During this session, the panelists discussed the role that SMOs and dedicated clinical trial sites (Site Platforms) play within the life sciences industry, what makes them attractive to investors, and the key criteria...more
On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more
11/1/2023
/ Artificial Intelligence ,
Biden Administration ,
Data Security ,
Executive Orders ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Legislative Agendas ,
New Legislation ,
New Regulations ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology
Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective...more
During this session, leaders from Covera Health and Nuance Communications provided insights into their companies’ collaboration to improve patient outcomes and operational efficiency through innovative technology solutions....more
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more
On April 12, 2023, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking detailing its proposal to modify the HIPAA Privacy Rule (Proposed Rule). The...more
On December 10, 2020, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) with proposed modifications to the Standards for the Privacy of...more
12/18/2020
/ Department of Health and Human Services (HHS) ,
Disclosure ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Access Request ,
HIPAA Privacy Rule ,
Information Requests ,
Medicare ,
NPRM ,
OCR ,
Third-Party
There are myriad opportunities for hospitals and health systems (HHSs) to engage in data-focused collaborations with other stakeholders in the healthcare industry. These collaborations include, to an increasing extent,...more
10/4/2019
/ Data Breach ,
Data Collection ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Investors ,
Joint Venture ,
Patient Privacy Rights ,
Personally Identifiable Information ,
Private Equity ,
Risk Assessment
In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more
On January 22, 2014, the FDA issued finalized guidance on the use, content and form of Dear Health Care Provider (DHCP) letters. While the finalized guidance modifies and removes certain controversial provisions from the...more