On October 11, the National Institutes of Health (“NIH”) issued a request for information (“RFI”), which proposes sample language regarding the use of digital health technologies in research for inclusion in informed consent documents and requests public feedback on the utility and usability of the proposed language. Comments on the RFI are due by December 12, 2023.
Continue Reading NIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies
Crowell & Moring
OCR Issues Guidance to Providers and Patients on Telehealth Privacy and Security
Last week, the Office for Civil Rights (“OCR”) issued two pieces of guidance on the privacy and security of protected health information (“PHI”) when using telehealth services. One of the documents is intended to help health care providers explain to patients, in plain language, the privacy and security risks of using remote communication technologies for telehealth (the “Provider Telehealth Guidance”). The other provides tips to patients on how to safeguard their PHI when using video apps and other technologies for telehealth (the “Patient Telehealth Guidance”).
Continue Reading OCR Issues Guidance to Providers and Patients on Telehealth Privacy and SecuritySenate HELP Committee Ranking Member Requests Stakeholder Feedback on AI and Health Data Privacy and Security Policies
Last week, Ranking Member Bill Cassidy (R-LA) of the Senate Committee on Health, Education, Labor and Pensions (“HELP”) issued two separate requests for information (“RFIs”) asking for stakeholder feedback on artificial intelligence (“AI”) and health data privacy policy issues to identify current challenges and receive recommendations to inform potential legislation. With deadlines set for the end of September, each RFI provides a short window for organizations to submit comments.
Continue Reading Senate HELP Committee Ranking Member Requests Stakeholder Feedback on AI and Health Data Privacy and Security PoliciesHHS-OIG Releases Final Rule Implementing Information Blocking Penalties
On June 27, 2023, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“OIG Final Rule”) that implements statutory provisions for its enforcement of the information blocking penalties created by the 21stCentury Cures Act (“Cures Act”) and assessment of civil money penalties (“CMPs”) of up to $1 million per violation of information blocking for certain individuals or entities subject to the information blocking requirements.
Continue Reading HHS-OIG Releases Final Rule Implementing Information Blocking PenaltiesCMS Innovation Center Reports Data Challenges in Assessing Health Equity
On July 10, 2023, the Center for Medicare & Medicaid Innovation (CMMI or “Innovation Center”) released a White Paper, Assessing Equity to Drive Health Care Improvements, outlining their analysis and assessment of health equity incorporation in model designs and evaluations. CMMI supports the development and testing of innovative health care payment and service delivery models. These innovation models are designed to improve quality of care and patient outcomes while reducing or maintaining program costs.[1]
Continue Reading CMS Innovation Center Reports Data Challenges in Assessing Health EquityExamining the Use of the Area Deprivation Index in Value-Based Care Models
The Centers for Medicare & Medicaid Services (CMS) has recognized that addressing health care disparities and achieving health equity should drive our nation’s top health priorities.[1] According to the CMS Framework for Health Equity 2022-2023, health equity is defined as, “the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes”. In order to eliminate health and health care disparities, there needs to be an effort to provide quality, equitable care to those in areas without access and availability to the services necessary to meet their health and social needs.
Continue Reading Examining the Use of the Area Deprivation Index in Value-Based Care ModelsFDA Decentralized Clinical Trials Draft Guidance
On May 2, FDA published a draft guidance on decentralized clinical trials (DCTs) to provide recommendations for sponsors, investigators and others on implementation of DCTs, as required by the Food and Drug Omnibus Reform Act (FDORA).
Background
DCTs include both fully decentralized trials – where all trial activities take place at locations other than trial…
Food is Medicine: Can Policymakers Come to the Table?
In 2021, 1 in 10 American households experienced food insecurity, an issue exacerbated by the COVID-19 pandemic.[1] Diet-related diseases such as diabetes, heart disease, and cancer are some of the leading causes of death and disability in the U.S. Each year in the U.S. there is an estimated $52.8 billion in excess health care costs as a result of adults experiencing food insecurity.[2] Since recognizing the influence of nonmedical factors such as socioeconomic status, education, and physical education on health, there have been a growing number of initiatives to address social determinants of health (SDOH) within the health care system. Food is medicine interventions are tailored to respond to the connection between food and health in order to help prevent, manage, or reverse diet-related disease.[3] Food is medicine interventions may include medically tailored meals, produce prescriptions, and medically tailored food packages. These interventions have been associated with decreased inpatient hospital admissions, decreased overall healthcare costs, increased medication adherence, and increased diet quality.[4] The concept of using healthy foods to reduce diet-related disease in the U.S. is increasing in popularity. There is bipartisan support for food is medicine initiatives to target food insecure and medically vulnerable populations.
Continue Reading Food is Medicine: Can Policymakers Come to the Table?Clinicians Request Continued Medicare Coverage of Remote Patient Monitoring Services at Contractor Advisory Committee Meeting
On February 28, Medicare Administrative Contractors (MACs) contractors—Novitas Solutions (Jurisdictions H and L), First Coast Service Options (Jurisdiction N), Noridian Healthcare Solutions (Jurisdictions E and F), CGS Administrators (Jurisdiction 15), Palmetto GBA (Jurisdictions J and M), and WPS Government Health Administrators (Jurisdictions 5 and 8)—held a multi-jurisdictional Contractor Advisory Committee (CAC) meeting to obtain feedback…
CHS Turns One & Unveils Trends in Transformations Blog
Crowell Health Solutions turns one and to celebrate is launching its own blog, Trends in Transformation. Below CHS recaps what the team accomplished in its first year and what the consultancy looks forward to achieving in 2023.
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