The need for speedy and more complete access to data is instrumental for healthcare providers, researchers, pharmaceutical, biotech and device companies and public health authorities as they work to quickly identify infection rates, disease trends, outcomes, including antibodies, and opportunities for treatments and vaccines for COVID-19.

A variety of data sharing and collaborations have emerged

Background: Issuing Florida’s Emergency Order

On March 16, 2020, Florida Surgeon General Dr. Scott Rivkees signed, stamped and finalized Emergency Order 20-002. In doing so, Florida joined what would become the vast majority of states in modifying licensure requirements for physicians in response to the Coronavirus (COVID-19) emergency.

The surgeon general’s order waived licensing requirements for out-of-state healthcare professionals, advanced life support professionals and basic life support professionals so that they could render services in Florida for the purposes of preparing for, responding to and mitigating any effect of COVID-19. In addition to waiving licensing requirements for in-person services, the order exempted out-of-state physicians, osteopathic physicians, physician assistants and advanced practice registered nurses from licensing requirements governing the provision of telehealth. The order also impacted emergency medical services training programs, physical examination requirements for physician certifications, prescription drug distribution and controlled substance prescription renewals (including medical marijuana). The order was to expire 30 days after signing—April 15, 2020.


Continue Reading Florida’s Extension of its COVID-19 Out-of-State Provider Waiver: A Sign of the Times

On April 2, 2020, the Federal Communications Commission (FCC) launched the $200 million Coronavirus (COVID-19) Telehealth Program contemplated in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Telehealth Program is distinguishable from the broader Connected Care Pilot Program, which will make an additional $100 million in federal universal service funds available for telehealth over the next three years.

Telehealth Program

Notwithstanding telehealth’s advantages, most low-income Americans are unable to utilize telehealth services due to their lack of consistent, broadband internet connection. Furthermore, some providers are limited in their ability to treat patients via telehealth due to the substantial financial and IT investment in developing connected care programs (e.g., purchase of remote patient monitoring devices, telehealth software platforms). The purpose of the Telehealth Program is to support healthcare providers in urban and rural areas, that are responding to the ongoing coronavirus pandemic by maximizing their provision of connected care services and devices. The Telehealth Program will help eligible healthcare providers purchase telecommunications services, information services and devices necessary to provide critical connected care services.

For purposes of the Telehealth Program and Connected Care Pilot Program, “connected care services” are defined as a subset of telehealth that uses broadband internet access service-enabled technologies to deliver care to patients at their mobile location or residence. Only internet-connected devices are covered, not unconnected devices that require the patient to communicate the results to their provider.

Funding will be awarded on a rolling basis until funds are exhausted or the coronavirus pandemic ends. To maximize the $200 million, the FCC anticipates limiting each applicant to $1 million in funding. Further, the FCC has indicated an interest in prioritizing funding to areas especially hard-hit by the coronavirus.

Eligible Healthcare Providers


Continue Reading $200 Million of Funding for COVID-19 Telehealth Program

The Centers for Medicare & Medicaid Services (CMS) continues to loosen the conditions for participation in Medicare, as well as specific reimbursement requirements, to ensure facilities and practitioners are able to practice at the top of their license and across state lines without jeopardizing Medicare reimbursement. Unfortunately, as demonstrated when CMS took similar actions over

Government, media and industry have all pointed to the potential for telemedicine to assist in combating the COVID-19 pandemic. In addition, steps have been taken by the government to ease the burdens associated with the use of telemedicine during this crisis. Unfortunately, the complexity of the regulatory infrastructure has left a fair amount of confusion

On March 4, 2020, the House passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, a bipartisan bill to aid in COVID-19 preparedness and response. The bill includes, among other things, provisions that waive certain telehealth requirements during the COVID-19 public health emergency to ensure Medicare beneficiaries can receive telehealth services at home

In our global economy, Coronavirus (COVID-19) raises serious concerns for employers in all industries. Workers may be on the front lines caring for patients and developing vaccines, travelling for business, or in close contact with individuals who travel or may have been affected. At this time, there is no vaccine or medication approved to prevent

As the number of confirmed COVID-19 cases in the United States grows, healthcare providers are stepping up their response planning. To combat the spread of COVID-19, the Centers for Disease Control and Prevention (CDC) urged healthcare systems and providers to deploy all of the resources necessary to ensure health system preparedness. The CDC recommended the

When it comes to market success for digital tools in the health sector, business strategy can be far more complex than in other industries. Understanding customer-driven market trends is important, but healthcare’s complexity can camouflage customer demand and its regulatory ecosystem adds layers of additional considerations.

Customer Demand and Digital Solutions

The convenience, competitive pricing, answers-at-your-fingertips responsiveness and hyper-personalization delivered by top technology brands and their integration into other industry sectors has created an expectation for digital health solutions that deliver the same experience.

In some instances, consumers are finding the solutions. For example, telemedicine is gaining momentum as consumers discover that digital interactions with high-quality providers are oftentimes more convenient and less expensive than face-to-face encounters. Other tools are providing access to prescriptions, better health condition management solutions, better information sharing enabling smoother transitions among care settings, and more efficiency in everything from hospital operations to scheduling appointments to identifying in-network care options.

When it comes to business strategy, however, digital health solutions need to recognize that consumer pressures are frequently at odds with existing incentives within care delivery systems and, perhaps legal and regulatory requirements. Accordingly, it is critical not just from a compliance perspective but also from a business strategy perspective to navigate the healthcare industry’s unique market and regulatory dynamics.

Balancing Demand with Reality

Continue Reading Digital Health Business Strategy: A Careful Balance

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory approaches to reducing barriers to the development and adoption of artificial intelligence (AI) technologies. Implementing agencies are agencies that conduct foundational research, develop and deploy AI technologies, provide educational grants, and regulate and provide guidance for applications of AI technologies, as determined by the co-chairs of the National Science and Technology Council (NSTC) Select Committee. To our knowledge, the NTSC has not yet determined which agencies are “implementing agencies” for purposes of the Memorandum.

Submission of Agency Plan to OMB

The “implementing agencies” have 180 days to submit to OMB their plans for addressing the Memorandum.

An agency’s plan must: (1) identify any statutory authorities specifically governing the agency’s regulation of AI applications as well as collections of AI-related information from regulated entities; and (2) report on the outcomes of stakeholder engagements that identify existing regulatory barriers to AI applications and high-priority AI applications that are within the agency’s regulatory authorities. OMB also requests but does not require agencies to list and describe any planned or considered regulatory actions on AI.

Principles for the Stewardship of AI Applications

The Memorandum outlines the following as principles and considerations that agencies should address in determining regulatory or non-regulatory approaches to AI:

  1. Public trust in AI. Regulatory and non-regulatory approaches to AI need to be reliable, robust and trustworthy.
  2. Public participation. The public should have the opportunity to take part in the rule-making process.
  3. Scientific integrity and information quality. The government should use scientific and technical information and processes when developing a stance on AI.
  4. Risk assessment and management.A risk assessment should be conducted before determining regulatory and non-regulatory approaches.
  5. Benefits and costs. Agencies need to consider the societal costs and benefits related to developing and using AI applications.
  6. Flexibility. Agency approaches to AI should be flexible and performance-based.
  7. Fairness and nondiscrimination. Fairness and nondiscrimination in outcomes needs to be considered in both regulatory and non-regulatory approaches.
  8. Disclosure and transparency. Agencies should be transparent. Transparency can serve to improve public trust in AI.
  9. Safety and security. Agencies should guarantee confidentiality, integrity and availability of data use by AI by ensuring that the proper controls are in place.
  10. Interagency coordination. Agencies need to work together to ensure consistency and predictability of AI-related policies.


Continue Reading US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence