Regulatory requirements are the cornerstone of any laboratory. In order to operate and do business just about anywhere, labs must operate within strictly defined rules to ensure privacy, workplace safety, and accurate results. But, as many in the industry have noted, regulations are slow to catch up to new developments within the field. 

The international requirements for medical laboratory quality and competence are described in the ISO 15189 standard.

As part of the process for ISO 15189 accreditation, businesses must provide evidence demonstrating how their laboratory conforms to each condition. Since the early 2000s, ISO 15189 has emphasized the competence of laboratories to perform specified tests, not just mere compliance with requirements.

As science and healthcare continues to evolve, regulation will continue to evolve with it. Remote diagnostics is one such area where accreditation, regional, and federal laws are still adapting to meet public health demands. Let’s explore what has changed so far, what hasn’t, and what laboratories should expect in the future.

A Necessary Leap for Health Testing

During the COVID-19 pandemic, one of the early regulatory exemptions enabled the use of remote work in clinical laboratories and pathology. This allowed pathologists to continue to provide care for our patients in a safe environment — for example, by enabling remote review of microscopic slides, which is essential for cancer diagnostics. Without this exemption, many labs would have ground to a halt – and many patients would have waited weeks, or perhaps months, for much-needed medical results. 

The regulatory exemptions included one key component: they removed the need to obtain and maintain a separate home license for remote review of diagnostic materials as long as certain conditions were met. These conditions ensure all other requirements of the Clinical Laboratory Improvement Amendments (CLIA) are maintained. These regulatory exemptions facilitated timeliness of diagnosis and assured quality of patient care for those who opted to establish remote work procedures or testing processes. Nontraditional diagnostic models, such as remote sample analysis and at-home sample collection, show a great deal of promise. However, regulations haven’t quite caught up with the times. The CLIA was last updated in 1988– before the internet took off, before the first smartphone was ever manufactured, and long before anyone ever considered the need to do health testing at home.

The Limitations on Remote Diagnostics

As already mentioned, specific exemptions had to be made in order to allow the distribution of self-collected test kits during the height of the pandemic. 

However, in some states such as New Jersey, New York, and Rhode Island, it is incredibly difficult to distribute self-collection testing kits to patients. In New York, residents can only access self-testing kits when prescribed by a doctor. Residents in New Jersey and Rhode Island only have access to at-home versions of COVID-19 testing; all other health testing must be done in-clinic. These laws are meant to protect consumers from companies making dubious claims about DNA tests and also ensure patients receive medical advice only from licensed medical professionals. While well-intentioned, these regulations also keep legitimate healthtech organizations from providing remote care that breaks down barriers to access. 

Federally, there are other issues. The existing laws, as stated, are based on an extremely outdated framework that hasn’t kept pace with the current technology. For example, current regulations dictate that a test is regulated based on where it is made – such as by a medical device manufacturer or in a clinical laboratory – rather than its complexity or associated risks. 

In addition to outdated regulations and state laws, the FDA has created some issues for itself. The FDA currently uses its traditional authority over medical devices to regulate tests packaged as kits or dispensed outside labs. However, Lab Distributed Tests (LDTs) are designed, developed, and manufactured within a lab – and are subject to FDA’s enforcement discretion, as there is a dispute over whether these tests count as medical devices or an extension of lab services. This stance by the FDA has left itself without an efficient or clear mandate to oversee these products. 

Change on the Horizon

New legislation seeks to modernize the rules and regulations surrounding remote diagnostics and accreditation. 

The Verifying Accurate Leading-edge IVCT Development Act, or VALID Act (S. 2209 and H.R. 4128), updates the FDA’s authority for overseeing diagnostic tests used to screen blood and tissue. Diagnostic technologies and sample collection devices have undergone major advances just in the past ten years alone. Simple and sophisticated tests alike are now capable of going remote. Whether it’s checking a patient’s cholesterol levels or searching for a specific biomarker in the epigenome, at-home self collected tests are accurate, viable alternatives to their on-site counterparts. 

The VALID Act would create a consistent standard for all tests, regardless of the facility they were developed in, as well as a modern regulatory framework that’s better adapted for new and emerging technologies. This would allow the FDA to provide a consistent and efficient level of oversight based on the test itself, not its manufacturer. It would also ease the headaches of lab managers around the country who are considering implementing remote diagnostics. 

The Current State of Remote Diagnostics

Regulations for remote diagnostics remain, for the moment, very outdated. Accredited labs who wish to launch their own remote diagnostic processes within the US are free to do so – so long as they don’t operate in states with explicit restrictions on these processes. Other than the recent exemptions in 2020, the FDA has offered no updated regulations for laboratories in regards to at-home diagnostics. 

As the industry continues to evolve, so will the regulations that ensure our patients receive high-quality, accurate results. Until then, labs will have to operate off of outdated rules and regulations while they continue to innovate.