Ambient Scribe Compliance: What Every Clinic Must Know

Data breaches in the healthcare industry are something that happens almost every other day. You might have missed some of the news related to this because everything else seems more important these days. However, to nudge you in the data breaches in the healthcare industry, in 2023, almost 725 data breaches were reported, exposing 133 million records.

This makes up a significant portion of data breaches, and we’re not even mentioning the breaches that are not reported. Having said that, let’s have a sneak peek into the financial impact of these data breaches. In 2023, with a 15% increase, the global average cost of a data breach reached an all-time high of $4.45 million.

Since then, a significant improvement has been made, but the use of advanced technologies has further elevated the risk. For instance, many practices across the United States have been using AI for various purposes like data sharing, transcription, etc. And putting this data at risk can be damaging for both practice and patients. 

So, the question is, what can we do about this?

Well, you might know about certain compliances and regulations that you need to adhere to ensure the safety and privacy of your data, right? To give you a nudge, HIPAA, HITECH, ONC, GDPR, etc., are some of the bodies that set up the regulations that you need to adhere to.

And since you’ll be building AI software for your practice, then AI scribing the HIPAA checklist is something that you should refer to. But if you’re following this article till now, then you must have an idea that there is more to uncover.

So, what exactly do you need to know for transcription data privacy, secure voice data strategies, or healthcare ambient AI compliance?

Well, let’s find out in this blog below!

The Compliance Landscape: Understanding Your Regulatory Obligation

Healthcare compliances are quite complicated, and depending on which technology, region, or data you deal with, there can be multiple things that you need to know. So, here are some of the things about healthcare ambient AI compliance that you need to know:

1. Multi-Layered Regulatory Framework: Unlike other industries, the healthcare industry has a multi-layered regulatory framework. For instance, you must be familiar with HIPAA and the HITECH Act, but there are specific state privacy laws that you also need to comply with. Along with that, if you are using AI tools, then complying with emerging AI-specific regulations is also necessary.

2. Unique Ambient AI Risk Factor: The major risk factor for AI scribing frameworks is that there is a risk that these technologies might always be listening and recording things. Along with that, real-time processing, cloud storage, and third-party AI models can provide other risks. 

3. Enforcement Trends & Penalties: Enforcement has become necessary as it is people’s personal data that you deal with. Though these trends have been increasing with time, it is the penalties that you must worry about. For instance, HIPAA violations alone can range from $100 to $1.5 million per year. That is why you must have a compliance monitoring plan in place.

4. Liability Distribution: What we mean by liability distribution is that maintaining security is a collection effort for you as a healthcare practice, AI vendor, and cloud services provider. So, setting which part comes under whom can be of great use to measure accountability.

HIPAA, HITECH, & Beyond: Navigating the Regulatory Maze

Out of all the major compliances, the one that almost covers all the aspects of rules and regulations from other compliances is HIPAA. HIPAA stands for the Health Insurance Portability and Accountability Act, which has been enacted since 1996.

If you explore the intricacies of HIPAA compliance, there are some safeguards that you must know. These safeguards have been divided into the functioning and the aspects it serves of your practice. So, without further ado, let’s get started:

1. HIPAA Administrative Safeguards: Referring to the administrative aspects of the practice, HIPAA requires your software to have certain safeguarding measures, such as role-based access control to access data so that only authorized personnel can access data. Other than that, HIPAA states that everyone in your workforce must be trained on how to use the software and have an incident response plan in place to meet the safety measures.

2. HIPAA Physical Safeguards: Since your digital healthcare infrastructure will be using certain machines, here are certain physical safeguarding measures that HIPAA requires you to adhere to. It requires you to adhere to FDA standards for device control, maintaining workstation security, and media disposal for ambient AI systems. This way, secure voice data practices can be followed, and medical dictation security can be achieved. 

3. HIPAA Technical Safeguards: Concerning the technical aspects of your software, some of the technical safeguards that you need to follow are access controls, maintaining audit logs, maintaining integrity in practice, and ensuring security during the transmission of data between two different systems.

HITECH Act Breach Notification Rule

This rule of the HITECH Act requires special attention, given its uniqueness and importance. This has been an important aspect in ensuring transparency in your processes. It states that every covered entity (healthcare practices) and their business associates must inform the individuals and the Department of Health & Human Services (HHS) in case of a breach of unsecured Protected Health Information (PHI).

This makes one of the first responses in case of any security breach, etc.

The Importance of Business Associate Agreement

In this entire healthcare ambient AI compliance affair, the Business Associate Agreement or the BAA is going to play a critical role. It basically is an agreement between you and your vendor, which clearly brings you under compliance to ensure the safety and security of the AI-powered software you are building.

Patient Consent & Transparency: Building Trust Through Communication

The entire digital healthcare landscape works on one thing, which is patient consent. In simple words, only if the patient gives you permission to provide them with digital care can you provide them with a virtual case. And since this is the start of the patient’s care journey with you and the chances of errors that come with this, many healthcare practices want specific patient consent AI tools to be integrated into their practice.

In this section, let’s see some of the things you need to consider with respect to patient consent and how you can ensure transparency in this process:

1. Informed Consent Requirements: In this patient consent AI tool, your entire software should be healthcare ambient AI compliant. To bring credibility and transparency in the process, the patient must know about the transcription data privacy aspects, from recording and data processing to storage and beyond.

2. Consent Documentation Standards: In the patient consent form, you lay out the consent and everything that comes in as an aspect of care delivery and permissions. That is why a written consent form must be clearly documented. Also, to bring ease in gaining patient consent, you must acknowledge the use of digital technologies and have a consent management system in place to keep a record of it.

3. Opt-Out Mechanisms: Some patients might not be able to agree with everything that you mention in your consent form. In such cases, you as a provider must respect their choices and give them the necessary options for some necessary aspects. Still, if a patient wishes to opt out of the agreement, then they should have a smooth process for withdrawing their consent.

4. Transparency Obligations: With respect to the transparency that you need to bring in your processes and care delivery, having clear communication with patients and providers about AI capabilities, its limitations, and data handling must be stated.

Technical Safeguards: Encryption, Access Controls & Audit Trails

The technicalities of healthcare ambient AI compliance are quite complicated, and understanding them can be difficult for someone from a non-technical background. Breaking this down in simpler terms, here is what you need to know about technical safeguarding that comes in your AI scribing HIPAA checklist:

1. End-to-end Encryption Standards: You must have end-to-end voice data encryption in place to ensure medical dictation security both during transmission and at rest. Along with that, special attention to the key management strategy must be implemented so that your keys are always secure, which makes up almost all the aspects of data decryption. One of the best practices is to follow the standard cryptographic protocols.

2. Access Control Architecture: Your digital architecture for the flourishing of the ecosystem is extremely important. It always serves as the foundation for access controls. The core aspects of this architecture that you need to know are role-based permissions, multi-factor authentication, and privileges access management so that who can access what data can be crystal clear.

3. Comprehensive Audit Logging: Audit logging is another core aspect; in this, you need to implement activity tracking for every log-in and activity that is happening in your system. Along with that, it should be able to enable system monitoring and have forensic capabilities so that you leave no leaf unturned.

4. Data Retention & Disposal: There are often instances where you delete certain data, and even often, you need that data sometime sooner. That is why secure deletion protocols must be implemented. Along with that, you must also implement data retention strategies that schedule it to always have a backup of the data. However, for this aspect also, there is certain healthcare ambient AI compliance that you need to follow.

Vendor Due Diligence: Evaluating Ambient AI Compliance

The role of your healthcare software development vendor or, in this case, the AI-powered software development vendor is quite, if not the most critical. So, here are some vendor due diligence about evaluating these claims:

1. Compliance Certification Verification: Certain healthcare ambient AI compliance certificates can validate vendor claims. So, ensure that either or all the compliance certifications like SOC 2 Type II, HITRUST, FedRAMP, HIPAA, etc.

2. Business Associate Agreement Negotiation: When you come to an agreement with your vendor, the BAA is the common ground that binds you together. That’s why you need to add all the essential clauses, liberty allocation, and compliance obligations clearly so that no leaf is left unturned.

3. Security Assessment Framework: Ask the right questions when it comes to ensuring security before your module is delivered. Some of the aspects of this involve doing penetration testing? How do you assess the vulnerabilities in your system, and what is the process of ongoing security monitoring?

4. Vendor Risk Management: Your vendor can also put you at risk. So, have a solid vendor risk management strategy in place. Some of the things to consider in this are financial stability, incident response capabilities, and long-term viability assessment.

Frequently Asked Questions