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The FTC is closing out 2022 with additional guidance for mobile health app developers signaling its continued interest in this industry. Since 2021, we have seen several steps from the agency demonstrating a focus on companies that collect health information but may not be a covered entity or business associate under HIPAA. This includes publishing additional resources, releasing commentary broadly interpreting the FTC’s Health Breach Notification Rule, and enforcement activity. Most recently, the FTC and other key regulators updated its “Mobile Health App Interactive Tool”.…

Continue Reading FTC and Other Regulators Continue to Signal Interest in Mobile Health Apps

The State Attorneys General in New York and New Jersey recently settled with four companies over alleged HIPAA noncompliance following phishing attacks. The New Jersey settlements were brought against three NJ-based cancer care providers after a phishing attack on several employees’ email accounts. That attack resulted in the unauthorized access of the PHI of 105,200 patients. Although the providers had implemented safeguards, the NJAG concluded that those measures were insufficient to protect against reasonably anticipated threats. In particular, the NJAG was concerned that an accurate and thorough risk assessment had not been conducted, nor was there sufficient employee training. As part of the settlement, the providers agreed to pay $425,000.
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Continue Reading States Catch Health Care Entities Taking the Bait in Phishing Attacks

The digital health sector has been rapidly growing, and the demand is not expected to diminish. Those in the industry will want to keep in mind some key legal concerns in the coming year, which we outline in this recent article. Privacy and cybersecurity features among these, and include more than just HIPAA concerns. There is an ever-growing patchwork of state and federal privacy laws that are being applied to the industry. At the same time, cyber threat actors are finding ways to attack even the most prepared companies in the digital health space.
Continue Reading Digital Health Trends and Privacy: What to Watch in 2022

California recently updated both its data security and breach notice laws to include genetic data. With the passage of AB 825, the data security law now includes in the definition of “personal information” genetic data. The information needs to be “reasonably protected.” While many other states have similar “reasonable protection” requirements in their data security laws, California is one of a handful to specifically list genetic information.
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Continue Reading California Broadens Security and Breach Laws, Includes Genetic Data

Recently, the National Institute of Standards and Technology (NIST) requested comments to its Resource Guide for implementing the HIPAA Security Rule. (i.e., SP 800-66). This Guide, first released in 2008, summarizes the HIPAA Security Rule standards and explains the structure and organization of the Security Rule.
Continue Reading NIST Plans to Update HIPAA Security Guidance – Asks for Comments

On May 6, 2019, the U.S. Department of Health and Human Services announced that Touchstone Medical Imaging will pay $3 million to settle potential HIPAA violations associated with a breach that exposed more than 300,000 patients’ Protected Health Information. The breach occurred in May 2014. One of Touchstone’s servers allowed uncontrolled access to patients’ PHI. As a result, Touchstone patients’ PHI was visible on the Internet. During its investigation, HHS determined that Touchstone did not thoroughly investigate the breach until several months after it was informed of the breach by law enforcement. HHS also found that the company did not conduct an accurate analysis of potential risks to the confidentiality of its PHI and did not have business associate agreements in place with its vendors.
Continue Reading HHS Announces First HIPAA Breach Settlement of 2019; 300,000 Patients Affected