Prove It or Lose It: The FTC’s Standard for Scientific Support of Medical App Claims

Medical-Apps-in-HealthcareBy Julie Liu

Among the countless mobile applications that allow us to control much of our lives, the growing wave of medical apps allows us to manage and improve our health with the convenience of a phone or tablet. But, as illustrated by the Federal Trade Commission’s approval of its final order against the maker of the UltimEyes app, this possibility comes with important limitations. Continue reading

The 21st Century Cures Act Will Be Implemented Piecemeal

fdaBy Jason Liu

As technology and medicine advance, the need to streamline and regulate medicine will increase. One can visit a virtual doctor, connect medical devices to the internet, and access cutting-edge gene therapy precision medicine. However, government agencies work with laws that never considered these innovations. To update these laws, the House passed the 21st Century Cures Act in 2015. The Act currently sits in the Health, Education, Labor and Pensions Senate (HELP) committee. Congress may also break the bill into smaller pieces of legislation.

Lamar Alexander (R-Tenn.), the leader of the HELP committee, recently stated that the panel will divide the 21st Century Cures Act into smaller pieces of legislation. The Act has stalled in the Senate because Democrats and Republicans disagree on how to fund the bill. Beginning Feb. 9, the committee will vote on at least seven bipartisan bills ranging from expediting therapies for rare diseases to improving electronic health records. Continue reading

New York Telehealth Law Raises Hopes for Access, Targets Concerns about Billing

Screen Shot 2015-01-20 at 9.11.32 AMBy Alex Boguniewicz

A new year, new legislation, new legal issues. New York rang in 2015 by becoming the 22nd state to enact a telehealth parity law. The law requires that deductibles, co-insurance, and other coverage conditions for telemedicine be treated the same as payments for typical in-person hospital visits. As such, commercial insurers will be required to cover telehealth and telemedicine services, starting at the end of this year. The new law is an exciting development for patients, especially in rural areas, who have previously had limited options in health services. For payers and providers, however, questions remain about the feasibility of this law and how it could impact the entire healthcare reimbursement landscape.

Telehealth and telemedicine have been among the most significant developments in healthcare delivery in decades. Though the terms telehealth and telemedicine are often mistakenly used interchangeably in everyday conversation, they in fact refer to separate modes of delivery, as made explicit by the New York law. Under the statute, “telehealth” means healthcare delivery services through “communications technologies consisting of telephones, remote patient monitoring devices or other electronic means.” The electronic communications facilitate the assessment, diagnosis, consultation, treatment, education, and management and self-management of care while the patient is at the “originating site”—the place where the patient is located when services are provided—and the healthcare provider is at a “distant site.” Telehealth also encompasses non-real-time means of “communicating” health data, and includes devices that transmit a patient’s vital signs to the health care provider. “Telemedicine,” on the other hand, refers to real-time two-way audio-visual communication aimed at assessment, diagnosis, consultation, etc. Thus, telemedicine is more akin to a typical doctor’s visit, with the patient interacting with the healthcare provider as if in the examination room. Continue reading