Digital Health Regulations in US After COVID-19: What’s Changed and How to Navigate It [2022]

Digital Health Regulations in US After COVID-19: What’s Changed and How to Navigate It [2022]

17 November 2020 • 5 min read

The COVID-19 worldwide pandemic has impacted virtually every aspect of society across the globe. Populations in countries around the world have had to radically change their way of life as governments struggle with implementing measures designed to curb the spread of the virus. As winter approaches in the Northern Hemisphere, it appears that more stringent actions, including additional lockdowns, may be necessary to protect the health of the population and the viability of the healthcare system.

The medical establishment has been greatly affected by the demands of providing testing and care to individuals exposed to COVID-19. One aspect of healthcare in particular that has had to swiftly adapt to the world’s new reality is the use of telehealth in medicine. Healthcare providers have had to increase their use of solutions based on remote interaction with patients to help reduce the spread of the extremely contagious disease. Telemedicine rules and regulations may have to be quickly modified to allow the maximum potential of eMedicine to be reached.

What are Healthcare Regulations for Telehealth Applications?

The current trends in telemedicine in the United States and around the world indicate the need for increasing the availability of remote solutions to protect both patients and healthcare workers from exposure to COVID-19. In some cases, the need for greater access to these services is contrary to the telemedicine laws and regulations that various societies have previously implemented.

Data privacy is the underlying reason for most telemedicine regulations. Sensitive personal information needs to be shared between patients and practitioners, and its safety as it is transmitted electronically is of great concern to all parties. The main goal of telehealth service regulations is to protect the privacy of this sensitive data from unauthorized access while enabling healthcare providers to address their patients’ needs remotely. There is also a need for regulations to be devised that address the issue of telemedicine and reimbursement which has impeded the widespread adoption of electronically delivered medical services.

Read our experience in telehealth app development and doctor appointment scheduling software development.

Telehealth in the U.S. Before Covid-19

Recent trends in telemedicine in the U.S. indicate an increased acceptance of this new way to deliver medical expertise is gaining traction among doctors and patients. Between 2015 and 2018, there was a 340% increase in the number of physicians who have adopted telehealth solutions by Amwell’s physician survey. Patients were also more willing to remotely consult with healthcare providers for a wide range of services such as wellness checks, digital mental health services, prescription questions and refills, pre and post-surgery appointments, and pregnancy checkups.

Read also: How to Build a Psychological Therapy Application

Telehealth in the U.S. Before Covid-19

There are numerous agencies and regulations related to healthcare in the U.S. that also impact the use of telemedicine. Among the most important healthcare regulations in 2020 are:

  • A combination of the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act addresses the security and privacy of personal health information (PHI).
  • The 21st Century Cures Act is designed to foster interest in telemedicine software development and the introduction of new and innovative products to the patient community.
  • Multiple agencies such as the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) provide medicare telemedicine regulations that impact how insurance companies handle claims made for virtual meetings with healthcare facilities. The subject of telehealth insurance reimbursement is of great concern for the economic well-being of providers and patients. New regulations introduced in March 2020 require Medicare Advantage and other qualified health plans to conform to the department’s interoperability guidelines to be eligible for reimbursement.
  • Additional regulations on telemedicine advertising and claims are developed and enforced by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). These include regulations affecting healthcare software development and application development.

These agencies and regulations were in place as the pandemic hit and are still the basis for the remote telemedicine solutions being used and developed to help combat this deadly virus.

Read Softermii experience in mHealth app development.

Changes in Telehealth Regulations Driven by the Pandemic

The telehealth challenges faced by the country as it tries to cope with COVID-19 have forced some regulations to be revisited and modified. On January 31, 2020, Secretary of Health and Human Services (HHS) Alex Azar declared the virus to be a public health emergency. The declaration paved the way for changes to be made that temporarily facilitate the use of telehealth solutions. In some cases, these changes may wind up being retained as long-term solutions to expand the scope and availability of virtual medical services.

The following are some of the most impactful changes that have been made since the declaration of a public health emergency.

  • The CMS has expanded the types of services eligible for telemedicine visit reimbursement. This allows millions of individuals to consult with healthcare providers without worrying about exposing themselves to the virus or having financial difficulties due to medicare reimbursement regulations. These changes are set to remain in effect for the duration of the public health emergency. Limiting the ability to obtain reimbursement is one example of how government regulations made healthcare so expensive.
  • Penalties will be temporarily waived by the Office for Civil Rights (OCR) for HIPAA violations that may occur through the use of public electronic communication tools like Skype as long providers demonstrate best-efforts to protect personal information.
  • The Drug Enforcement Administration (DEA) is loosening its digital health regulations regarding the ability of providers to prescribe schedule II-V controlled substances to patients with whom they have not had an in-person consultation.

Opportunities for Focused Software Development

The changes and new healthcare regulations in 2020 brought about by COVID-19 have introduced opportunities for digital health app development to address the challenges of delivering telehealth to society at large. There are several aspects of providing remote medical care that lend themselves to telemedicine app development solutions. Here are some specific examples of ways that software developers can furnish the tools required to facilitate the telemedicine revolution.

The creation of more user-friendly and functional telemedicine solutions through the use of WebRTC application development is essential to the growth of the market. Building personalization and enhanced usability into health apps that run on mobile devices will attract patients and healthcare providers who are still uncertain about the benefits of telemedicine.

Security is of even more importance in telemedicine development than in most other types of software. The communication between doctors and patients usually involves the exchange of sensitive information that needs to be protected. Ensuring the safe transmission of personal health information is imperative to the widespread adoption of telemedicine throughout all parts of society.

Healthcare organizations are moving away from proprietary solutions developed by in-house programmers. The market is wide open for small teams that can create affordable and secure solutions tailored to the telemedicine field. A single successful application can wind up being used by millions of patients throughout the country.

It might time to hire WebRTC developers and refocus your applications on the needs of the digital medical marketplace. The current state of the world presents a rare opportunity to combine the excitement of creating cutting-edge technological solutions with the knowledge that your work is helping address the extraordinary needs of the COVID-19 world.

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