Healthcare

LEGAL AND REGULATORY FRAMEWORK FOR DIGITAL HEALTH – TELEMEDICINE PRACTICE GUIDELINES

In a significant move, the Ministry of Health and Family Welfare (“MoHFW”) on March 25, 2020 has issued the Telemedicine Practice Guidelines (“Guidelines”) for enabling Registered Medical Practitioners (“RMPs”) to provide healthcare using telemedicine. As per the Guidelines, ‘telemedicine’ is the delivery of health care services, where distance is a critical factor, by all the healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, all in the interests of advancing the health of individuals and their communities.

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HOW TO ASSIST WITH THE MEDICAL SUPPLY SHORTAGE

As the COVID-19 pandemic continues to develop across Canada, medical professionals anticipate that there could be a shortage in medical supplies and equipment. While all levels of government have been taking steps to respond to COVID-19 and to obtain necessary supplies, they have also reached out to the private sector to assist. Read the full article.

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SAMHSA issues guidance on disclosure of substance use disorder patient information

On March 19, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued guidance on disclosure of substance use disorder (SUD) information during the COVID-19 pandemic national emergency period. READ MORE

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SAMHSA encourages telehealth for substance use disorder patients

Late last week the Substance Abuse and Mental Health Services Administration (SAMHSA) issued guidance encouraging the use of telehealth for substance use disorder (SUD) patients during the COVID-19 pandemic national emergency period. READ MORE

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DEA allows remote prescribing of controlled substances

On March 20, 2020, the Drug Enforcement Administration (DEA) posted guidance allowing DEA-registered practitioners to prescribe controlled substances remotely (e.g., through telehealth) during the COVID-19 national emergency period. READ MORE

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CMS issues guidance on payments for state medicaid telehealth services provided during COVID-19 pandemic

In recent guidance, the Centers for Medicare and Medicaid Services (CMS) intended to help states better understand policy options for paying Medicaid providers using telehealth to deliver patient services in combating COVID-19. CMS has recently been encouraging providers to use telehealth services due to the benefit of increasing access to care while reducing the risks for spread of infection and exposure for vulnerable populations. READ MORE

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Secretary Azar Urges Governors to Take Action to Lift Restrictions to Extend the Capacity of the Health Care Workforce

In response to the growing concerns of the capacity of the health care workforce as a result of the COVID-19 pandemic, on March 24, 2020 the Secretary of Health and Human Services, Alex Azar, issued a letter and associated Guidance to all Governors urging them to take immediate action.  While the federal government, and some states, have admirably waived and relaxed many rules related to the provision of various types of benefits and services, including relaxed telehealth and privacy rules/enforcement, many necessary actions are within the authority of state governments. Presumably, this plea from Secretary Azar is an attempt to “close the gap” between what the federal government has done to remove these barriers and the stringent restrictions of many state licensure laws. Specifically, Azar sets forth eight action items that he is asking Governors and the District of Columbia to consider in order to lift the limits that state rules currently place on licensure, scope of practice, certification, and recertification/relicensure. The action items include:

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Personal Jurisdiction in a Time of Social Distancing

Across the nation, authorities are scrambling to meet the new challenges posed by COVID-19. The United States Centers for Disease Control and Prevention (“CDC”) has recommended that individuals remain six feet apart in order to prevent the spread of COVID-19. On March 13, 2020, the White House proclaimed a national emergency and many State governments have ordered non-essential businesses to close, and residents to self-distance. However, these emergency measures conflict with the rules for personal service of process established by Federal Rule of Civil Procedure 4.

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FDA Eases Device Modification Rules to Expand Availability of Ventilators During COVID-19 Pandemic

On March 22, 2020, the U.S. Food and Drug Administration (“FDA”) issued guidance, for immediate implementation, that aims to increase the availability of ventilators and other respiratory devices needed to address the COVID-19 pandemic.  While FDA urges health care facilities to use, wherever possible, FDA-cleared standard full-featured ventilators to treat COVID-19 patients (as well as other patients requiring ventilatory support), FDA will allow a more flexible approach to modifications to these devices to help boost manufacturing capacity and supply.  FDA also took the opportunity to lay out guidelines that encourage submission of Emergency Use Authorization (“EUA”) applications for devices not marketed in the United States, continuing an unprecedented Agency response to the pandemic.

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FDA Confirms That At-Home Collection Kits Are Not Authorized for Use with COVID-19 Tests

On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist laboratories and commercial manufacturers in development of diagnostic tests for the novel coronavirus (“COVID-19”) during the ongoing pandemic.

During the first week of implementation, questions arose regarding the extent to which the Emergency Use Authorization (“EUA”) pathway to market, as described by the Policy, covers at-home tests. The Policy specifically provides that it “does not apply to at home testing” (emphasis added). However, the industry still questioned the FDA’s stance on the use of at-home collection kits, allowing a consumer to self-collect a specimen and mail in a swab or similar collection device to a laboratory running an FDA-approved COVID-19 test.

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