Legal and Regulatory Hurdles in Digital Pathology and Telepathology

The Food and Drug Administration’s (FDA) approval of two whole slide imaging (WSI) systems for primary diagnosis in the last couple of years has helped spur adoption of digital pathology by laboratories, but there still remain a number of regulatory and legal concerns surrounding digital pathology and telepathology, including licensing requirements, data privacy, consent, and quality control.

Philips’ IntelliSite Pathology Solution for primary diagnosis in surgical pathology received FDA approval in April 2017, followed by approval of Leica Biosystems’ Aperio AT2 DX System in May 2019. While digital pathology systems have been in use in the United States for years, overall adoption of this technology has lagged behind adoption by laboratories in Europe, Canada, and Singapore, according to an article in the Archives of Pathology & Laboratory Medicine.¹ However, early experience from these laboratories indicates that at least 95 percent of cases can be reported digitally without the need to defer to glass slides.

Whole slide imaging (WSI) technology provides pathologists with an ability to archive, review, analyze and share their digital slides. This gives pathologists and laboratories the opportunity to engage in telepathology, digitize slides for quality purposes, education, and documentation, says Anil Parwani, MD, PhD, president-elect of the Digital Pathology Association and director of anatomic pathology at The Ohio State University. Parwani is also director of pathology informatics and director of the digital pathology shared resource at The James Cancer Hospital at Ohio State.

Digital pathology is useful not only for pathologists but also for many patients who have an opportunity to have their cases reviewed by recognized experts, which can improve diagnosis and potentially affect outcomes. Marilyn Bui, MD, PhD, scientific director of analytical microscopy care at Moffitt Cancer Center in Tampa, immediate past president of the Digital Pathology Association and vice chair of the College of American Pathologists (CAP) Digital Pathology Committee, says that digital pathology that gives rise to computational pathology can allow pathologists to generate more data from the patients’ tissue and cells and provide more actionable diagnostic, prognostic, and predictive information to guide effective and quality patient care.

“With computer algorithms and training, digital pathology lets us see things we cannot see with the naked eye,” she says. “The combination of the naked eye and artificial intelligence can be very powerful in improving diagnostics.”

Even so, fewer than 20 percent of laboratories in the United States are using digital pathology for secondary diagnosis while less than one percent of labs use it for primary diagnosis, estimates Parwani. Among the barriers to adoption often cited are cost, data storage requirements, change in workflow, and fear of pathologists in using new technology.

Still, the number of laboratories expected to adopt digital pathology and venture into telepathology is expected to grow significantly in the next decade, which means that pathologists will need to consider telemedicine-specific regulations, state licensure requirements, and privacy and data concerns when determining whether to practice across state lines.

Licensing

For an American Board of Pathology certified pathologist, no additional certificate is needed to read slides digitally. For the state the pathologist practices in, medical licensing is typically handled by state medical boards. While a pathologist does not need to be licensed in a particular state to consult or render a secondary diagnosis, the pathologist does need to be licensed in the same state where a primary diagnosis is rendered in a CLIA-certified laboratory setting.

The Interstate Medical Licensure Compact, which encompasses 29 states, the District of Columbia, and the Territory of Guam, offers an expedited pathway to licensure for qualified physicians seeking to practice in multiple states, according to Amy Lerman, an attorney with Epstein, Becker and Green in Washington, DC. Under this agreement, licensed physicians can qualify to practice medicine across the state lines within the compact if they meet the agreed upon eligibility requirements. The application process is expedited by leveraging the physicians’ existing information previously submitted in their state of principal license. Once qualified, the physician may select any number of compact states in which they wish to practice.

“The compact makes it much easier to get licensed in another state that is covered by the agreement,” explains Lerman. “But pathologists would still need to go through the full licensing process in states where the compact is not recognized.”

Data security and privacy

In addition to being licensed in other states where the primary diagnosis is rendered, pathologists practicing telepathology must also follow both federal and state privacy and security laws, including the Health Insurance Portability and Accountability Act (HIPAA), says Lerman. “We advise providers to have privacy policies that are very specific,” she notes. “With more data flowing, it’s more important than ever to protect patient privacy.”

According to the American Telehealth Association (ATA), which has published clinical guidelines for telepathology, all data transmission used in telepathology should be secured through the use of encryption that meets recognized standards.² The ATA also recommends that protected health information and other confidential data only be backed up to or stored on secure data storage locations. Cloud services unable to achieve compliance should not be used for personal health information or confidential data.

Other potential solutions for confidentiality include anonymization of data by removing patient identifiers or limiting user access to stored patient information. Platforms that support secure data transfer and data encryption are an essential element of a successful telepathology program.

If WSI is used for diagnostic or other related clinical purposes, procedures must be in place that ensure that sites using WSI provide reasonable and expected confidentiality and data security in both data storage and data transmission. The security and privacy requirements of HIPAA apply, as they would for any other potential use of protected health information (PHI). Procedures might include message security, system and user authentication, activity logs, and access restrictions.

With respect to patient identification, as is the case for any laboratory analysis, processes, procedures, and training must be in place to ensure that patient identification linked to glass and digital slides is accurate, maintained, and secure. There are multiple ways to ensure positive patient identification, including use of verbal communication, barcodes, or images of slide labels.

Consent

Individual states may also have varying requirements regarding patient consent, which is another area for pathologists practicing telepathology to consider. “The standard is no different just because you’re doing this via telehealth,” says Lerman. “We advise providers to be very clear about what patients are consenting to.”

While CMS does not require that an informed consent be obtained from a patient prior to a telehealth-delivered service taking place, a majority of states either require informed consent be obtained within their Medicaid program or in their statute or rules regulating health care professionals, according to the Center for Connected Health Policy.

Quality control

While the FDA regulates the companies that make digital pathology systems, pathologists themselves— whether or not they practice telemedicine—are regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and must meet CLIA quality requirements. Quality control portions of CLIA apply to digital pathology, including the analytic phase of testing, which requires monitoring the testing of personnel, the test system and the laboratory environment.

CAP has developed proficiency testing in evaluating the quality of whole-slide images through its Histo- QIP program. Additionally, CAP’s whole-slide imaging validation guideline, the HER2 immunohistochemistry quantitative image analysis guidelines,³ and the digital pathology committee are the go-to resources for quality improvement in digital pathology, notes Bui.

Whole slide imaging systems must go through independent validation studies by laboratories if they are to be used for primary clinical diagnostic purposes, according to the CAP guideline.⁴ The validation study should closely emulate the real-world clinical environment in which the technology will be used, should encompass the entire WSI system, and should be revalidated whenever a significant change is made to any component of the WSI system.

Uses of digital pathology that would not be considered a primary diagnostic use include: digital imaging studies for biomarker testing; interpreting digital slides with immunohistochemical or in situ hybridization tests that augment or refine the primary diagnosis; frozen sections using digital imaging, where a glass slide is subsequently reviewed to provide a final diagnosis; and second opinion consultation.

Digital pathology outlook

The verdict is still out on whether digital pathology will replace traditional microscopy any time soon in the United States. “Country-wide adoption of digital pathology is slow, which does not meet the needs of the quality and efficient care that patients deserve,” says Bui. “There are more regulatory hurdles here that they don’t have in Europe.” Even so, Bui believes digital pathology has great potential for improving the efficiency and accuracy of pathology diagnosis through the use of artificial intelligence.

Despite the regulatory and cost hurdles, Parwani does foresee a time when all pathology diagnoses will be made digitally. “It’s going to take some time, maybe 10 years,” he says. “But I do think we’ll start to see barriers fall.”

References

1. Evans, Andrew J., et al. "US Food and Drug Administration approval of whole slide imaging for primary diagnosis: A key milestone is reached and new questions are raised." Archives of Pathology & Laboratory Medicine 142.11 (2018): 1383-1387.

2. Pantanowitz, Liron, et al. "American Telemedicine Association clinical guidelines for telepathology." Journal of Pathology Informatics 5 (2014).

3. Bui, Marilyn M., et al. "Quantitative image analysis of human epidermal growth factor receptor 2 immunohistochemistry for breast cancer: Guideline from the college of American pathologists." Archives of Pathology & Laboratory Medicine 143.10 (2019): 1180-1195.

4. Pantanowitz, Liron, et al. "Validating whole slide imaging for diagnostic purposes in pathology: guideline from the College of American Pathologists Pathology and Laboratory Quality Center." Archives of Pathology and Laboratory Medicine 137.12 (2013): 1710-1722.