The Health Insurance Portability and Accountability Act of 1996 may be the most well-known privacy law in the United States, but it is also one of the most misunderstood.

Many

Continue Reading HIPAA Covers a Lot Less Than People Think. But Beware of Other US Privacy Laws.

Hey hospitals, retirement homes and clinics! If you are using biometrics to control medication dispensing systems, then Illinois’ Biometric Information Privacy Act then (BIPA) has news for you.

The use
Continue Reading Illinois’ Biometric Information Privacy Act Is Coming for Hospitals, Long-Term Care Providers

On the sixth day of CCPA the California Senate Health Committee gave to me … a HIPAA carve-out.

AB 713, reported favorably by the California Senate Health Committee, would expand
Continue Reading CA Senate Proposes Expanded CCPA Carve-Outs Related to HIPAA, Biomedical Research

A study shows that “92 percent of 36 mental health apps shared data with at least one third party — mostly services that help with marketing, advertising, or data analytics.”
Continue Reading Mental Health Apps Sharing Health Data Without Disclosure or Consent

Last week we posted about A Brief Primer on the NIST Cybersecurity Framework. Our partner and HIPAA/HITECH expert Elizabeth Litten took the NIST Cybersecurity Framework and created a blog post for the HIPAA, HITECH and Health Information Technology Blog on how How the NIST Cybersecurity Framework Can Help With HIPAA Compliance: 3 Tips. For those facing any HIPAA-related issues, it is a worthwhile read.
Continue Reading How the NIST Cybersecurity Framework Can Help With HIPAA Compliance: 3 Tips

I strongly urge every covered entity and business associate faced with a Business Associate Agreement that includes indemnification provisions to read Michael Kline’s “List of Considerations” before signing.  Michael’s list,
Continue Reading Michael Kline’s “List of Considerations” for Indemnification Provisions in Business Associate Agreements

As if compliance with the various federal privacy and data security standards weren’t complicated enough, we may see state courts begin to import these standards into determinations of privacy actions
Continue Reading HIPAA Does Not Preempt State Privacy Cause of Action But May Represent “Standard of Care”, Says Connecticut Supreme Court

Innovative health care-related technology and developing telemedicine products have the potential for dramatically changing the way in which health care is accessed. The Federation of State Medical Boards (FSMB) grappled with some of the complexities that arise as information is communicated electronically in connection with the provision of medical care and issued a Model Policy in April of 2014 to guide state medical boards in deciding how to regulate the practice of “telemedicine”, a definition likely to become outdated as quickly as the next technology or product is developed.

Interestingly, the development and use of medical devices and communication technology seems to outpace agency definitions and privacy laws as quickly as hackers outpace security controls. So how can we encourage innovation and adopt new models without throwing privacy out with the bathwater of the traditional, in-person patient-physician relationship? A first step is to see and understand the gaps in privacy protection and figure out how to they can be narrowed.

HIPAA does not protect all information, even when the information is clearly health information and a specific individual can be identified in connection with the health information. A guidance document issued jointly by the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) on October 2, 2014 (FDA Guidance Document) contains the agencies’ “non-binding recommendations” to assist the medical device industry with cybersecurity. The FDA Guidance Document defines “cybersecurity” as “the process of preventing unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.” If my medical device creates, receives, maintains, or transmits information related to my health status or condition, it’s likely I expect that information to be secure and private – but unless and until my doctor (or other covered entity or business associate) interfaces with it, it’s not protected health information (PHI) under HIPAA.

The FSMB’s Model Policy appropriately focused on the establishment of the physician-patient relationship. In general, HIPAA protects information created, received, maintained or transmitted in connection with that relationship. A medical device manufacturer, electronic health application developer, or personal health record vendor that is not a “health care provider” or other covered entity as defined under HIPAA, and is not providing services on behalf of a covered entity as a business associate, can collect or use health-related information from an individual without abiding by HIPAA’s privacy and security obligations. The device, health app, or health record may still be of great value to the individual, but the individual should recognize that the information it creates, receives, maintains or transmits is not HIPAA-protected until comes from or ends up with a HIPAA covered entity or business associate.

The FDA Guidance Document delineates a number of cybersecurity controls that manufacturers of FDA-regulated medical devices should develop, particularly if the device has the capability of connecting (wirelessly or hard-wired) to another device, the internet, or portable electronic media. Perhaps these controls will become standard features of medical devices, but they might also be useful to developers of other types of health-related products marketed to or purchased by consumers. In the meantime, though, it’s important to remember that your device is not your doctor, and HIPAA may not be protecting the health data created, received, maintained or transmitted by your medical device.
Continue Reading Medical Device, “Heal Thyself” from Data Hacking