BACKGROUND - As we noted in prior health care alerts in 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) significantly overhauled the federal law that governs the confidentiality of substance use...more
This final article in our four-part series examines other relevant laws digital health providers and suppliers should know. If you missed our earlier articles, you can read about HIPAA in Part I and Part II, and the FDCA and...more
In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors...more
10/7/2021
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Records ,
Mobile Health Apps ,
PHI ,
Policy Statement ,
Vendors
In this week’s episode, Gina Bertolini discusses two important aspects of the CMS Interoperability and Patient Access Final Rule that directly relate to health care providers, and how those aspects of the Final Rule will...more
12/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Participation (CoP) ,
Coronavirus/COVID-19 ,
Electronic Medical Records ,
Health Care Providers ,
Health Clinics ,
Health Information Technologies ,
Hospitals ,
Information Blocking Rules ,
Interim Final Rules (IFR) ,
Medical Records ,
Medicare ,
ONC ,
Patient Access ,
Reporting Requirements
In this week’s episode, Gina Bertolini, Lindsey Rogers-Seitz and Maggie Power discuss the Preventing Harm Exception to the Information Blocking Rule, which was recently finalized in the Office of the National Coordinator for...more
INTRODUCTION - The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) is responsible for the implementation of key provisions of Title IV of the 21st Century...more
The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), [1] signed into law March 27, 2020, significantly overhauls the federal law that governs the confidentiality of substance use disorder (“SUD”) records at...more
This week’s episode is the second in an ongoing series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the...more
10/17/2019
/ Confidential Information ,
Consent ,
Health Care Providers ,
Healthcare Facilities ,
Medical Records ,
Mental Health ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Pharmacies ,
Podcasts ,
Prescription Drugs ,
Proposed Rules ,
SAMHSA ,
Substance Abuse
This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of...more
10/8/2019
/ Confidential Information ,
Data Privacy ,
Data Use Policies ,
Electronic Medical Records ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Manufacturer Liability ,
Medical Records ,
Mental Health ,
Multidistrict Litigation ,
Municipalities ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Proposed Rules ,
Regulatory Agenda ,
SAMHSA ,
Substance Abuse
In the second episode of our series on the national opioid crisis, Gina Bertolini discusses the overlay of recent guidance concerning privacy laws such as the Health Insurance Portability and Accountability Act (HIPAA) and...more
3/1/2018
/ Confidential Information ,
Decision-Making Process ,
Department of Health and Human Services (HHS) ,
Diminished Capacity ,
Documentation ,
Drug & Alcohol Abuse ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Information Sharing ,
Medical Records ,
OCR ,
Opioid ,
PHI ,
Physician-Patient Confidentiality ,
Prior Authorization ,
SAMHSA ,
Substance Abuse ,
Trump Administration