Virtual care and telemedicine are still at an early evolutionary stage. They still face regulatory uncertainty, low market penetration, and privacy concerns. As technology evolves, these challenges and circumstances will change.

To understand the industry’s direction, here are some notable regulatory trends.

In the US, the need for care during the COVID-19 pandemic pushed regulators to allow telehealth to be used in non-rural areas to limit people’s exposure to the virus. Telehealth became accessible to more people, and temporary codes were created to allow telehealth reimbursements in the 2021 physician schedule.

Software Regulation in Europe and US

A significant problem for the health regulatory sector has been how to regulate software used in the diagnosis, treatment, and monitoring of patients. The Food and Drug Administration has taken a more liberal approach in the US. It has signaled its intention only to regulate software that could harm a patient if it malfunctions.

In contrast, the approach regulates any software as long as it benefits a patient. In the EU, the relevant laws are the Medical Device Regulation and In Vitro Diagnostic Device Regulation.

Such clarity in the regulatory approach is essential to developers, medical professionals, and hospitals.

The US Centers for Medicare & Medicaid Services is the federal agency responsible for setting regulations on healthcare reimbursement. During the pandemic, they eased limitations on reimbursement to increase access to care at a time of need. Beyond the pandemic, they have continued to reduce regulations on telemedicine by improving the number of services that can be reimbursed.

The EU passed The General Data Protection Regulation in 2018 to clarify how businesses should handle personal data collected from residents in the zone. In the first 12 months after the law came into force, people sent 89000 complaints to the supervisory body. Creating such bodies is crucial because it instills confidence that misuse of personal data is punishable.