What are you looking for from your telemedicine platform? If I had to guess, I’d say you probably prioritize the ability to deliver responsible, evidence-based care. You likely also want an agnostic telehealth solution that gives you clinical control and keeps your patients with the doctors they already know and trust.
But what about compliance? Specifically, the compliance certifications for the telemedicine equipment you use to treat your patients such as data-capturing devices?
If you think those certifications aren’t that important, you’re not alone. You may not even be sure what compliance certifications to check for – again, you’re in good company.
But compliance plays a significant role in delivering quality virtual health and protecting data. Today, in the first of a series on telemedicine security and compliance, we’ll talk about a few of our methodologies as well as certifications and their impact on patient care, hospital success and provider productivity.
Evaluating Vendor Compliance
First, there’s one rule of thumb you can count on: a vendor who doesn’t list their specific equipment certifications doesn’t have them. Any telemedicine vendor who can provide compliance will let you know it. That said, look for these certifications when evaluating a virtual health platform:
ISO 13485:2016 Certification
Any telemedicine vendor who supplies your provider’s medical devices should have this certification. It represents an international quality management system standard for manufacturers and it indicates the vendor has a firm understanding and control of their device manufacturing – especially diagnostic equipment like cameras and software. (If you weren’t sure, telemedicine software is considered a medical device.) It also indicates that your vendor is complying with regulatory and statutory requirements.
ISO 9001:2015 Certification
This certification is the internationally recognized standard for Quality Management Systems (QMS). More than 1.1 million certificates have been issued to organizations in 178 countries. It evaluates your vendor’s quality management system performance and assists in developing a management system that aligns quality and business strategy.
ISO27001 and ISO27002 Certifications
These certifications address the cybersecurity standard for information protection, demonstrating that your vendor has put their platform through intensive security requirements.
If your telemedicine solution involves federal systems, it should comply with the Federal Information Security Management Act (FISMA). This legislation includes a framework to protect U.S. government information and assets, including federal government data security.
FISMA is similar to ISO27001 and ISO27002 but applies a cybersecurity standard to the federal space – requiring a significant overhaul of security frameworks and demanding evidence of controls for logs, auditing, pen testing and other security program components.
U.S. Food and Drug (FDA) Registrations
FDA registrations of medical devices are also important. Some devices require FDA approval if used in the U.S.; vendors who manufacture them must register annually. The criteria to meet registration standards is ISO 13485:2016 certification.
The Path to Protected Care
So why are these compliance quality standards so critical? The answer is that they prove your telemedicine equipment has passed assessments for the following standards:
- Reliable performance
- Data protection
- FDA safety
All of those standards are a must for any virtual medical consultations. If a telemedicine station malfunctions during a remote specialty consult, that means the appointment must be rescheduled. A malfunction during an important procedure could impact the patient’s outcome. If cybercriminals are able to infiltrate the system and steal protected health information (PHI) during a visit, the patient could become a victim of identity theft and the hospital or practice could suffer the financial repercussions of a breach.
That’s why GlobalMed solutions already have compliance certifications locked down – so when you use our hardware stations, software or devices, you’re protected right out of the gate. When providers choose a virtual health platform without the right certifications, they have to do their own compliance groundwork – an arduous project involving considerable staff hours. Instead our compliance certifications like ISO 13485:2016, ISO 9001:2015 and FISMA let your health system and your patients focus fully and safely on virtual care.
Simply put, GlobalMed takes patient safety and protection seriously. We’ve invested significantly in the systems and processes required to achieve compliance with multiple protection methodologies. That includes U.S. government standards, which has allowed GlobalMed to become the telemedicine provider for the White House Medical Unit and Air Force One. Our virtual health applications, hardware and software meet the standards of the U.S. Defense Health Agency. That means we build the most advanced security and compliance in the industry into all our solutions – so that our clients in the commercial enterprise space, such as hospitals, physician groups and workplaces, benefit from the same world-class compliance.
Device certifications may not always seem like the most fascinating aspect of the telemedicine space. But they are the bedrock of responsible virtual medicine, information protection, and optimal patient outcomes. As you create or extend your telehealth offerings, keep a compliance checklist in mind. It could ultimately make or break the success of your virtual care program.