Virtual care and telemedicine services still suffer market penetration, user privacy, and regulatory concerns. Regulations are still evolving as technology evolves and is likely to remain a bottleneck to new product launches.
Listed below are the key regulatory trends impacting the virtual care and telemedicine theme, as identified by GlobalData.
Telehealth regulation was eased to make it easier for patients to continue to access healthcare while limiting exposure to Covid-19. In the US, waivers allowed telehealth to be accessed outside of rural areas, and many temporary codes for telehealth reimbursement covered in the 2021 physician fee schedule.
Software as a medical device regulations
In Europe, the new Medical Device Regulation and In Vitro Diagnostic Device Regulation includes a Medical Device Software (MDSW) consideration. A software digital health app will qualify as a “medical device” if it is intended to be used for one or more of the medical purposes specified in the definition of a medical device or in vitro diagnostic, which include, among other things, diagnosis, treatment, and monitoring of a disease, injury, or disability.
On the other hand, Food and Drug Administration (FDA) policies on apps are based on function not on platform. The FDA intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were not to function as intended. This is a significant difference from the European Union (EU) approach, which may consider any software for regulation which is intended to benefit a patient.
Globally, regulations around the connected patient theme, especially telehealth reimbursement, have continued to ease, allowing for easier access for patients. The Covid-19 pandemic has accelerated this trend. It is likely that many of the reimbursement policies for telehealth set during the pandemic will remain after the pandemic ends. For example, the US Centers for Medicare & Medicaid Services (CMS) has continued to ease regulations around telemedicine services and has proposed to expand its coverage beyond the Covid-19 pandemic.
The CMS is a US federal agency that administers and regulates healthcare reimbursement for the largest healthcare programmes in the country. The CMS sets policies and guidelines about what healthcare services and products can be reimbursed, as well as how they can be reimbursed.
Health Insurance Portability and Accountability Act (HIPAA)
The HIPAA was enacted in 1996. It is a US legislation that protects medical data privacy and security. It provides guidelines to ensure compliance related to the security and proper management of confidential information.
General Data Protection Regulation (GDPR)
The GDPR was introduced in the European Union (EU) in May 2018. It is a regulation in EU law about data protection and the privacy of EU and European Economic Area residents. In the first year of its enforcement, more than 89,000 personal data breach notifications were sent to EU data protection supervisory authorities (DPAs), while over 144,000 queries and complaints were made to DPAs by individuals who believed their rights under the GDPR had been violated. Authorities have begun using the powers provided by the GDPR to levy significant fines on non-compliant companies.
This is an edited extract from the Virtual Care and Telemedicine – Thematic Research report produced by GlobalData Thematic Research.