For AI companies in the health care space, data is everything. It fuels model performance, drives product differentiation, and can make or break scalability. Yet too often, data rights are vaguely defined or completely...more
6/26/2025
/ Artificial Intelligence ,
Contract Terms ,
Data Privacy ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Liability ,
Patient Privacy Rights ,
PHI ,
Regulatory Requirements ,
Risk Management
AI scribes are quickly becoming the digital sidekick of modern health care. They promise to reduce clinician burnout, streamline documentation, and improve the patient experience. But as health care providers and digital...more
6/10/2025
/ Artificial Intelligence ,
Compliance ,
Data Privacy ,
Data Security ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Machine Learning ,
PHI ,
Popular ,
Risk Management
Artificial intelligence (AI) is widely transforming digital health, including by automating certain patient communications. However, as health care companies consider deploying AI-driven chatbots, texting platforms, and...more
5/29/2025
/ Artificial Intelligence ,
ATDS ,
Automation Systems ,
Compliance ,
Consent ,
Digital Health ,
Facebook Inc v Duguid ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Regulatory Requirements ,
Risk Assessment ,
SCOTUS ,
TCPA
Artificial intelligence (AI) is rapidly reshaping the digital health sector, driving advances in patient engagement, diagnostics, and operational efficiency. However, for Privacy Officers, AI’s integration into digital health...more
5/9/2025
/ Artificial Intelligence ,
Bias ,
Compliance ,
Data Privacy ,
Data Security ,
Digital Health ,
Health Insurance Portability and Accountability Act (HIPAA) ,
PHI ,
Privacy Laws ,
Regulatory Requirements ,
Risk Management
The New York Health Information Privacy Act (NYHIPA), if enacted, could create a chilling effect on patient access and engagement to readily available digital health care services relied upon by New Yorkers. Digital health...more
1/24/2025
/ Compliance ,
Data Privacy ,
Digital Health ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Mental Health ,
New Legislation ,
New York ,
Patient Privacy Rights ,
Privacy Laws ,
Regulatory Requirements ,
State Privacy Laws
Material updates to the HIPAA Security Rule could be on the way — affecting all HIPAA-regulated entities — for the first time in two decades. The Department of Health and Human Services (HHS) issued a Notice of Proposed...more
1/7/2025
/ Cyber Threats ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Security Rule ,
Multi-Factor Authentication ,
NIST ,
Notice of Proposed Rulemaking (NOPR) ,
Policies and Procedures ,
Proposed Rules ,
Ransomware ,
Risk Management
The amendments to the HIPAA Privacy Rule designed to protect reproductive health care information (Amendments) are under legal challenge as the compliance date quickly approaches.
As discussed in more detail in our...more
12/20/2024
/ Administrative Procedure Act ,
Compliance ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Enforcement ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Medical Records ,
New Amendments ,
Privacy Laws ,
Reproductive Healthcare Issues ,
SCOTUS
Recognizing the increasing number of successful cyberattacks targeting health care organizations and their valuable patient data, the Office of the Inspector General (OIG) is calling for enhancements to the HIPAA audit...more
12/10/2024
/ Audits ,
Breach Notification Rule ,
Compliance ,
Cyber Attacks ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
Noncompliance ,
OCR ,
OIG ,
PHI ,
Vulnerability Assessments
Share on Twitter Print Share by Email Share Back to top HIPAA regulated entities may now begin implementing the amendments to the HIPAA Privacy Rule to provide additional protections for reproductive health care information...more
Pixels, cookies, and trackers continue to be front of mind for HIPAA regulated entities seeking clarity on their ability to advertise, market, and engage with existing and prospective patients. On March 18, 2024, the U.S....more
3/21/2024
/ Cybersecurity ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Innovative Technology ,
Privacy Laws ,
Tracking Systems ,
Web Tracking ,
Websites
Substance Use Disorder (SUD) programs and HIPAA-regulated entities seeking to streamline their privacy and security practices and workflows received welcome news from the U.S. Department of Health & Human Services (HHS) last...more
2/13/2024
/ Applicability Date ,
Breach Notification Rule ,
CARES Act ,
Consent ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Electronic Protected Health Information (ePHI) ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Notice of Proposed Rulemaking (NOPR) ,
Patient Rights ,
Penalties ,
PHI ,
Substance Abuse
Recognizing the evolving landscape of care delivery and growth of telehealth, the U.S. Department of Health and Human Services (HHS) published a resource guide aimed at assisting telehealth providers in explaining the privacy...more
If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create a transformative...more
9/15/2023
/ Artificial Intelligence ,
Change of Control ,
Collaboration ,
Contract Term ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Healthcare ,
Hospitals ,
License Renewals ,
Medical Devices ,
Pharmaceutical Industry ,
Pricing ,
Regulatory Requirements ,
Startups
Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will...more
3/30/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare Administrative Contractors (MAC) ,
Opioid ,
PHI ,
Public Health Emergency ,
Substance Abuse ,
Telemedicine
Proposed changes to the federal substance use disorder law will increase provider efficiency and alignment with the Health Insurance Portability and Accountability Act (HIPAA). In a move that seeks to decrease administrative...more
Preparation for operations after the end of the Public Health Emergency (PHE) have commenced. HHS released guidance on using remote communication technologies for audio-only telehealth services in compliance with HIPAA. In...more
Preparation for operations after the end of the Public Health Emergency (PHE) have commenced. HHS released guidance on using remote communication technologies for audio-only telehealth services in compliance with HIPAA. In...more
The Federal Trade Commission (FTC) just released a Policy Statement emphasizing how telemedicine and digital health apps can be held accountable under the Health Breach Notification Rule, even if the company is not subject to...more
What does the new Supreme Court text message ruling mean for your digital health business?
The Supreme Court ruled in favor of Facebook, holding that the Telephone Consumer Protection Act (TCPA) did not apply to Facebook...more
4/6/2021
/ ATDS ,
Auto-Dialed Calls ,
Facebook ,
Facebook Inc v Duguid ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Random or Sequential Number Generator ,
Robocalling ,
SCOTUS ,
TCPA ,
Telemedicine
Throughout the COVID-19 pandemic, federal agencies have sought to allow health care companies more flexibility to use popular technology and applications to better engage with their patients. One example is the Department of...more
Telemedicine and remote patient monitoring companies often want to maintain open communication channels with patients, whether it be scheduling, medication reminders, engagement pings, or even new product and service updates....more
3/8/2021
/ Class Action ,
Enforcement Actions ,
FCC ,
Federal Trade Commission (FTC) ,
Fines ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Notifications ,
Statutory Damages ,
TCPA ,
Telemedicine ,
Texting ,
Written Consent
On January 14, 2021, the U.S. Court of Appeals for the Fifth Circuit vacated the civil monetary penalty (CMP) imposed by the Department of Health and Human Services (HHS) against the University of Texas M.D. Anderson Cancer...more
On January 19, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a Notice of Enforcement Discretion (Notice) announcing that it will not impose penalties for...more
1/26/2021
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Encryption ,
Enforcement ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Privacy Settings ,
Public Health Emergency ,
Vaccinations
The Office of Civil Rights (OCR) at the U.S. Department of Health and Human Services recently published its findings from audits conducted in 2016 and 2017 of covered entities’ and business associates’ compliance with...more
1/15/2021
/ Audits ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach Notification Rule ,
HIPAA Privacy Rule ,
Notice of Privacy Practices ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Right of Access ,
Risk Management ,
Security Risk Assessments
With 2020 officially behind us, what does 2021 have in store for telemedicine and digital health policy? A year ago, our team predicted 2020 would bring “notable expansions in Medicare and Medicaid coverage” and “the...more
1/12/2021
/ American Telemedicine Association ,
California Consumer Privacy Act (CCPA) ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medicare ,
OIG ,
Public Health Emergency ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Reimbursements ,
Telehealth ,
Waivers