation, loss of reputation, and even criminal prosecution.
This article will look at compliance for healthcare organizations, the private sector, and law enforcement, as well as how you can create a successful compliance program.
How compliance with laws, rules, and regulations differs by industry
Whether it's a healthcare system, law enforcement, or the private sector (e.g., finance, manufacturing, corporations), it's important that employees understand the rules they're supposed to follow. A policy and procedure manual will make this possible, as it sets the standards for all employees to follow, incorporating state and federal regulations, ISO standards, and accrediting agencies.
Each sector is similar in that they all have rules and policies they must follow, whether those are legal and ethical requirements, performance standards, or best practices. Violating those policies can lead to a loss of license, loss of accreditation, or even criminal prosecution.
However, there are a few key differences in each sector.
Healthcare regulations and best practices have been created by a number of different accrediting and professional associations. Even within the healthcare field, different jobs are directed by different accreditation agencies.
Plus, healthcare providers are also governed by these non-medical agencies.
- The Social Security Act regulates Medicare, Medicaid, CHIP, and more.
- HIPAA and the HITECH Act require healthcare organizations to protect patient data and protected health information.
- The Patient Protection and Affordable Care Act created new requirements for insurance, Medicaid, and more.
- The Drug Enforcement Administration and the Food and Drug Administration regulate medication creation and distribution.
- The Department of Health and Human Services and the Office of the Inspector General help protect against fraud.
The private sector usually has two areas of compliance
- Regulatory compliance: The steps needed to comply with external laws and regulations. Organizations that violate regulatory compliance may face fines, legal action, prison time for executives, or could be shut down entirely.
- Corporate compliance: The steps a corporation needs to comply with its own policies, procedures, and behavioral norms. Without this program, a company will often have wasteful practices and may engage in unethical behavior.
There are also specific regulations and policies that are required by the banking industry, which are increasing in complexity and number. (Now there are roughly 200 new updates per day, compared to 10 per day in 2004.)
The financial sector is bound by regulations like the General Data Protection Regulation (GDPR), Common Reporting Standard (CRS), data privacy regulations, cybersecurity, and other consumer laws like the Home Mortgage Disclosure Act, Truth In Lending Act, Fair Credit Billing Act, and the Fair Credit Reporting Act.
And all corporations are required by law to follow employment laws like the Family and Medical Leave Act, Fair Labor Standards Act (wages and hour laws), anti-discrimination laws, Age Discrimination in Employment Act, anti-harassment laws, and the Americas with Disabilities Act.
There are also employee health and safety regulations set by OSHA, and several regulations on labor relations, unions, and immigration laws.
Law enforcement organizations (LEOs) often have several critical policies and regulations they need to follow.
For example, there are policies and best practices set forth by the International Association of Chiefs of Police (IACP) and Commission on Accreditation for Law Enforcement Agencies (CALEA) on subjects like:
- Drone policy
- Social media policy
- Narcan policy
- Body cameras
- Policing the mentally ill
- Communicable diseases
- Active shooter response
- High-speed pursuit
- Racial profiling
- Take home vehicles
To learn more about compliance with corporate and healthcare regulations, or ensuring compliance with law enforcement regulations, you can visit our website.
Examples of compliance
Here are a few examples of compliance programs in healthcare, law enforcement, and the private sector.
What does HIPAA compliance mean?
The Health Insurance Portability and Accountability Act (HIPAA) is a national standard that spells out how patient data is protected and handled by certain organizations, following “privacy, security and administrative simplification” measures.
HIPAA compliance generally means HIPAA policies and procedures are followed in three primary areas: administrative, technical, and physical. They cover how your facility processes, uses and discloses patient protected health information.
According to the Centers for Disease Control and Prevention, to comply with the HIPAA Security Rule,
"(A)ll covered entities must do the following:
- Ensure the confidentiality, integrity, and availability of all electronic protected health information
- Detect and safeguard against anticipated threats to the security of the information
- Protect against anticipated impermissible uses or disclosures
- Certify compliance by their workforce"
FBI CJIS compliance
The FBI created the Criminal Justice Information Services Division (CJIS) in 1992 to equip law enforcement, national security, and the intelligence community with criminal justice information. The CJIS Security Policy sets security requirements for any organization that wants to access the data. Their standards include best practices for data encryption, wireless networking, remote access, multi-factor authentication, and physical security.
PowerDMS even went through our own CJIS Compliance process to ensure our data and security policies met the CJIS Security standards.
To meet the CJIS Compliance regulations, start with reviewing your current security policies and procedures, starting with your current policy manual. List out the policies that need to be aligned to CJIS standards.
Next, review your IT systems. The FBI CJIS policy has specific requirements for data encryption, data transfer, wireless networking, remote access, and mobile phones, just to name a few areas.
You also want to ensure that your data access areas and methods are very secure, so that can include your server room as well as the mobile phones used to access the data.
You can learn more about FBI CJIS Security Policy Compliance on our website.
While we're on the subject of information security, let's talk about ISO 27001, as well as the need for compliance management software for ISO 27001.
This is the international standard that provides requirements for an information security management system (ISMS). (There are actually several standards in the ISO 27000 family.)
Using the standard allows organizations to manage the security of financial information, intellectual property, employees' personally identifiable information, and information entrusted by third parties.
ISO 27001 certification is not required for any organization, although many implement it so they can benefit from the best practices. Other organizations embrace it to reassure their customers and clients that its recommendations have been followed.
A typical ISO 27001 checklist typically looks something like this, depending on the organization and source.
- Assemble an implementation team.
- Define and develop the ISMS plan.
- Initiate the ISMS and define its scope.
- Establish a security baseline.
- Establish a risk management program.
- Identify and implement a risk treatment plan.
- Measure, monitor, and review.
- Take corrective action with the ISMS.
The ISO 27001 standards are so big and complex, it would be nearly impossible for a team of people to manage the compliance process by themselves. This is where compliance management software can mean the difference between meeting those standards or failing to meet them and committing regulatory violations that could have been prevented just by following those best practices.
Of course, a lot of this looks like any policy creation process: Identify the problem, create the policy, assess it, measure the results, correct the policy as needed. You can learn more about compliance management software for ISO 27001 on our website.
ISO 9001 (DNV NIAHO)
ISO 9001 is the international standard for creating a Quality Management Systems (QMS). An organization uses a QMS when they need to demonstrate its ability to consistently provide products and services that meet customer and regulatory requirements.
The National Integrated Accreditation for Healthcare Organizations (NIAHO) is a program offered by DNV GL Healthcare USA, an accrediting agency. Hospitals and healthcare organizations that want to be a part of the Medicare program must be in compliance with the Medicare Conditions of Participation.
A healthcare system that establishes the QMS has to ensure that corrective and preventive actions it takes are implemented, measured, and monitored. That means creating a system that manages quality and patient safety including all policies and procedures related to care.
Some of the functions that ISO 9001 will measure and monitor include:
- Threats to patient safety (e.g., falls)
- Medication therapy/medication use
- Operative and invasive procedures
- Anesthesia/moderate sedation adverse events;
- Blood and blood components-adverse events/usage;
- Infection prevention and control program metrics
Power DMS publishes state, national, and international standards, including 9001 and 27001, as well as law enforcement, fire/EMS, forensics, parks & recreation, and healthcare. You can learn more about publishing ISO 9001 in your policy manual at our website.
Clery Act compliance
According to CleryCenter.org, The (Jeanne) Clery Act "requires colleges and universities to report campus crime data, support victims of violence, and publicly outline the policies and procedures they have put into place to improve campus safety."
By making this data and these reports available, campus safety officials can make students aware of the risk they face on and near campus.
To ensure Clery Act compliance, your campus safety division needs to:
- Plan ahead for security alerts, pre-writer your messages, and get them cleared with campus leadership.
- Determine how you'll collect information across departments including student housing, athletics, faculty, and human resources.
- Review your reports regularly to ensure they're compliant (this can be a problem if you only issue annual reports).
- Finally, create a Clery Act handbook that captures all the best practices, including all federal reporting guidelines.
You can learn more about Clery Act compliance on our website.
Developing a compliance program
Developing a compliance program may seem a little intimidating, but it's certainly doable. You just need to focus on the key elements and follow the steps below.
- Get internal alignment. This needs to happen before you ever start building the program: You want leadership buy-in and support right from the very start. There's no reason to build a compliance program if your own leaders can't or won't support it. Teach them about the benefits of a compliance program, as well as the reduced risk of lawsuits and penalties.
- Gather your policies into a centralized location. Take inventory of all your existing policies, procedures, and processes and put them in a single location. Reviewing all the policies together can help you find out-of-date and conflicting policies, as well as show a void where you need a new one.
- Review the policies and establish a plan. After you identify the outdated policies and determine what needs updating, establish a timeline for doing that work and start assigning the updates as tasks.
- Communicate! If you want your compliance program to succeed, you need clear, open, and consistent communication. Your employees need to understand the importance and benefit of the program. If they understand the "why," they're likely to be more on board with the upcoming changes.
- Establish compliance training. In order for your employees to understand the policies, you need to train them on how the policies work and how they apply to their day-to-day work. With an online training management software, you can save time and money using e-learning instead of relying on in-person workshops and seminars.
- Create an ongoing monitoring and review process. Your compliance program should monitor how well employees are complying. You should also schedule annual, or at least regular, policy reviews and updates. This helps you future-proof your program by ensuring the policies stay relevant and do the most good.
- Accountability. If nothing happens when an employee violates a policy, then the compliance program is useless. So build accountability into the program from the beginning and include clear disciplinary guidelines and protocols that are actively and consistently enforced.
Creating an effective compliance program may seem hard, but by following these steps, you can ensure compliance with relevant laws and regulations, as well as reduce the risk of lawsuits and fines related to violations.
While creating a compliance program can seem like a daunting task, you can get the ball rolling. By incorporating the seven key elements – and following the steps above – you can lay a solid foundation for a corporate compliance program that meets your organization’s specific needs.as well as create audit trails for accreditation facilitators, government regulators, and corporate auditors to follow.
You can learn more about developing your own compliance program on our website.
How compliance management software helps
Compliance plays a critical role for organizations in highly regulated industries, several of which we've already discussed here. Organizations can reduce the risk of lawsuits, fines, and penalties by creating an effective compliance program, complete with policies, procedures, processes, and systems to address compliance requirements.
But keeping track of all the requirements and documentation can be difficult, which is why many organizations use compliance management software.
Compliance management software can ensure compliance with relevant laws and regulations. It helps you reduce the time, stress, and cost of the administrative tasks inherent in governing and tracking regulatory requirements. It also ensures that all of your employees have been properly notified and made aware of the policies, and you can even monitor their completion of training and assessments.
As the Association of Corporate Counsel said, for every dollar an organization spends on its compliance budget, it can save an average of $1.37 on damages, settlements, and fines. In other words, it pays to use compliance management software.
Compliance management software makes actual management easier. Set deadlines for completing training sessions, and then be notified when employees have completed the training or when they're in danger of bumping up against deadlines.
The software can send frequent reminder emails until employees complete their training and/or sign off on new policy updates. It's automated, which means the software will automatically track when the training is done.
It can save time and money by letting you share training content online so people can learn at their own pace and convenience.
Plus, you can deliver your training content on a variety of devices and platforms. Since it's web-based and browser-based, anyone with a phone, tablet, or laptop and a wifi or cellular signal can view the training content.
That saves money on overtime and facilities management by not having people come into the office for the training sessions.
And if there are ever corrections or updates to the policies or training content, you can push out notifications to your employees.
Regardless of what your organization does — healthcare, law enforcement, or private sector — there are myriad policies, regulations, and laws that govern how you operate and dictate what you can and can't do.
An effective policy and procedure manual, combined with a strong compliance program, can save your organization from expensive problems. And compliance management software can help you with all of that.
If you would like to learn more about compliance management software, schedule a demo of PowerDMS today.