telemedicine

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The New York City skyline, including the Empire State BuildingIn a post on February 28, Fox associate Kristen Marotta discussed the privacy and security issues arising from the growing use of telemedicine, particularly for mental health treatment. Now on the firm’s Physician Law blog, Kristen continues her discussion of telepsychiatry by diving into recent developments in New York State surrounding the innovative practice model. Kristen notes new funding from the New York Office of Mental Health to expand its use, and breaks down the OMH regulations that psychiatrists and physicians will need to consider before offering telepsychiatry services.

We invite you to read Kristen’s piece.

Kristen Marotta writes:

Many believe that educated millennials are choosing to work in urban, rather than rural areas, during their early career due to societal milestones being steadily pushed back and the professional opportunities and preferences of a young professional. Recent medical school graduates are a good example of this dichotomy. The shortage of physicians in rural areas is a well-known phenomenon. Over the years, locum tenens staffing has helped to soften the impact and, recently, so has telemedicine.

Illustration of stethoscope and mobile phone, symbolizing telemedicineThe growing prevalence of telemedicine around the country is an important consideration for new physicians as they decide where to settle down and establish their careers.  In New York, medical graduates should be aware that a $500,000 federal grant was given to New York State’s Office of Mental Health this month, February 2018 by the U.S. Department of Agriculture Rural Development Distance Learning and Telemedicine program.  Using telemedicine to provide mental health services may be a productive and efficient way to deliver healthcare, not only because many mental health examinations would not have to be conducted in-person, but also because of the general shortage of psychiatrists and mental health providers to meet these patient needs. Now, medical graduates who would like to establish their lifestyle in a city can simultaneously care for patients living miles apart from them.

It is essential that health care providers engaging in telemedicine understand the implications of this practice model with respect to compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Providers rendering health care services via telemedicine should update and adjust their security risk assessments and HIPAA privacy and security policies and procedures, because protected health information is likely to be created in two separate locations (i.e., the location of the provider and the location of the patient).  Providers should also make sure that their (or their practice’s) Notice of Privacy Practices has been updated to reflect the provision of services via telemedicine, so that the patient has the opportunity to make an informed decision about engaging in this type of health care. Additionally, new business associate agreements may be required with telehealth vendors that do not meet the narrow “mere conduit” exception and any new parties who will have access to the individual’s protected health information as a result of the provision of services via telemedicine. In connection with these efforts, Providers should research and conduct due diligence on vendors to confirm that they understand the services model and are HIPAA-compliant.

As telemedicine emerges and gains more traction in health care, state laws and regulations will also be created and/or updated, and physicians will need to keep abreast of these changes. A good example of this is the State of New York, which has an entire section of mental health regulations dedicated to telepsychiatry. Stay tuned to Fox Rothschild’s Physician Law Blog for further updates on these specific New York regulations, as well as the developments in telemedicine.

Kristen A. Marotta is an associate in the firm’s Health Law Department, based in its New York office.

As she has done in January for several years, our good friend Marla Durben Hirsch quoted my partner Elizabeth Litten and me in Medical Practice Compliance Alert in her article entitled “MIPS, OSHA, other compliance trends likely to affect you in 2017.” For her article, Marla asked various health law professionals to make predictions on diverse healthcare matters including HIPAA and enforcement activities. Full text can be found in the January 2017 issue, but excerpts are included below.

Marla also wrote a companion article in the January 2017 issue evaluating the results of predictions she published for 2016. The 2016 predictions appeared to be quite accurate in most respects. However, with the new Trump Administration, we are now embarking on very uncertain territory in multiple aspects of healthcare regulation and enforcement. Nevertheless, with some trepidation, below are some predictions for 2017 by Elizabeth and me taken from Marla’s article.

  1. The Federal Trade Commission’s encroachment into privacy and security will come into question. Litten said, “The new administration, intent on reducing the federal government’s size and interference with businesses, may want to curb this expansion of authority and activity. Other agencies’ wings may be clipped.” Kline added, “However, the other agencies may try to push back because they have bulked up to handle this increased enforcement.”
  2. Telemedicine will run into compliance issues. As telemedicine becomes more common, more legal problems will occur. “For instance, the privacy and the security of the information stored and transmitted will be questioned,” says Litten. “There will also be heightened concern of how clinicians who engage in telemedicine are being regulated,” adds Kline.
  3. The risks relating to the Internet of things will increase. “The proliferation of cyberattacks from hacking, ransomware and denial of service schemes will not abate in 2017, especially with the increase of devices that access the Internet, known as the ‘Internet of things,’ warns Kline. “More devices than ever will be networked, but providers may not protect them as well as they do other electronics and may not even realize that some of them —such as newer HVAC systems, ‘smart’ televisions or security cameras that can be controlled remotely — are also on the Internet and thus vulnerable,” adds Litten. “Those more vulnerable items will then be used to infiltrate providers’ other systems,” Kline observes.
  4. More free enterprise may create opportunities for providers. “For example, there may not be as much of a commitment to examine mergers,” says Kline. “The government may allow more gathering and selling of data in favor of business interests over privacy and security concerns,” says Litten.

The ambitious and multi-faceted foray by the Trump Administration into the world of healthcare among its many initiatives will make 2017 an interesting and controversial year. Predictions are always uncertain, but 2017 brings new and daunting risks to the prognosticators.  Nonetheless, when we look back at 2017, perhaps we may be saying, “The more things change, the more they stay the same.”

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.