The new Apple Watch Series 4® is one of the more recent and sophisticated consumer health engagement tools. It includes a sensor that lets wearers take an electrocardiogram (ECG) reading and detect irregular heart rhythms. The U.S. Food & Drug Administration (FDA) recently approved these functions as Class II medical devices, which generally means that they have a high to moderate risk to the user. The FDA approval letters describe the Apple Watch Series 4 functions as intended for over-the-counter use and not to replace traditional methods of diagnosis or treatment.

Tech developers and HIPAA lawyers often mean different things when describing a health app or medical device as HIPAA compliant. For example, a health app developer will likely focus on infrastructure, whereas the lawyer will likely focus on implementation. When asked about HIPAA, the app developer might rely on International Organization for Standardization (ISO) certification to demonstrate its data privacy and security controls and highlight how the infrastructure supports HIPAA compliance. The HIPAA lawyer, on the other hand, will likely focus on how (and by whom) data is created, received, maintained and transmitted and must look to the HIPAA regulations and guidance documents issued by the U.S. Department of Health and Human Services (HHS) to determine when and whether the data is subject to HIPAA protection. ISO certification does not equate to HIPAA certification; in fact, there is no HIPAA compliance certification process, and it is often difficult from the outset to determine if and when HIPAA applies.

As discussed in this prior blog post, HHS’s guidance on various “Health App Scenarios” underscores that fact that health data collected by an app may be HIPAA-protected in some circumstances and not in others, depending on the relationship between an app developer and a covered entity or business associate. The consumer (or app user) is unlikely to understand exactly when or whether HIPAA applies, particularly if the consumer has no idea whether such a relationship exists.

Back to the Apple Watch Series 4, and the many other consumer-facing medical devices or health apps in already on the market or in development. When do the nuances of HIPAA applicability begin to impede the potential health benefits of the device or app? If I connect my Apple Watch to Bluetooth and create a pdf file to share my ECG data with my physician, it becomes protected heath information (PHI) upon my physician’s receipt of the data. It likely was not PHI before then (unless my health care provider told me to buy the watch and has process in place to collect the data from me).

Yet the value of getting real-time ECG data lies not in immediate user access, but in immediate physician/provider access. If my device can immediately communicate with my provider, without my having to take the interim step of moving the data into a separate file or otherwise capturing it, my physician can let me know if something is of medical concern. I may not want my health plan or doctor getting detailed information from my Fitbit® or knowing whether I ate dessert every night last week, but if I’m at risk of experiencing a medical emergency or if my plan or provider gives me an incentive to engage in healthy behavior, I may be willing to allow real-time or ongoing access to my information.

The problem, particularly when it comes to health apps and consumer health devices, is that HIPAA is tricky when it comes to non-linear information flow or information that changes over time. It can be confusing when information shifts from being HIPAA-protected or not, depending on who has received it. As consumers become more engaged and active in managing health conditions, it is important that they realize when or whether HIPAA applies and how their personal data could be used (or misused) by recipients. Findings from Deloitte’s 2018 consumer health care survey suggest that many consumers are interested in using apps to help diagnose and treat their conditions. For example, 29% were interested in using voice recognition software to identify depression or anxiety, but perhaps not all of the 29% would be interested in using the software if they were told their information would not be protected by HIPAA (unless and until received by their provider, or if the app developer was acting as a business associate at the time of collection).

Perhaps certain HIPAA definitions or provisions can be tweaked to better fit today’s health data world, but, in the meantime, health app users beware.

We know by now that protected health information (PHI) and other personal information is vulnerable to hackers.  Last week, the Washington Times reported that the Department of Health and Human Services (HHS), the agency responsible for HIPAA enforcement, had suffered security breaches at the hands of hackers in at least five separate divisions over the past three years.  The article focused on a House Committee on Energy and Commerce report that described the breaches as having been relatively unsophisticated and the responsible security officials as having been unable to provide clear information regarding the security incidents.

We know it’s not a question of “if” sensitive information maintained electronically will be compromised by a hacking or other type of cyber security incident, but “when” — regardless of who maintains it — and how destructive an incident it will be. Even HHS and its operating divisions, which include both the Office of Civil Rights (OCR), charged with protecting PHI privacy and security, and the Food and Drug Administration (FDA), the country’s principal consumer protection and health agency, are vulnerable.

Just one day before its coverage of the House Committee report on the cyber security vulnerabilities that exist within the very government agencies charged with protecting us, the Washington Times reported on an even more alarming cyber security risk: the vulnerability of common medical devices, such as x-ray machines and infusion pumps, to hacks that could compromise not just the privacy and security of our health information, but our actual physical health.

This report brought to mind a recent report on the ability of hackers to remotely access the control systems of automobiles.  While the thought of losing control of my car while driving is terrifying, the realization that medical devices are vulnerable to hackers while being used to diagnose or treat patients is particularly creepy.  The two situations may present equally dangerous scenarios, but hacking into a medical device is like hacking into one’s physical being.

So while it’s one thing to have PHI or other sensitive information compromised by a hacking incident, it’s much more alarming to think that one’s health status, itself, could be compromised by a hacker.

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.