In a new post on the Covington Digital Health blog, our colleagues discuss recently issued proposed rule to implement statutory amendments enacted by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).  Specifically, the proposed rule would harmonize certain provisions of the Confidentiality of Substance Use Disorder Patient Records under

On September 15, the Federal Trade Commission (“FTC”) adopted, on a 3-2 party-line vote, a policy statement that takes a broad view of which health apps and connected devices are subject to the FTC’s Health Breach Notification Rule (the “Rule”) and what triggers the Rule’s notification requirement.

The Rule was promulgated in 2009 under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act.  Under the Rule, vendors of personal health records that are not otherwise regulated under the Health Insurance Portability and Accountability Act (“HIPAA”) are required to notify individuals, the FTC, and, in some cases, the media following a breach involving unsecured identifiable health information.  Third-party service providers also are required to notify covered vendors of any breach.
Continue Reading FTC Adopts Policy Statement on Privacy Breaches by Health Apps and Connected Devices

To add to the growing list of federal privacy frameworks introduced this year, Senator Amy Klobuchar (D-MN) has re-introduced the bipartisan Social Media Privacy Protection and Consumer Rights Act of 2021 (S. 1667).  Senator Klobuchar introduced the bill originally in 2018 and 2019, although it did not advance to committee in either instance.  Senators Kennedy (R-LA), Burr (R-NC), and Manchin (D-WV) have co-sponsored the bill.

Key provisions in this bill include:
Continue Reading New Privacy Bill Provides Opt-Out Rights and New Data Security Requirements

On April 30, 2019, the Department of Health and Human Services (HHS) published in the Federal Register a notification of enforcement discretion indicating that it will lower the annual Civil Money Penalty (CMP) limits for three of the four penalty tiers in the Health Information Technology for Economic and Clinical Health Act (HITECH Act).  The HITECH Act categorizes violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in four tiers based on the violators’ level of culpability for the violation: the person did not know (and, by exercising reasonable diligence, would not have known) that the person violated the provision (Tier 1); the violation was due to reasonable cause, and not willful neglect (Tier 2); the violation was due to willful neglect that is timely corrected (Tier 3); and the violation was due to willful neglect that is not timely corrected (Tier 4).

The maximum penalty per violation for all four tiers was previously $1.5 million.  HHS’s new policy states that the annual penalty limit for Tier 1 violations has now been decreased from $1.5 million to $25,000.  The new annual penalty limits for Tier 2 and 3 violations are now $100,000 and $250,000, respectively.  The penalty limit for Tier 4 violations will remain at $1.5 million.
Continue Reading HHS Updates Maximum Annual Penalty Limits for Some HIPAA Violations

On April 19, 2019, the Department of Health and Human Services (HHS) announced a 30-day extension, until June 3, 2019, to the comment period for two rules proposed by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC).

The CMS proposed rule aims to

On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an app’s impermissible use or disclosure

The beginning of 2017 has brought a number of HIPAA enforcement actions involving covered entities. These enforcement actions indicate that HHS is continuing recent efforts to step up HIPAA enforcement and levy significant penalties for non-compliance.

  • In January, HHS announced that it had reached a $475,000 settlement with a large health care network for failure to make timely required breach notifications as required by the HIPAA Breach Notification Rule. This is the first settlement HHS has reached based on the untimely reporting or notification of a breach. HHS found that the network failed to notify HHS, the affected individuals, and the media within the required 60-day timeframe. Instead, the network made these notifications over 100 days after discovery of the breach. HHS found that the delay was a result of “miscommunications between . . . workforce members.” Under the regulation, each day on which the network failed to make the required notifications could be penalized as a separate violation of HIPAA.
  • In January, HHS announced a $2.2 million settlement with a health insurance company after the company filed a breach report indicating that a portable USB device, which contained the PHI of over 2,000 individuals, had been stolen. An HHS investigation found that the company had not conducted a risk analysis, as required by the HIPAA Security Rule, and had not implemented appropriate risk management to safeguard electronic PHI. Furthermore, the company lacked adequate encryption on its laptops and removable storage media.


Continue Reading HHS Announces More HIPAA Enforcement Actions

The FTC has become the most recent regulator to take a closer look at ransomware and its impact on consumers. During the FTC’s September 7, 2016, Fall Technology Series on Ransomware, Chairwoman Edith Ramirez announced that the FTC will soon release guidance to businesses on how to protect against ransomware.

Ransomware is a malicious software