If you’re a leader at a HealthTech company and need to understand how HIPAA applies to HealthTech — as well as how you can reach compliance — then you’ve come to the right place.
In this post, we’ll take you through a quick overview of HIPAA then dive into exactly how it applies to the HealthTech space, and finally provide you with a strategic HealthTech HIPAA compliance checklist to get you headed in the right direction. Let’s get to it!
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, is a federal US law that regulates the protection of health information by mandating that any company that deals with protected health information — or PHI — follows certain security and privacy standards, such as conducting risk analyses, implementing safeguards, and signing business associate agreements — but more on that later.
This means that any HealthTech company that handles PHI either directly or indirectly — for example, on behalf of healthcare providers or health plans — are subject to HIPAA compliance. And HIPAA compliance matters for HealthTech companies because not only does it help you safeguard your customers’ privacy and trust, it can also help you avoid costly fines and lawsuits — all while staying competitive in the market.
The challenge is that achieving and maintaining HIPAA compliance is becoming increasingly challenging given the rapid development and adoption of new technologies in healthcare — especially the tech that involves the collection, storage, and transmission of PHI.
Given that many HealthTech companies manage PHI, it’s important to first and foremost understand exactly how HIPAA defines it.
Protected Health Information is any health information that can be linked to a specific person and is about that individual’s past, present, or future physical or mental health or condition, the provision of health care to the individual, or the past, present, or future payment for the provision of healthcare. PHI includes 18 identifiers that can be used to identify the individual, such as name, phone number, email address, physical address, social security number, medical record number, etc.
HIPAA requires covered entities to protect PHI from unauthorized access, use, or disclosure, and to give individuals certain rights with respect to their PHI. A covered entity is an organization that transmits protected health information, including — for example — health plans, health care clearinghouses, health care providers, and anyone who transmits any health information electronically in connection with a transaction covered by HIPAA.
HIPAA also applies to the business associates of covered entities — and this is where HealthTech companies come into play. That’s because HealthTech companies who work with covered entities like healthcare providers have access to and/or handle that covered entities’ PHI — which means they also have to abide by the same standards of protecting it. Some requirements HealthTech companies must meet in order to protect the privacy and security of PHI include HIPAA’s Privacy Rule, Security Rule, and Breach Notification Rule. Let’s take a closer look at each of those now.
The Privacy Rule requires HealthTech companies to use and disclose PHI only as permitted or required by their business associate agreements (BAAs) with covered entities, or as required by law. They must also comply with the minimum necessary standard, which means HealthTech companies must limit their use, disclosure, and request of PHI to the minimum necessary to accomplish their intended purpose.
The Security Rule requires HealthTech companies to implement administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of electronic PHI — also known as ePHI — that they create, receive, maintain, or transmit on behalf of covered entities. They must also conduct risk assessments, train their workforce, and have policies and procedures in place to address security incidents and breaches.
The Breach Notification Rule requires HealthTech companies to notify covered entities of any breaches of unsecured PHI without unreasonable delay and no later than 60 days after discovery. They must also cooperate with covered entities in providing the required notifications to affected individuals, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), and the media if applicable.
Now that you know what HIPAA mandates and why it’s important for HealthTech companies specifically, here's our HealthTech HIPAA compliance checklist to help HealthTech leaders get started thinking through their HIPAA compliance strategy.
We recommend you use this checklist as a strategic tool to make sure your HealthTech company is thinking about the right topics when it comes to HIPAA compliance, not as a way to actually design your security program. Why? Because a risk-based approach to compliance beats a checklist approach every, single, day.
HealthTech companies are involved in developing, producing, and delivering health technologies and interventions that can have significant impacts on the health and well-being of patients, providers, and the public at large. That’s why they should be conducting thorough risk assessments in order to identify the potential threats and vulnerabilities to the PHI that they create, receive, maintain, or transmit. They should also be performing regular internal audits to monitor, audit, and evaluate their compliance activities, as well as designate a privacy and/or security officer to oversee them. This will help HealthTech companies to continuously ensure that their products and services are safe, effective, ethical, and HIPAA compliant.
Given that HealthTech companies often manage high volumes of PHI, ePHI, as well as personal and medical information collected by HealthTech devices — such as wearables, sensors, telehealth tools, and software as a medical device (SaMD) — it’s important that they establish boundaries on that information’s usage and disclosure. HealthTech companies will want to develop a compliance plan that addresses the privacy, security, and breach notification requirements of HIPAA and implement documented privacy policies, procedures, and safeguards.
Whether you’re providing telehealth services, other virtual care options, online appointment schedulers, digital communication channels with providers, or other HealthTech products or services, it's imperative that you strengthen your security protocols to ensure customer data is safe. Implementing administrative, physical, and technical safeguards — including encryption, anonymization, and secure data transmission methods — can help you ensure that customers’ data is safeguarded and can also help you avoid potential HIPAA violations that could result in hefty fines.
HealthTech companies will want to ensure they’re conducting mandatory workforce training in compliance and cybersecurity on at least an annual basis. This will help your business foster an ongoing culture of compliance and security awareness — all while ensuring everyone’s on board to help your company stay compliant. This is especially important in a space like HealthTech where tech — and the risks it poses — are constantly emerging and evolving. In fact, driven by the increasing demand for innovative solutions to address the challenges and opportunities in the healthcare sector, the global HealthTech market is estimated to reach USD 1303.9 billion by 2033.That’s going to be a lot of change — fast — and your people need to stay abreast of what’s changing in the industry.
Document everything related to your compliance efforts, including detailed documentation of your risk analysis, compliance plan, privacy policies and procedures, training records, incident management and reports, and your breach notifications. Additionally — and this is just as important — retain those records for compliance verification now and in the future. This act of documentation can not only help you ensure HIPAA compliance, but also manage and maintain your products and services throughout their lifecycle while improving their performance, efficiency, and innovation by learning from data and feedback.
We see you. You’re out there on the cutting edge of health technology dealing with emerging risks. This is why it’s especially important for you as a HealthTech company to identify your unique risks with a risk assessment like Strike Graph's integrated risk assessment. This will allow you to tailor your security program to your unique HealthTech business vulnerabilities — some of which the rest of the healthcare industry may not even be privy to yet — by assigning risk ratings, adding owners to each risk, linking pre-mapped controls from one or more frameworks, and updating risks as your company grows and changes. Not only will this mean you won’t have to waste time on unnecessary security tasks that don’t apply to your company, you’ll also be able to use your analysis to craft a risk-based HIPAA approach.
A risk-based approach to compliance is incredibly important for HealthTech companies dealing with emerging technologies that process high volumes of PHI. Strike Graph's all-in-one compliance platform allows your HealthTech company to tailor your HIPAA compliance plan to your company's unique needs — like high volumes of data — using our in-platform risk assessment. We empower you to mitigate your risks with AI and automated features like HIPAA-mapped controls and automated evidence collection. And, Strike Graph's HIPAA certification means you can prove HIPAA compliance to potential customers — and that’s way better than just telling customers you're following regulations.
If HealthTech companies want to stay in business they need to reach and maintain HIPAA compliance. In a highly competitive market where new tech, products, and services are constantly emerging, HIPAA compliance keeps you in the game. Companies that fail to comply with HIPAA may face civil and criminal penalties, and also reputational damage and loss of trust from customers and partners. That’s why it’s essential that you understand your responsibilities and obligations as a HealthTech company under HIPAA, and start taking the first steps toward HIPAA compliance.
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