Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
The use of artificial intelligence (AI) in research and development and the research and development of AI solutions themselves create far reaching legal and policy questions in the clinical research context.
In one of the latest installments of Reed Smith’s video series “AI explained”, Reed Smith attorneys Nancy Bonifant Halstead and Sarah Thompson Schick…
On October 20, 2015, the HHS Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP) is hosting a public town hall meeting to respond to questions related to its September 8, 2015 proposed rule that would modernize HHS regulations governing human research subjects under the Common Rule. The registration deadline for…
On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the Common Rule (45 C.F.R. Part 46). Under the current regulations, the Common Rule applies to all research involving human subjects that is conducted or supported by a federal department or agency that has adopted the policy. Subject to only specified exemptions, the proposed rule extends the Common Rule’s requirements to all clinical trials regardless of funding source if: (1) the clinical trial is not regulated by the FDA, and (2) is performed at a US institution that receives any support from a federal agency. Other major changes introduced in the proposed rule include:
Continue Reading Agencies Release Proposed Overhaul of the Common Rule
Congressional committees have held several hearings this week on health policy issues. On March 24, the Energy and Commerce Health Subcommittee held a hearing on the 340B drug pricing program. Also on March 24, the House Ways and Means Subcommittee on Oversight examined CMS’s use of the Fraud Prevention System (FPS) to identify and stop…
On October 24, 2014, the HHS Office for Human Research Protections published a notice announcing that it is seeking comments on draft guidance for the research community entitled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The guidance addresses risks to subjects that are presented by research evaluating risks…
Congressional panels have held numerous hearings on health policy issues this month, including the following:
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On June 10, 2014, the full House Energy and Commerce Committee approved by voice vote three bipartisan public health bills:
Continue Reading Full Energy and Commerce Committee Approves Three Bipartisan Health Bills
Yesterday, the U.S. Food and Drug Administration (FDA) made available data on millions of reports of drug adverse events and medication errors made to FDA between 2004 and 2013. The release of the data is part of FDA’s new data sharing initiative, openFDA, which is designed to make it easier for developers, researchers and…
On May 28, 2014 the House Energy and Commerce Subcommittee on Health approved by voice vote three bipartisan public health bills:
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On November 12, 2013, CMS announced the launch of its Virtual Research Data Center (VRDC), which is intended to provide researchers with more convenient, timely, and cost-effective access to secure CMS health care data without needing to request that the agency ship encrypted data files. According to CMS, traditional physical delivery of a large…
On September 10, 2013, HHS published a notice inviting comments on its Draft Departmental Strategic Plan for FY 2014–2018. The document details HHS strategies for achieving four strategic goals: (1) Strengthen Health Care, (2) Advance Scientific Knowledge and Innovation, (3) Advance the Health, Safety, and Well-Being of the American People, and (4) Ensure Efficiency, Transparency,…
On July 17, 2013, the House Energy and Commerce Committee approved H.R. 698, the HIV Organ Policy Equity Act. The legislation would eliminate the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals. The Senate approved its version of the bill, S. 330, on June 17, 2013.
The Department of Health and Human Services (HHS) is seeking input on how institutional review boards (IRBs) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects as part…
The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical, legal, and social issues raised by “incidental findings” (e.g., information obtained from testing that was not its intended or expected object) that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research,…
Beginning in July 2013, CMS will be posting downloadable data on from various Medicare.gov Compare websites (Dialysis Facility Compare, Home Health Compare, Hospital Compare, and Nursing Home Compare) at Data.Medicare.Gov. On May 16, 2013, CMS is hosting a webinar to provide an introduction to Data.Medicare.Gov and to demonstrate options for accessing the data. CMS…
CMS has unveiled its Medicare Chronic Conditions Dashboard – a tool designed to help researchers, health professionals, and policymakers find and analyze spending, demographic and other data regarding beneficiaries with multiple chronic conditions.
A number of recent Congressional hearings have focused on health policy issues, including the following:
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The Senate Health, Education, Labor and Pensions Committee held a field hearing in Connecticut on “Lyme Disease: A Comprehensive Approach to an Evolving Threat.” On September 11, 2012, the House Ways and Means Oversight Subcommittee is holding a hearing on the Internal Revenue Service’s implementation of various ACA tax provisions. Also on September 11,…
The Patient-Centered Outcomes Research Institute (PCORI) has announced a series of workshops intended to obtain input from patients, caregivers, and other stakeholders on PCORI’s draft process for generating and selecting specific research topics:
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On January 20, 2012, the Obama Administration posted its Fall 2011 Regulatory Agenda, outlining its planned regulatory initiatives in a number of policy areas. Priorities for the Department of Health and Human Services (HHS) include, among many others:
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