Healthcare

Biden Administration Seeks to Clarify Patient Privacy Protections Post-Dobbs, Though Questions Remain

On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]

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Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  For years, pharmacy advocates have urged policymakers to make changes to state scope of practice laws that would permit pharmacists to prescribe and administer certain tests and vaccines at the pharmacy. How has COVID-19 impacted these efforts?

Hear from special guest Will Chang, Chief Legal Officer of UpStream.

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Podcast: Owner’s Outlook: Renovating and Expanding Critical Access Hospitals in a Volatile Market – Diagnosing Health Care

From the Diagnosing Health Care Podcast:  Over the last 12–24 months, Critical Access Hospitals (CAHs) have seen steep cost escalation in their expansion and renovation plans, with expense increases exceeding 10 percent. Combined with nationwide staffing shortages, CAHs are at a crossroads as to how to proceed.

On this episode of our Owner’s Outlook series, hear from special guest Eric Shell, Chairman of Stroudwater Associates, a national advisory firm that designs solutions for rural and community hospitals.

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Unpacking Averages: Assessing Whether FDA’s Breakthrough Device Designation Is Helpful

You might be thinking, that’s an odd title: obviously FDA’s breakthrough device designation is helpful.  However, after looking at the data, my conclusion is that I would avoid the breakthrough device designation for any product that qualifies for the 510(k) process.  The process is likely not helpful for such devices.

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Healthcare Noncompete Laws Get a Checkup in Four States and the District of Columbia

As readers of this blog likely know, many states have entirely different statutory schemes for noncompetes in the healthcare industry. Indeed, while 47 states generally permit noncompetes, more than a dozen expressly prohibit or limit them in certain sectors of the healthcare industry – typically for patient-facing clinicians.

For example, in Massachusetts, noncompetes are not permissible in “[a]ny contract or agreement which creates or establishes the terms of a partnership, employment, or any other form of professional relationship with a physician registered to practice medicine . . . , which includes any restriction of the right of such physician to practice medicine in any geographic area for any period of time after the termination of such partnership, employment or professional relationship.” The same restriction applies to Massachusetts nurses, psychologists, and social workers.

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Podcast: Interoperability: Health Care’s Next Disruptor Is openEHR – Diagnosing Health Care

Featured on the Diagnosing Health Care Podcast:  How is openEHR transforming the way health data is managed and stored across Europe? Will it soon disrupt the U.S. marketplace?

In this episode of our special series on interoperability, hear from Alastair Allen, CTO of Better.

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OSHA issues emergency temporary standard applicable to healthcare providers

The U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”) has announced it will issue an emergency temporary standard (ETS) to protect healthcare workers from contracting coronavirus. Read more…

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Telemedicine Practice through Consultation Centres/Clinics in India: Guidelines and Regulatory Approvals

Onset of COVID 19 pandemic created an urgency in provision of medical services to remote areas through digital and online means and adoption of technology. Prior to March 25, 2020, there was no single consolidated regulation or guideline in India which dealt with the practice of telemedicine. Telemedicine was accordingly governed by the same statutes that govern the ‘practice of medicine’ in India such as Indian Medical Council Act, 1956 (as superseded by the National Medical Commission Act, 2019, the “IMC Act”) and the subsequent rules and regulations issued thereunder.

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In Response to COVID-19, FDA Extends Enforcement Discretion for HCT/Ps Requiring Pre-Market Review

On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the COVID-19 pandemic. Included in a final guidance document entitled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use,” this extension will give manufacturers additional time to determine whether they need to submit an investigational new drug (IND) or marketing application and to prepare and submit to FDA any required IND or marketing application before the enforcement discretion period expires on May 31, 2021. This extension should come as a welcome reprieve to manufacturers of affected products, many of which delayed seeking FDA approval of their products following release of the enforcement discretion policy guidance in November 2017.

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FDA to Resume Domestic Inspections with New Safety Measures after Temporary Pause Due to COVID-19 Health and Safety Concerns

On March 18, 2020, the United States Food and Drug Administration (FDA) announced the suspension of all domestic routine surveillance facility inspections until further notice. FDA took this measure to protect the health and well-being of its staff and those who conduct the inspections for the agency under contract at the state level, and due to industry concerns regarding visitors. During this interim period, the FDA conducted only a limited number of mission critical inspections using a risk-based approach. On July 10, 2020, FDA announced its plans to resume on-site inspections during the week of July 20th with the assistance of a newly developed COVID-19 Advisory Rating System for assessing the risk of carrying out an inspection in a particular location.

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