Against the backdrop of the National Cybersecurity Strategy’s stated goal of harmonizing federal cyber incident reporting requirements, new requirements still continue to emerge. Among the latest is a Federal Trade Commission...more
This week the U.S. Department of Health and Human Services, the agency responsible for HIPAA enforcement, announced the formation of three new divisions within the Office for Civil Rights (“OCR”). The new divisions –...more
The U.S. Federal Communications Commission (FCC or Commission) released a Notice of Proposed Rulemaking (NPRM) seeking to update and strengthen its rules requiring telecommunications carriers and interconnected Voice over...more
The Cybersecurity and Infrastructure Security Agency (CISA) has issued a Request for Information (RFI) and announced “public listening sessions” soliciting input in advance of formal rulemaking under the Cyber Incident...more
9/13/2022
/ Critical Infrastructure Sectors ,
Cyber Attacks ,
Cyber Incident Reporting ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Ransomware ,
Rulemaking Process
The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more
The Federal Trade Commission (FTC) recently has signaled its intent to inject new life into a longstanding but rarely triggered rule governing health breach notifications for non-HIPAA-covered health records. Specifically,...more
2/28/2022
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Digital Health ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Popular
Connecticut’s new cybersecurity standards law, which goes into effect on October 1, 2021, protects companies from punitive damages in certain data breach actions where an organization has a cybersecurity program that conforms...more
10/1/2021
/ Affirmative Defenses ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Federal Information Security Modernization Act (FISMA) ,
Gramm-Leach-Blilely Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
NIST ,
Popular ,
Safe Harbors ,
State Data Breach Notification Statutes
On April 27, 2021, the New York State Department of Financial Services (“DFS” or the “Department”) released a report regarding its investigation into the response by DFS covered entities to the SolarWinds supply chain attack....more
5/5/2021
/ Cyber Attacks ,
Cyber Crimes ,
Cybersecurity ,
Data Breach ,
Hackers ,
Incident Response Plans ,
Information Technology ,
NYDFS ,
Russia ,
Software ,
SolarWinds ,
Supply Chain ,
Third-Party Service Provider
Ransomware victims face a nearly impossible decision: pay criminals holding their business hostage or refuse and face possible crippling consequences. This decision requires careful analysis of a number of considerations, and...more
2/25/2021
/ Cyber Attacks ,
Cyber Crimes ,
Cybersecurity ,
Data Breach ,
Hackers ,
Incident Response Plans ,
Information Technology ,
New Guidance ,
NYDFS ,
Personally Identifiable Information ,
Popular ,
Ransomware
On February 4, the New York Department of Financial Services (NYDFS) released Insurance Circular Letter No. 2 (2021), a Cyber Insurance Risk Framework (Framework) for insurers that write cyber insurance....more
2/17/2021
/ Consumer Insurance Products ,
Cyber Attacks ,
Cyber Crimes ,
Cyber Insurance ,
Cybersecurity ,
Cybersecurity Framework ,
Data Breach ,
Data Protection ,
Insurance Regulations ,
NYDFS ,
Popular ,
Risk Management ,
State and Local Government
There has been a significant development in the ongoing debate regarding the scope of the authority of the Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) to issue penalties under the Health...more
There has been a significant development in the ongoing debate regarding the scope of the authority of the Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) to issue penalties under the Health...more
Following promises of increased enforcement, on July 22, 2020, the New York Department of Financial Services (NYDFS) announced the first cybersecurity enforcement action pursuant to its Cybersecurity Regulation, which...more
Last week, the U.S. District Court for the Eastern District of Virginia ordered Capital One to produce a forensic investigation report in multidistrict litigation arising out of the cyber incident Capital One announced in...more
Last week, the U.S. District Court for the Eastern District of Virginia ordered Capital One to produce a forensic investigation report in multidistrict litigation arising out of the cyber incident Capital One announced in...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
Regulators, industry experts, and researchers provided insight into health privacy and security enforcement trends, emerging threats, and new tools at a recent conference focused on the Health Insurance Portability and...more
10/22/2019
/ Cyber Attacks ,
Cybersecurity ,
Cybersecurity Framework ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Information Technology ,
NIST ,
OCR ,
Personally Identifiable Information ,
PHI ,
Right of Access ,
Risk Assessment
On July 25, New York Governor Andrew Cuomo signed into law a pair of bills establishing new requirements for businesses that process certain personal information related to New York residents. The changes include expanding...more
8/8/2019
/ Biometric Information ,
Cybersecurity ,
Data Breach ,
Data Protection ,
Data Security ,
Governor Cuomo ,
Hackers ,
New Legislation ,
Personally Identifiable Information ,
Popular ,
Security Standards ,
SHIELD Act ,
State and Local Government ,
State Data Breach Notification Statutes
In a dramatic turn, the US Department of Health and Human Services (HHS) has announced that effective immediately, penalties for many HIPAA violations will be subject to substantially reduced limits. ...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan)...more
4/26/2018
/ Connected Items ,
Cybersecurity ,
Data Breach ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Patient Safety ,
Personal Data ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Risk Management
Prompted by concern over the increase in the risks and frequency of data breach incidents and other cyber-attacks affecting public companies, the Securities and Exchange Commission recently published interpretive guidance to...more
3/6/2018
/ Cyber Threats ,
Cybersecurity ,
Data Breach ,
Disclosure Requirements ,
Financial Statements ,
Insider Trading ,
Interpretive Rule ,
Non-Public Information ,
Publicly-Traded Companies ,
Regulation FD ,
Regulation S-K ,
Risk Management ,
Securities and Exchange Commission (SEC)
In the past month, the National Institute of Standards and Technology (NIST) has issued a draft update to its flagship cybersecurity framework as well as new standalone guidance on how organizations can plan to recover from...more
1/26/2017
/ Comment Period ,
Critical Infrastructure Sectors ,
Cyber Attacks ,
Cybersecurity ,
Cybersecurity Framework ,
Data Breach ,
Data Protection ,
NIST ,
Ransomware ,
Risk Management ,
Supply Chain