Individuals who use healthcare apps such as fitness trackers,
weight loss, wellness, exercise, etc., BEWARE! A
couple of recent developments have highlighted the fact that most
apps are not subject to HIPAA, which means that with broadly-worded
privacy policy these healthcare apps can and do readily share
healthcare and other data collected by the apps with third parties,
including marketing and analytics companies, such as Google and
Facebook. Some apps are sharing sensitive healthcare data even
without a privacy policy.
The first eye-opening development was a study published in the
journal JAMA Network Open (JAMA Study) reported that a
number of healthcare apps marketed to people who wanted to stop
smoking or who had depression were providing user data, including
user health/medical information to third party advertisers and
analytics companies such as Facebook.
Notably, the JAMA Study was clear that much of the data the apps
reviewed shared did not immediately identify the individual user
nor was it strictly medical. However, all but 3 of the 36
apps reviewed shared information that was a valuable predictor of
individual behavioral conduct with advertisers or analytic
companies. A few apps also shared sensitive information including
substance use information app users had self-reported through the
various apps.
The JAMA Study was certainly not the first study of its kind. The
Wall Street Journal in a piece titled "You Give Apps Sensitive Personal Information. Then
They Tell Facebook" revealed that Flo, a period-tracking
app, shared users' health information, including period dates
and pregnancy plans, with third-party sites such as Facebook.
Other health apps have self-reported security flaws and/or to
sharing user personal health information with advertisers and
analytic companies. Not surprisingly, the revelation that private
health information was being shared to massive
information-gathering powerhouses stirred up a lot of questions,
such as:
- How could this happen?
- Isn't health/medical information private, not so easily shareable, or at least subject to higher privacy standards?
- What was communicated to the users about what information would be shared and how?
- What did the apps' privacy policies say about this
information sharing or, rather, what didn't the
privacy policies say?
How can health app users make informed decisions about whether they want to use an app if they don't know who will be given access to their personal health information?
These are all very valid questions, which is why it is
interesting that, around the same time that the JAMA Study was
released, the Department of Health & Human Services Office for
Civil Rights (HHS), which enforces HIPAA, issued five new FAQs
addressing the applicability of HIPAA to health-related apps.
Before diving into HHS's FAQs, it is important to preface that
most people assume that HIPAA protects health information from
disclosure or at least provides some higher level of security over
health information. However, HIPAA is narrower than most people
believe, which it why the FAQs are interesting in that they
demonstrate exactly where HIPAA's Privacy and Security Rule
protections end, especially as it pertains to healthcare apps, and
how health-information collection and sharing (as found in the JAMA
Study) is so profound.
The key to understanding how these healthcare apps can disclose so
much sensitive information unbeknownst to the users is
understanding that, in most instances, the healthcare apps at issue
are not covered by HIPAA and, therefore, not subject to HIPAA's
Security Rule and Privacy Rule requirements. That means the
healthcare data those app companies collect is also not protected
by HIPAA's protections.
HIPAA does not provide a blanket, overarching protection to all
medical/health/wellness information. HIPAA is limited to
"covered entities" and their "business
associates" who are sharing "protected health
information" ("PHI" or "ePHI" when
discussing electronic information) concerning "covered
transactions". All of the quoted terms are specifically
defined by HIPAA and most third-party healthcare apps do not
qualify as a "covered entity", a "business
associate", as having "PHI" or as engaging in a
"covered transaction" for purposes of triggering
HIPAA's requirements.
Looking to HHS's FAQs, they are specific to
transactions between a patient, a healthcare provider, and the
healthcare provider recommending a course of treatment that
includes transmitting healthcare information to an app. This, in
and of itself, sheds a tremendous amount of light as to how so much
PHI information is not protected by HIPAA.
*** FAQ 572 ***
For instance, the first FAQ addresses whether a covered entity
is liable under HIPAA if it sends ePHI to an app at the
patient's request and the app discloses that information. This
FAQ is important for understanding why third-party apps, which are
wholly unaffiliated with any covered healthcare entity, can
disclosure or otherwise share healthcare information without
violating HIPAA.
As the FAQ answer makes clear, the key to determining how much
protection a particular piece of PHI has is to understand the
relationship between the healthcare provider that is recommending
or requiring a patient to use a particular app and the app
developer itself. If the app itself is developed by or on behalf of
the healthcare covered entity, then the use of that app would be
subject to HIPAA protections because the app developer would be
either a covered entity or a business associate to the healthcare
provider as defined by HIPAA. If, however, there is no such
relationship and the app is strictly a third-party app with no
affiliation to the healthcare provider, such as all those reviewed
in the JAMA Network Open study, HIPAA would not apply or offer any
protections for the disclosure of or sharing of PHI.
In other words, once health information is received from a covered
entity, at the individual's direction by an app that is neither
a covered entity nor a business associate (as defined under HIPAA),
the information has lost its HIPAA protection it might have once
had. This means that any subsequent use, disclosure, etc., of e-PHI
by the non-covered entity would not trigger liability under HIPAA
and no up-the-chain liability for the healthcare provider in the
event of a breach, misuse, etc.
If, however, the app was developed for and/or provided on behalf of
the covered healthcare provider, the covered healthcare provider
would be liable for any breach or other improper disclosure of
PHI.
Putting this into application, think about an app that is provided
by and/or developed for a healthcare provider, such as a hospital.
The app can be used to help patients check their records, schedule
appointments, review their invoices, etc. That app and any use of
the information provided by patients through the app would be
subject to HIPAA's protections.
Conversely, a fitness tracking, wellness or health monitoring app
that is advertised via Facebook, Instagram, or by other means, is
found via the App Store, has no affiliation to a hospital or
clinic, and was not recommended by a healthcare provider would not
be subject to HIPAA.
*** FAQ 573 ***
The next FAQ is interesting because it analyzes whether a
covered entity is liable if is grants an individual's request
to send their PHI using an unsecured method to an app. It is not
surprising that HHS determined that the covered entity would not be
liable for unauthorized access to an individual's PHI if the
individual requests their PHI be sent to an app via an unsecure
method. It is surprising to most that this is even an option and
that, somehow, an individual can somehow direct his or her PHI to
be sent electronically through an unsecure channel.
The real issue identified here is not in HHS's answer, but
rather brought to light with the knowledge that somehow individuals
can consent to the unsecured transmission of their PHI because who
would actually do that and why. As to the why, well, it is postured
as a matter of convenience. As to who, well, the answer is that
most people have no idea they are consenting to this. This consent
is usually obtained when a patient arrives for a doctor's
appointment and has to sign the HIPAA Privacy Notice that is put in
front of them as the patient signs in for an appointment. Somewhere
in that notice is a request for consent to allow PHI to be sent via
unsecured channels if deemed quicker or more convenient by the
healthcare provider.
The FAQ makes it clear that if PHI is sent this way via the
individual's consent, the healthcare provider would not be
liable for any loss that may occur during transmission to the app.
HHS recommended, but did not require, that covered entities inform
individuals of the potential risks involved in consenting to an
unsecured transmission.
*** FAQ 574 ***
The next FAQ addressed liability after transmission by a covered
entity's electronic health record system in the event a patient
directs a covered entity to send PHI to a particular app. Again,
and in line with the key issue identified initially above, HHS
determined that the answer depends on the relationship, if any,
between the covered entity, the EHR-system developer, and the
app.
Here, a business associate relationship exists if the entity
creates, receives, maintains, or transmits PHI on behalf of a
covered entity in order to execute covered transactions of the
covered entity.
No such business associate relationship exists between an
EHR-system developer if the EHR-system developer does not own the
app or, if it does, does not provide the app to, through or on
behalf of the covered entity. For example, if the EHR-system
developer creates an app, makes it available via the App Store as
part of an entirely separate revenue stream or business unrelated
to its role as a business associate to a healthcare covered entity,
then it would not be liable under HPAA for any PHI use or
disclosure it receives via its app.
***FAQ 575***
Another FAQ addressed whether a covered entity could refuse to
disclose a patient's PHI if it had concerns about the app's
use or disclosure of the PHI. HHS determined that the covered
entity's concerns were irrelevant because HIPAA general
prohibits a covered entity from refusing to disclose PHI to a
third-party app as requested by an individual if the PHI is in a
form/format used by the app. This disclosure is allowed based on
the individual's right of access under HIPAA. The other side of
this is that the covered entity also does not bear responsibility
for any misuse of the PHI during or after it transmits such data
pursuant to an individual's request. And since the third-party
app also bears no responsibility since it is not covered by HIPAA,
it is really the individual who shoulders all the risk if he or she
asks his/her ask their healthcare provider to transmit their PHI to
a third-party app.
***FAQ 576***
The last FAQ analyzed whether HIPAA requires a covered entity or
its EHR-system developer to enter into a business associate
agreement with an app designated by the individual before
transmitting PHI to the third party's app. Again, the answer is
dependent on the relationship between the app developer and the
covered entity and/or its EHR-system developer.
As set forth in other FAQ analysis, HHS reasserted its position
that HIPAA does not require a covered entity or its EHR-system
developer to enter into a business associate agreement with an app
developer if the app does not create, receive, maintain or transmit
PHI on behalf of or for the benefit of the covered entity.
If, however, the app was developed on behalf of the covered entity
or provided by the covered entity, then a business associate
agreement would be required because HIPAA would be triggered by the
nature of the relationship.
What about the apps' privacy policies?
The other interesting tidbit to come out of the JAMA Study was how little the apps' privacy policies disclosed about how PHI would be shared. In some cases, the privacy policies were completely silent in this area. The issue then, and rightfully so, is how can the app developers get away with inaccurate privacy policies? The answer is that the oversight for privacy policies that are not covered by HIPAA are also not enforced by HHS; rather, they are subject to enforcement by the Federal Trade Commission. The FTC has levied fines and penalties against some website and app developers for miscommunications in their privacy policies, as the FTC considers the issue a matter of fraud under Section 5 of the Federal Trade Communication Act, but enforcement in this area is behind the technology. So, while the FTC has the enforcement power to make these app developers be honest and clear about their information sharing and disclosing practices, it is likely that there are just too many to go after and information such as the findings of the JAMA Study is just starting to shed light on this situation.
Takeaways
The key takeaway here is that app users bear the bulk of responsibility when they choose to input their personal health or other information into apps.
Health information does not have a universal protection and HIPAA is extremely limited as to its protections to such apps.
Even if the app is subject to HIPAA, there are a number of ways
information can be disclosed via individual consent – and
sometimes via consent the individual is not even sure they are
granting.
When it comes to healthcare, wellness, fitness tracking, and other
apps, it is critical for users to remember that the widespread
information sharing to third party advertisers and analytics sites,
such as Facebook and Google, applies exactly the same as it occurs
with other information such as shopping preferences. An entity
cannot share information that is not disclosed to it. So, unless an
individual is sure the app he or she is using is covered under
HIPAA and that does not otherwise allowed information to be shared
to a third-party app via unsecured means, users must understand
that information shared to an app may very well be shared to many
other entities and people.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
