There have been exciting advancements in the digital health space over the past few years that are truly changing lives, but the sector seems to be experiencing a reset as investment drops off. Below, we look at some current investment
Health Care Law Today
Health Care Law Today, published by Foley & Lardner LLP, focuses on legal developments and regulatory issues affecting the healthcare industry. The blog covers topics such as digital health investment trends, telehealth privacy and security best practices, Medicare policy changes including behavioral health service expansions, remote patient monitoring regulations, and compliance with state vaccination requirements for healthcare facilities. It addresses the intersection of healthcare delivery, technology, and law, providing updates on federal and state regulations, reimbursement policies, and risk management strategies relevant to healthcare providers, payers, and investors.
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Telehealth Providers: HHS Issues HIPAA Best Practices
Recognizing the evolving landscape of care delivery and growth of telehealth, the U.S. Department of Health and Human Services (HHS) published a resource guide aimed at assisting telehealth providers in explaining the privacy and security risks to patients that engage in…
CMS Expands Access to Behavioral Health Services; Physician Fee Schedule Expands Billing Providers and Flexibilities
On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) issued its 2024 Physician Fee Schedule final rule (Final Rule) for calendar year 2024 that will, in part, implement some of the most important changes to improve access…
Top 5 Rules for Medicare 2024 Remote Patient Monitoring and Remote Therapeutic Monitoring: What Companies Need to Know
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare program.
The guidance published in the 2024 Physician Fee…
Massachusetts: Proceed With Caution – New Vaccination Criteria for Hospitals and Other Licensed Health Facilities
Following public hearings and at least 78 public comments, at the end of October, hospitals and other facilities licensed by the Massachusetts Department of Public Health (DPH) will have new flexibility to require both flu and COVID-19 vaccinations for personnel,…
New Biden EO on AI Oversight, Development, and Use: Implications for the Health Care Industry
On Monday, October 30, President Biden signed an executive order (EO) aimed at overhauling the governance and oversight of artificial intelligence (AI) and technological infrastructure, including setting standards for AI used in the health care industry. The order seeks to…
HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness
In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long partnership between the Office of Inspector General (OIG) and…
CMS’ Making Care Primary (MCP) Model: Applications Due November 30, 2023
By Clara Greaney & James Miles
The Centers for Medicare and Medicaid Services’ (CMS) new program Making Care Primary (MCP), is anticipated to begin July 1, 2024.
In a previous blog post Foley breaks down major highlights of the new model.
On September 5, 2023,…
FDA: New Draft Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products
On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on its website. This guidance supersedes its 2014 draft guidance…
FDA Issues New Warning Regarding Compounded Ketamine
On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert regarding the potential risks associated with compounded…