Digital Health Industry Take Note: New HIPAA Comment Opportunity and Guidance Addresses Growing Risk of Cybersecurity Attacks
Digital health companies should take note of new data privacy and security developments under the Health Insurance Portability and Accountability Act (HIPAA) that can affect product planning and customer negotiations.
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has released a request for information (RFI) … Read More
Digital Health Compliance Considerations — Revenue Models and Patient Incentives
Digital Health Compliance Considerations — Revenue Models and Patient Incentives
The digital health market continues to grow exponentially in the United States. As startups and established companies market digital tools and technology to improve health outcomes and reduce costs, a key issue is whether the revenue model and any incentives … Read More
HHS Issues Proposed Rule Modernizing HIPAA Privacy Rule
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule (the Proposed Rule) that would make a number of key changes to the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 and the Health … Read More
OCR 2020 Settlements Target HIPAA Security Rule Non-Compliance
In almost the first three quarters of 2020, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) has settled three cases related to alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”), totaling $1,165,000. These settlements underscore OCR’s continued focus on enforcement of the … Read More
OCR Reduces HIPAA Penalties and Clarifies Liability for Transferring ePHI to Third-Party Health Apps
New Annual HIPAA Penalty Tiers
Six months after imposing the largest ever HIPAA fine ($16 million) following a HIPAA data breach, the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) has announced that it is exercising its enforcement discretion to lower maximum annual HIPAA penalties.
HHS Releases Cybersecurity Guidance for Healthcare Organizations
On December 28, 2018, the U.S. Department of Health and Human Services (HHS) released a four-volume cybersecurity guidance document for healthcare organizations. The publication, “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP), is the result of a government and industry collaboration mandated by the Cybersecurity Act … Read More
HHS Requests Feedback on HIPAA Changes Designed to Improve Care Coordination
On December 14, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published in the Federal Register a request for information (RFI) titled “Modifying HIPAA Rules to Improve Coordinated Care.” The RFI seeks public input on a broad range of potential reforms to Health … Read More
Proposed Changes to Federal Health Privacy Regulations Now at OMB for Review
The Administration is preparing to release a Request for Information (“RFI”) on potential modifications to Health Insurance Portability and Accountability Act (HIPAA) rules. The draft RFI was recently submitted by the Department of Health and Human Services (“HHS”) to the White House’s Office of Management and Budget (“OMB”) for pre-release … Read More
HHS Secretary Azar Signals Future Changes to Federal Health Privacy Regulations
In a recent speech outlining the Trump Administration’s healthcare regulatory reform efforts, Secretary of Health and Human Services (HHS) Alex Azar announced that the Administration will soon begin considering changes to federal health privacy regulations.
Advocate Health to Pay Largest Ever HIPAA Settlement; HHS Flags Failure to Conduct Comprehensive, Organization-wide Risk Assessment
On Thursday, August 4, 2016, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that Advocate Health Care Center (Advocate Health) agreed to pay $5.55 million to settle multiple violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This is the … Read More