On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more
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On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
7/16/2024
/ Clinical Trials ,
Comment Period ,
Diversity ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation
WHERE VALUE-BASED CARE MEETS THE BUSINESS OF HEALTHCARE -
Join hundreds of c-suite leaders, investors, operators and counsel in the healthcare capital of the United States for a deep dive into the key business and policy...more
5/6/2024
/ Best Practices ,
Business Development ,
Business Model ,
Business Opportunities ,
Continuing Legal Education ,
Data Privacy ,
Events ,
Exceptions ,
Health Care Providers ,
Health Plan Sponsors ,
Healthcare Costs ,
Innovation ,
Investment Opportunities ,
Investors ,
Joint Venture ,
Partnerships ,
PHI ,
Risk Adjustment Formula ,
Risk Management ,
Safe Harbors ,
Specialty Healthcare ,
Value-Based Care
The Physician Practice Management (PPM) and ASC Symposium 2024 is the destination event for PPM and ASC industry leaders and health industry investors. Join us as we deliver actionable insights on the state of the market and...more
5/3/2024
/ Ambulatory Surgery Centers ,
Artificial Intelligence ,
Business Development ,
Business Opportunities ,
Continuing Legal Education ,
Events ,
Exit Strategies ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Investment Banks ,
Investment Opportunities ,
Investors ,
Joint Venture ,
Medicare ,
Mental Health ,
Partnerships ,
Physicians ,
Prior Authorization ,
Privacy Laws ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Reimbursements ,
Risk Management ,
Substance Abuse ,
Telehealth ,
Value-Based Care
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more
YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING -
Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more
4/19/2024
/ Acquisitions ,
Biopharmaceutical ,
Biotechnology ,
C-Suite Executives ,
CEOs ,
Clinical Trials ,
Events ,
Health Care Providers ,
Health Technology ,
Innovation ,
Investment Banks ,
Investment Funds ,
Investment Opportunities ,
Investors ,
Med Tech ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Regulatory Requirements ,
Research and Development ,
Supply Chain ,
Venture Capital
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more
Hear from a global team on the crucial legal and regulatory topics investors need to know when buying or investing in Clinical Trial Site Management Organizations.
Investing in pharma services is complicated, but our team...more
On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials (Draft Guidance). It provides sponsors and others involved in clinical trial...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
Building on the success of our inaugural conference, McDermott’s Digital Health Forum is back! Join senior leaders transforming digital health for ample networking opportunities and robust panel discussions on the business,...more
4/4/2023
/ Best Practices ,
Business Development ,
Business Model ,
Business Operations ,
CEOs ,
Collaboration ,
Continuing Legal Education ,
Digital Health ,
Diversity ,
Events ,
Founding Members ,
Health Care Providers ,
Health Technology ,
Healthcare Facilities ,
Investors ,
Partnerships
The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support regulatory decision-making. Pharmaceutical...more
Precision health has the potential to dramatically transform the healthcare landscape by developing cutting-edge solutions that significantly improve patient outcomes. Now, following its contributions to the groundbreaking...more
As the COVID-19 pandemic in the United States is easing, telemedicine is facing an important crossroads. While telehealth services have demonstrated their value as an integral part of care delivery, federal and state waivers...more
6/14/2021
/ Advertising ,
Breach Notification Rule ,
Consumer Privacy Rights ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Covered Entities ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
Endorsements ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
PHI ,
Physicians ,
Social Media ,
Telehealth ,
Telemedicine ,
Webinars
In light of the COVID-19 pandemic, our 9th McDermott International Seminar Series will be held as a virtual series, with eight sessions taking place between January 21 – February 4, 2021. Though we cannot see you in person,...more
1/7/2021
/ Acquisitions ,
Biden Administration ,
Compliance ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Cybersecurity ,
Data Privacy ,
Enforcement Actions ,
FRAND ,
Global Market ,
Intellectual Property Protection ,
International Data Transfers ,
Investors ,
Japan ,
Mergers ,
Patent Portfolios ,
US Trade Policies ,
Webinars ,
White Collar Crimes
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
Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more
7/23/2020
/ Business Opportunities ,
Collaboration ,
Coronavirus/COVID-19 ,
Data Collection ,
Data Privacy ,
Digital Data ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Medical Research ,
Medical Technology Companies ,
Pharmaceutical Industry ,
Public Health ,
Real World Evidence ,
Research and Development ,
Webinars
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
The European Data Protection Supervisor, the independent European Union authority responsible for data protection regulatory oversight, issued a preliminary opinion on data protection and scientific research. The Opinion...more
1/24/2020
/ Advisory Opinions ,
Compliance ,
Consent ,
Data Protection ,
Data Protection Authority ,
Data Subjects Rights ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Member State ,
Personal Data ,
Scientific Research ,
The Common Rule ,
Transparency
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