S. 3983, the PATCH Act, would establish cybersecurity requirements for device manufacturers

S. 3983, the Protecting and Transforming Cyber Health Care (PATCH) Act, was introduced on March 31, 2022 by Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA). The bill would require manufacturers of cyber devices to include in premarket submissions to the Food and Drug Administration (FDA) information on cybersecurity that would demonstrate reasonable assurance of safety and effectiveness through the product lifecycle. Manufacturers would be required to furnish to the FDA a software bill of materials including commercial, open source and off-the-shelf software components included in the device, and to monitor postmarket cybersecurity vulnerabiities.

S. 3904 - Healthcare Cybersecurity Act

S. 3904, the Healthcare Cybersecurity Act, was introduced on March 23, 2022 by Senators Bill Cassidy (R-LA) and Jacky Rosen (D-NV). It has four cosponsors. The Act requires the Cybersecurity and Infrastructure Security Agency (CISA) to assist the Department of Health and Human Services (HHS) in improving cybersecurity in the healthcare sector. CISA would be required to issue a sector-specific report on cybersecurity risks to the health care industry and the public health sector, especially for rural and small to medium healthcare assets, and to assist in training individuals in the health care sector in mitigation of cybersecurity risks.

H.R. 6202 would expand access to telehealth

H.R. 6202 was introduced on December 9, 2021 by Congressman Lloyd Doggett (D-TX-35). The bill would amend the Social Security Act to expand access to telehealth, among other changes. The bill has 67 cosponsors.

H.R. 6000: 21st Century Cures 2.0

H.R. 6000, the 21st Century Cures Act 2.0, was introduced on November 17, 2021 by Diane DeGette (D-CO-1) and Fred Upton (R-MI-6), and currently has 91 cosponsors. The bill addresses several topics relevant to telehealth and digital health, including breakthrough devices.

Title I of the bill addresses various public health initiatives, including study of long covid, and Title II would expand programs for patients and caregivers. Title III incorporates several initiatives affecting the Food and Drug Administration (FDA), including expanding the use of real-world evidence (RWE); requiring communication between the FDA and the Centers for Medicare and Medicaid Services (CMS); and accelerating the timeline for breakthrough and regenerative medicine advanced therapy (RMAT) designation. Title IV, dealing with CMS, would incorporate concepts advanced in several other bills, including increasing access to telehealth under Medicaid and the Children's Health Insurance Programs (H.R. 1397, the Telehealth Improvement for Kids' Essential Services (TIKES) Act; extending the Medicare telehealth flexibilities beyond the expiration of the covid public health emergency (H.R. 1332, the Telehealth Modernization Act); providing for coverage of breakthrough devices (H.R. 4043, the Ensuring Patient Access to Critical Breakthrough Products Act); and expanding access to genetic testing (H.R. 5989, the Precision Medicine Answers for Kids Today Act). Title V provides additional funding for health research.

H.R. 4480 - Telehealth Coverage and Payment Parity Act

H.R. 4480, the Telehealth Coverage and Payment Parity Act, was introduced on July 16, 2021 by Rep. Dean Phillips (D-MN-3). The bill has one cosponsor. The bill would require group health plans and health insurance issuers offering group or individual health insurance coverage to cover telehealth services if the same services would be covered if furnished in-person. Group health plans and insurers would be required to provide benefits under the same terms and with the same cost-sharing requirements as would apply to in-person services, and pay providers the same amount for telehealth as for in-person services. Also, group health plans and insurers could not require that the provider have a prior relationship with the patient, or establish incentives or penalties to discourage telehealth. Group health plans and insurers could waive cost-sharing requirements for diagnosis or treatment of COVID-19. The bill would also expand the definition of "qualifying telecommunications system" to include audio-only communications.

H.R. 2980 - Cybersecurity Vulnerability Remediation Act

The Cybersecurity Vulnerability Remediation Act was introduced by Rep. Jackson Lee (D-TX-18) and authorizes the Director of the Department of Homeland Security (DHS) to identify and disseminate protocols to mitigate cybersecurity vulnerabilities to information systems and industrial control systems, including in circumstances where vulnerabilities exist because software or hardware is no longer supported by a vendor. DHS is to report on how disclosures of cybersecurity vulnerabilities are coordinated, including a description of how privacy and civil liberties are preserved in the collection of vulnerability disclosures. HR. 2980 passed the House of Representatives on July 20, 2021.

H.R. 1205 would authorize grants to improve mental health access from the ER

H.R. 1205, the "Improving Mental Health Access from the Emergency Department Act of 2021", was introduced by Rep. Raul Ruiz (D-CA-36).  It passed the House on May 12, 2021.  This Act would authorize grants to health providers that operate emergency departments, are staffed by medical personnel capable of providing treatment to stabilize acute mental health conditions, and have arrangements in place with other providers of care to provide treatment of acute mental health episodes.  The grants would be used to create, support or expand programs to assist patients treated for acute mental health episodes to transition to an appropriate facility or setting for follow-on care.  Grants could be used for alternative approaches such as telepsychiatry and proactive followup such as telemedicine.

View LinkedIn Profile

Shack Cookies Restrict

This website uses cookies to properly administer the site and improve your experience. Continuing to use this website indicates your acceptance. Please click "accept" to remove this message.