Are we talking about bureaucratic red tape? Sorry, no. We’re talking about a necessary reality for US healthcare operations. Yes, even marketing! 

If you’re in the business of healthcare practice, you’ve bumped into HIPAA by now. And if you find it confusing, that’s completely normal. HIPAA is notorious for being vague. As a result, full HIPAA compliance is bound to feel elusive at least some of the time. 

And so, we’ve compiled a straightforward guide to HIPAA and its many requirements. Here, we’ll cover what the law entails, what it means to be HIPAA compliant, and the potential consequences if your practice falls short.

What is HIPAA? What does it mean to be HIPAA compliant? 

“HIPAA” stands for the Health Insurance Portability and Accountability Act. 

Essentially, HIPAA is a set of rules enforced to safeguard an individual’s medical information.  It covers health plans, healthcare providers, and clearing houses that use electronic tools and platforms for transactions.  

The rule ensures that a patient’s private health details are protected and controls how they’re used or shared without their consent. Plus, the patients have some rights too, like getting copies of healthcare records or asking for fixes if something’s not right. 

On the books since 1996, the law—and its accompanying amendments—helped develop a system of national standards to fortify personal healthcare information (usually referred to as “protected health information” or “PHI”) against unauthorized disclosure. 

You might be wondering what PHI covers. A few examples of it are: 

  1. Personal Identifying Information: Names, addresses, birthdates, Social Security numbers, and other similar information that can be used to identify an individual. 
  2. Health Information: Medical records, diagnoses, treatment plans, prescription information, test results, and other health-related data. 
  3. Payment Information: Billing records, insurance information, and any other data related to the payment for healthcare services. 

HIPAA’s ultimate aim is to improve “the efficiency and effectiveness” of the US healthcare system. 

HIPAA enforcement is in the hands of the US Department of Health and Human Services (HHS).  

The individuals and organizations subject to HIPAA rules include: 

  1. Healthcare providers:  
    Any healthcare provider who electronically transmits health information, regardless of their size. These transactions include: 
  • Claims 
  • Benefit eligibility inquiries 
  • Referral authorization requests 
  • Or any other transactions specified under the HIPAA Transactions Rule 
  1. Health insurance companies 
  1. Healthcare-related businesses and organizations: Businesses, like medical software companies, who need to access medical records to perform services for a covered entity need to be HIPAA compliant. These services include: 
  • Insurance claim processing 
  • Billing 
  • Data analysis 
  • Health plans 

These organizations, known as “covered entities,” are all obligated to meet federal regulations for HIPAA compliance. 

5 Rules of HIPAA compliance for healthcare organizations 

If we dig deeper, we find HIPAA can be broken down into five “rules”: 

1. Privacy

The Privacy Rule looks to establish a balance between the necessary flow of PHI among covered entities and an individual’s general right to privacy. The rule standardizes the usage and disclosure of PHI and requires specific safeguards for patient data, all subject to HHS oversight. 

The rule also empowers individuals to “understand and control” the methods used to view or share their PHI. (It even demands patient authorization for certain types of disclosure.) 

Permitted Uses and Disclosures 

The law says that you can use and share PHI, but you don’t have to. You need patient’s permission to share their information in the following cases: 

  1. Sharing with patient: If they need to see or know about their own information, you have to show it to them. 
  2. Treatment, payment, and health operations: You can use the information for things like treating that particular patient, getting paid, and running your operations. 
  3. Asking for patient’s opinion: You can ask the patient if it’s okay to share their information to know their opinion on a certain healthcare option 
  4. Sharing a bit of information: You can give out limited details for research, public health, or their own operations. 

But, in certain cases where it’s good for the public, you can use and share patient’s information without asking them. There are 9 such cases:  

  1. When you have to by law: Some instances such as government investigations or international transfers require healthcare information to be shared.  
  2. For public health: if it’s about keeping people healthy, you can share. Example: research for the development of new treatments. 
  3. Helping abuse or neglect victims: healthcare information is shared to protect people who are being hurt. 
  4. Legal situations: certain court cases require health information, such as DNA samples, that you’re obliged to share. 
  5. Dealing with the dead: you can use information about people who have passed away for certain reasons. 
  6. Donating organs, eyes, or tissue: the information can be shared if the patient or their family wants to donate after you die. 
  7. Research, in special cases: sometimes you can use patient’s info for research if it’s done the right way by qualified medical/research institutes.  
  8. Stopping danger to health: if there’s a big health threat, you can share info to prevent it. 
  9. Important government jobs: certain healthcare information may be essential for government procedures like enrolling for the army. 

2. Security 

The Security Rule extends the terms and protections of the Privacy Rule to include all PHI available in electronic format (ePHI). This rule details precautionary physical, technical, and administrative measures to prevent an ePHI breach. It’s also the point at which standards and practices for data encryption, confidentiality, and risk analysis come firmly into play. 

To comply with the HIPAA Security Rule, all covered entities must: 

  1. Ensure the confidentiality, integrity, and availability of all e-PHI. 
  2. Identify and defend against potential security threats that affect  information’s safety.  
  3. Guard against possible unauthorized uses or disclosures.  
  4. Certify compliance by their workforce. 

3. Breach notification 

The Breach Notification Rule, as the name implies, requires covered entities to report any PHI/ePHI breach to both patients and the HHS. These notifications should be made as swiftly as possible and cover the “who/what/how” of each disclosure incident, as well as any steps being taken to address fallout damage.  

4. Enforcement 

This rule finalizes the penalties and  investigation surrounding violations of HIPAA provisions for Administrative Simplification (which optimize the flow of PHI). 

5. Omnibus 

The Omnibus Rule is a catch-all amendment that marries HIPAA to the Health Information Technology for Economic and Clinical Health Act (HITECH), enacting measures for further protection of PHI. Registered in 2013, the Omnibus Rule also placed additional restrictions on the use of PHI and ePHI for marketing strategies.  

What does HIPAA compliance mean for healthcare providers? 

Healthcare providers fall directly under the auspices of HIPAA compliance. This means your practice is legally bound to comply with all five HIPAA rules, as well as each rule’s subsequent components. 

It also means your practice needs to implement ongoing processes for HIPAA risk assessment through regular security audits to identify  gaps in security coverage (while highlighting plans to fill them in as needed). 

Similarly, your practice is obliged to ensure all personnel takes appropriate steps to maintain the integrity and confidentiality of patient/prospect PHI across all technical, physical, and administrative systems. As such, HIPAA dictates that each entity must appoint a designated compliance officer to train organizational staff and oversee company-wide procedures for toeing HIPAA lines. 

“Okay…but why?” you ask. 

Well, outside the fact each patient in the US is legally entitled to a certain level of privacy, there’s an awful lot at stake for your business. 

Failure to meet HIPAA demands—even in cases where there’s no verifiable breach—can have debilitating consequences, including federal investigation, class action lawsuits, hefty personal fines, and even jail time.  

HIPAA Journal suggests violations can cost your company around $200 per victim, with state-level fines running up to $25,000 per incident category and fines for intent to sell/utilize information for personal gain amounting to up to $250,000. 

And that’s just inside your own organization. 

Your clinic is also on the hook for HIPAA-compliant operations concerning every single tool you employ—from point-of-sale software to patient/customer relationship management platforms (CRMs) and email servers–—as well as every third-party entity that provides you with added assistance. 

To avoid devastating penalties, it’s imperative you establish a business associate agreement (BAA) with each third-party vendor that handles your PHI/ePHI. These agreements should come with two fundamental guarantees: 

  1. Protection (i.e, data encryption) against unlawful disclosure of your PHI. 
  2. A plan for regularly scheduled system audits (to help reinforce security measures). 

Now, the one team that is constantly sharing information about your organization or others with patients and the world, is your marketing team. Let’s understand what HIPAA compliance means for them. 

What is HIPAA compliance for marketers? 

When HIPAA’s fifth and final Omnibus Rule made its way into the federal registry, marketers encountered newer, stronger limitations regarding PHI and other personal identifiers for patients and prospects. 

Most notably, healthcare marketers were suddenly required to: 

“…obtain a valid authorization from individuals before using protected health information to market a product or service…” 

To which most marketers might be inclined to say: Now what?” 

This stipulation obviously puts a strain on most typical marketing programs, particularly those focused on inbound strategy. 

So, game over? Pack up your marketing plans and go home? 
Not quite. 

Instead, the Omnibus Rule only demands a few tweaks to normal inbound efforts. Many lead-nurturing strategies keep well within the bounds of HIPAA compliance; you just have to proceed with caution. 

Consider these examples:  

You CAN… 

Reach out to previous patients with information that applies to their ongoing care or a value your practice offers as part of your overall services. 

But you CANNOT… 

Serve up personal data regarding patient demographics, health histories, or any other health-related identifiers to a third party. This can be for the purpose of selling a product/service, raising money for an organization, or conducting research without prior written authorization from the patient in question. The authorizations must also be upfront about any compensation they’ve received for sharing patient information. 

Put in more practical terms: 

Sending a patient an encrypted email with follow-up treatment plans alerting them of newly available practice services? Congrats: You’re good to go. 

Sending a patient an email pitch about a new pharmaceutical drug not offered as part of their ongoing care? Nope. That’s illegal.  

Thankfully, HIPAA rules allow most typical inbound activities to continue unabated. But be careful—especially when it comes to personal health information of the electronic or analog kind. 

HIPAA allows most typical inbound activities to continue unabated––but be careful. 

“Careful” should translate to codified systems for safeguarding all patient data and for regular reviews of all PHI activity. Plus, as mentioned above, you should have a BAA in place for any third-party service you deploy, particularly any email providers or web hosting services you use to collect, transfer, or store patient information at various points in the sales funnel.  

Helpful resources: 

HIPAA compliant texting guide 

HIPAA compliant email marketing guide 

So, let’s talk about what happens when someone doesn’t play by the HIPAA rules. Breaking the rules comes with some hefty penalties. 

HIPAA compliance violations 

 There are four tiers of violations that can get you in trouble: 

  1. Unintentional Oops: You didn’t mean to spill the beans, but if your organization didn’t know better and still let your PHI leak, you might face fines from $100 to $50,000 per incident. 
  2. Reasonable Ignorance: You knew the rules, but you didn’t really pay attention. That’s not gonna fly, and you could still get fined from $1,000 to $50,000 per incident. 
  3. Willful Neglect – Corrected: You goofed up, but you managed to fix it ASAP. You’re still looking at fines ranging from $10,000 to $50,000 per incident. 
  4. Willful Neglect – Not Corrected: You made a mistake and didn’t do anything to correct it right. This one will cost you big time, with fines from $50,000 to $1.5 million per incident. 

You can fall into one of the categories mentioned above because of the following reasons: 

  1. Snooping Without Permission: Imagine someone peeking at your medical secrets without your say-so. That’s unauthorized access or disclosure. Basically, it’s when someone gets their hands on your protected health info (PHI) without the proper thumbs-up. 
  2. Late to the Breach Party: If a PHI breach happens, and nobody bothers to tell the affected folks or the authorities in time, that’s a breach notification failure. It’s like not sending out an SOS when there’s a leak in the PHI ship. 
  3. Slacking on Security: You know how you lock your front door to keep your home safe? Well, not putting in the right locks and alarms for your PHI is a no-no. This is called a lack of safeguards – not keeping the physical, technical, and administrative resources in place to shield your PHI from prying eyes. 
  4. Unprepared Team: Imagine a basketball team not knowing the rules of the game. Similarly, if a group of employees doesn’t know how to handle PHI according to HIPAA, it’s a foul. Poor training means they might slip up, leading to violations because of carelessness or oops moments. 

So, these are like the common slip-ups that can get an organization or even an individual in trouble with the HIPAA rulebook. It’s like a reminder to play it safe and keep everyone’s health secrets, well, secret! 

Still feeling HIPAA helpless? 

If any of the above seems too complicated or you’re at a loss for how to get started on compliance, a HIPAA-compliant CRM might just be your new best friend. 

With a customer relationship management platform designed for HIPAA compliance, much of your due diligence work is done for you. An end-to-end solution such as LeadSquared, can assist in creating a secure, single-source overview for patient profiles, health histories, appointment schedules, and more. 

It can also help facilitate: 

  1. Lead capture and management, allowing you to safely house, search, and share information on potential patients with members of your team. 
  2. Marketing automation, enabling compliant outreach through automated communications with existing/prospective clients. 
  3. Engagement scoring, providing the tools to trace engagement behavior and help nurture ongoing customer relationships.  

And with compliant solutions like LeadSquared, a HIPAA BAA always comes standard. (No need to worry about ticking an endless number of legal boxes before launching your next campaign.) 

The takeaway… 

HIPAA, like all legal provisions, can be a complex animal. 

To achieve HIPAA compliance in marketing, you’ll have to watch your step when it comes to the content of your message and the trafficking of patient data. 

If you’re just learning the HIPAA ropes, a HIPAA-compliant CRM is an exceptionally good place to begin your practice- and department-wide compliance plan. Get in touch with our team to know more!  


1. Why do healthcare organizations need HIPAA compliance? 

HIPAA compliance is necessary to protect patients’ private health information and maintain trust. Following the HIPAA rules helps you avoid legal penalties for mishandling sensitive data. 

2. Along with HIPAA compliance, which laws should healthcare businesses in India abide by?

Besides HIPAA, Indian healthcare organizations need to comply with the  “Digital Information Security in Healthcare Act (DISHA)”. It is designed to ensure privacy, security, confidentiality, and standardization of healthcare data. 

3. Who controls and regulates HIPAA guidelines? 

In 1996, the Health Insurance Portability and Accountability Act (HIPAA) mandated the U.S. Department of Health and Human Services (HHS) Secretary to create rules safeguarding the privacy and security of specific health information. 


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