[author: Mark J. Silberman]
mHealth Newsletter - November 14, 2012
Home health is an industry built on the core value of having hands-on-professionals providing quality healthcare in the comfort and privacy of the patient's home. The availability of reliable data is particularly key in home health, since the patient and his or her caregivers are not always in the same location as compared to a hospital or nursing home. When the caregiver is in the home, the information collected through patient assessments must be accurate and has to circulate back to the patient's physician and other caregivers as promptly as possible to determine and maintain optimum treatment. The patient can also benefit when caregivers share information with him or her about the treatment plan, including how the patient can be an active participant in his or her healthcare. Good data are thus necessary in home health to effect good outcomes and to engage the patient in his or her care experience.
mHealth software applications and devices provide the ideal tools to advance home healthcare through the prompt and targeted exchange of patient data. Numerous apps on smart phones, tablets and laptops, as well as stand-alone devices, can provide real-time information to healthcare professionals to monitor a patient's heart rate, blood pressure, sleep, blood oxygen levels, glucose levels and coagulation. A sample mHealth product that relies on a smartphone (or other platform) may include an accessory, such as a stethoscope, that is connected to the smartphone and a mHealth app that allows data to be collected through the accessory and sent to a provider. When the stethoscope is held up to the patient’s heart area, it can detect beats-per-second and then transmit the data through the app. The provider that receives the data can then use the data to monitor the patient's health and can share the information with other providers through an electronic health record or other means in order to determine treatment.
Less-complex mHealth apps exist that, for instance, can remind the patient to take his or her medicine with the use of a ringtone. The patient must then confirm through the app, such as by pressing a button on a touchscreen, that he or she has taken the medicine, along with the time. Other apps allow the patient at home to transmit to the physician real-time information on signs and symptoms—such as an emerging rash—via text, photo or video message. Finally, apps are available that educate the patient on healthy lifestyles and specific care instructions, such as how to clean a simple wound.
Concerns have been raised on whether mHealth devices and apps, especially those that support monitoring, diagnosis or clinical-care decision making, will cause home health to forego, or at least drastically minimize, the hands-on touch. The industry will have to find the right balance of providing care through technology and with flesh-and-blood professionals. Some of the clinical, legal and financial issues to consider are:
What standards of care will apply to the provision of care through mHealth? How will the licensing and accrediting agencies view mHealth? Is the provision of care through mHealth equivalent to the practice of medicine?
Which aspects of mobile health, i.e., the devices, applications and/or accessories or combinations thereof, will be reimbursable by the government and private insurers? If not reimbursable, who will pay (e.g., would the patient or the provider have to subscribe to a particular app).
How will the industry deal with the inherent risks and liabilities related to the electronic transmission of data? Who will ensure that the data are protected and properly transmitted (e.g., if your patient's network goes down or an alert from the monitoring device gets caught in your spam filter)? Depending on how data are transmitted, what is the role of the hosting company or other vendors engaged in the collection, storage and transmission process?
How will the government regulate mHealth?
With respect to government oversight, a number of agencies have their hands in the pot. The Food and Drug Administration is developing guidance for regulating mHealth devices, including apps and other software. The Department of Health and Human Services is considering mHealth and privacy issues. The Federal Trade Commission is closely watching the entire mobile app industry to ensure that apps are properly advertised and that the intended uses of the data are transparent to the user. Congress has also weighed in, requiring the agencies to develop an overall regulatory framework for mHealth.
A natural fit exists between home health and mobile health, given that, except for home visits and doctor's visits, patients and providers are not in the same place. mHealth is likely to continue to prove its value in the home health sector and aligns with anticipated changes in the U.S. healthcare system. The utilization of real-time monitoring devices in the home can assist in avoiding acute episodes, thereby reducing readmissions, a current high-level concern under Medicare. The ability to deliver care remotely and encourage patient engagement is likely to be attractive to accountable care organizations and other healthcare initiatives that are designed to reduce costs in the healthcare system. The advantages to the use of mHealth in home health are apparent—if issues like reimbursement and applicable laws can be resolved.
Mark J. Silberman practices in the area of health law. His practice focuses upon governmental and regulatory compliance in healthcare, with concentrations in healthcare litigation, healthcare-related white-collar criminal defense and all aspects of the Illinois Certificate of Need program. Mr. Silberman handles compliance and enforcement actions involving the Illinois Department of Public Health, Illinois Health Facilities and Services Review Board (formerly Health Facilities Planning Board) and Medicare/Medicaid programs. He also advises clients regarding pharmacy and pharmaceutical-related litigation, Stark laws, HIPAA, allegations of healthcare fraud and healthcare-related criminal conduct.