On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more
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Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more
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
As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to...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
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