During this session, leaders from health systems and digital health technology companies explored how they are leveraging their prowess to develop cutting-edge strategies to deliver accessible, easy to use and secure digital...more
Through the groundbreaking creation and rapid development of cutting-edge diagnostic and treatments solutions that significantly improve patient outcomes for cancer and other conditions, precision medicine has, and will...more
7/19/2021
/ Collaboration ,
Data Privacy ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Partnerships ,
Physicians ,
Precision Medicine Initiative (PMI) ,
Regulatory Requirements ,
Reimbursements ,
Webinars
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
7/7/2021
/ Business Opportunities ,
Business Strategies ,
Collaboration ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Reform ,
Precision Medicine Initiative (PMI) ,
Privacy Laws ,
Regulatory Requirements ,
Reimbursements ,
Research and Development ,
Risk Management ,
Strategic Planning ,
Webinars
Hospital and Health System Innovation Centers clear the path for healthcare advancement. And in an environment upended by COVID-19, there is no better time for investment in innovation and growth of collaborative partnerships...more
11/3/2020
/ Business Development ,
Business Strategies ,
C-Suite Executives ,
Collaboration ,
Conflicts of Interest ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
De-Identified Protected Health Information ,
Due Diligence ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Innovation ,
Investment Management ,
Investment Opportunities ,
Investors ,
Partnerships ,
Physicians ,
Webinars
Digital health companies are producing increasingly innovative products at a rapidly accelerating pace, fueled in large part by the expansive healthcare data ecosystem and the data strategies for harnessing the power of that...more
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
On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more
1/20/2020
/ 21st Century Cures Act ,
Artificial Intelligence ,
Big Data ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Machine Learning ,
Medical Devices ,
OMB ,
Policy Memorandums ,
Regulatory Agenda ,
Technology ,
Telehealth
On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more
1/16/2020
/ 21st Century Cures Act ,
Artificial Intelligence ,
Big Data ,
Data Privacy ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Medical Devices ,
OMB ,
Policy Memorandums ,
Public Agencies ,
Public Interest ,
Regulatory Agencies ,
Regulatory Agenda ,
Risk Assessment ,
Risk Management ,
Technology ,
Telehealth ,
White Papers
As the health industry evolves to meet consumer expectations for better quality, lower-cost and more convenient health care options, the demand for technology-driven innovation is accelerating as is the level of interest and...more
Fortune’s April 2018 cover story, “Tech’s Next Big Wave: Big Data Meets Biology,” conveys loudly and clearly that technological innovation is transforming the health care continuum—changing the way care is delivered, as well...more
The General Data Protection Regulation establishes protections for the privacy and security of personal data about individuals in the European Economic Area countries, and potentially affects the medical tourism programs and...more
The General Data Protection Regulation (GDPR) establishes protections for the privacy and security of personal data (Personal Data) about individuals in the European Union (EU) single market countries, and potentially affects...more
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more
2/7/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Human Rights ,
Informed Consent ,
IRB ,
Medical Devices ,
Medical Research ,
NPRM ,
Proposed Regulation ,
Scientific Research ,
The Common Rule
Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held...more
Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the...more
INTRODUCTION -
Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the...more
In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more
9/9/2015
/ Clinical Trials ,
Comment Period ,
Data Security ,
Department of Health and Human Services (HHS) ,
Exemptions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Human Genome Project ,
Informed Consent ,
IRB ,
Jurisdiction ,
Medical Research ,
NPRM ,
Proposed Regulation ,
Recordkeeping Requirements ,
Scientific Research ,
The Common Rule
Health care general counsel should review, and brief their internal clients on, the new Practical Guidance for Health Care Governing Boards on Compliance Oversight (Guidance), released on April 20, 2015. A joint effort by...more
On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule (Final Rule) containing modifications to the privacy standards (Privacy Rule), security...more
2/21/2013
/ Business Associates ,
Covered Entities ,
Data Breach ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Enforcement ,
GINA ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Notice Requirements ,
OCR ,
PHI ,
Privacy Rule