Don’t want to get hit with a crippling compliance lawsuit?
If you own a healthcare business you’re drowning in regulations. Fail to comply with just one and you could face millions of dollars in fines and penalties. Not to mention jail time and losing your practice altogether.
Okay, need to calm down. But here’s the deal:
Between 2024 and 2025 there were 702 healthcare data breaches that exposed over 275 MILLION patient records. Yes you read that correctly.
Add in rising regulatory enforcement from federal and state agencies, and you’ve got a situation that requires immediate attention.
Fortunately, with a little preparation and knowledge of these risk management strategies, you can protect your business and operate confidently and compliantly.
Here’s what we cover:
- The Healthcare Risk Landscape Today
- The Five Categories of Compliance Risk
- Our Top 5 Risk Management Strategies
- Creating Your Healthcare Business’ Compliance Safety Net
The Healthcare Risk Landscape Today
If you thought risk management was only about preventing fires from spreading…
Think again. Today risk management is about protecting your business from every angle.
Because every interaction with a patient, every medical record you store, and every billing code you enter has risk attached to it.
Make a mistake and you could be sued by patients, audited by the state, or investigated by federal agencies.
The regulatory environment of any healthcare business includes federal HIPAA laws, state medical practice laws, billing codes, workplace safety regulations, and much more.
Staying on top of healthcare compliance is more than a full-time job.
This is why working with Healthcare Compliance Attorneys can help you manage your business’ vulnerabilities.
Recent statistics from the Department of Health and Human Services show:
There have been almost 900 HIPAA enforcement cases since 2003, totaling nearly $145 MILLION in penalties. And we’re just looking at HIPAA violations.
Violations of state compliance laws result in many more settlements.
Add it all up…
The risk to your healthcare business just isn’t going away.
The Five Categories of Compliance Risk
To manage risk, you first need to identify where risk comes from.
For healthcare businesses, that means understanding the different categories of compliance risk.
See, if you’re not compliant with one regulation, your entire business is at risk.
Don’t believe me? Here are the core compliance risk categories your business faces:
- HIPAA compliance risk
- Billing and coding risk
- Licensure risk
- Employment risk
- Patient safety risk
These categories contain numerous regulations issued by federal and state agencies. And again, if you fail to comply with just one…
Game over.
Everything from patient records to contractor agreements should be reviewed for compliance.
Our Top 5 Risk Management Strategies
Phew. With all that considered let’s move on to the good stuff.
The following are five risk management strategies recommended by healthcare regulatory compliance lawyers.
Strategy #1: Conduct Regular Compliance Audits
You can’t fix what you don’t know is broken.
The only way to understand where your compliance weaknesses are is to conduct regular compliance audits.
These reviews force you to look internally and evaluate how your business complies with regulations.
From reviewing patient documentation to testing security systems to monitoring employee compliance with company policies.
Most healthcare businesses complete compliance audits every quarter. Some industries even require monthly audits.
If your team is overwhelmed, you can even hire third-party firms to conduct independent reviews.
Strategy #2: Implement Good Documentation Practices
Documentation can be your biggest defense against lawsuits and audits.
Federal and state investigators want to see evidence that you did everything right.
But if you don’t document your compliance efforts properly, it doesn’t matter if you did everything perfectly.
Some examples of good documentation are:
- Maintaining accurate and thorough patient records
- Training records that show staff completed compliance training
- Security incident documentation
- Signed policy acknowledgements from employees
- Audit trails that highlight billing and coding decisions
Having good documentation means everything is organized and easy to find. Cloud storage can help with this (but make sure it’s HIPAA compliant).
Strategy #3: Train Your Staff
Your staff can be your greatest strength or your biggest weakness.
One employee can ruin thousands of patient records by clicking a phishing link. One wrong billing code entered by your staff can land you in a federal investigation.
That’s why it’s critical to train your staff on healthcare compliance best practices. And not just once.
Regulations, billing codes, and data security threats are constantly evolving.
Your employees should be too. Make sure your training programs include:
- HIPAA rules and security awareness
- Proper billing and coding procedures
- Patient privacy guidelines
- Updates on regulatory changes
Don’t just make them sit through a PowerPoint presentation. Training should be interactive and relevant to their job.
Strategy #4: Create Incident Response Plans
When it comes to incidents like data breaches and patient complaints, time is of the essence.
There are specific timeframes you have to notify patients of a breach. Patient complaints should be addressed ASAP.
You don’t have time to figure out what to do in these situations. Incident response plans allow you to act quickly and effectively.
Your plan should outline who does what in the event of an incident. Make sure everyone knows their role and has contact information for other key players.
You should also practice your response plan as if an actual incident occurred.
Strategy #5: Work With Healthcare Regulatory Lawyers
…and speaking of key players.
This is why it’s important to work with qualified healthcare lawyers.
I know we don’t finish our strategies with the easiest ones. But hear us out.
The healthcare industry is fraught with regulations from the federal, state, and professional levels.
Understanding how those regulations apply to your specific business can be difficult.
Healthcare lawyers can help you identify risks you may not have known about. They can help train your staff. And they’ll always have your back if you run into trouble.
Partner with a law firm now before you need them. Establishing that relationship early on can benefit your business later.
Creating Your Healthcare Business’ Compliance Safety Net
Having a sound risk management strategy doesn’t mean your business is risk-free.
In fact, it’s impossible to operate your healthcare business without any risk.
But these strategies can help you minimize risk and prepare for when things do go wrong.
A good safety net includes:
- Conducting regular compliance audits
- Updating policies and procedures
- Training staff on compliance matters
- Keeping strong documentation
- Having qualified healthcare lawyers on speed dial
- Purchasing insurance to cover remaining risk
There’s no doubt about it. Implementing these strategies will take time and money.
Failing to implement them could cost you everything.
Bottom Line
Risk management is no longer the nice thing you do to run your healthcare business.
With government agencies coming down harder than ever on businesses that make compliance mistakes, running your business means managing risk.
Understanding the areas of risk your business faces and having strategies in place to prevent and mitigate those risks should be part of every healthcare owner’s playbook.
We’ve given you an overview of the current risk landscape. And a handful of strategies that can make a real difference for your business.
Remember: Regular audits allow you to discover issues before regulators do. Good documentation can save your business during investigations. Training staff helps prevent breaches and violations. Response plans allow you to react immediately to incidents. And healthcare lawyers can help you navigate the complexities of healthcare law.
