Aventor Releases its Top 10 Governmental Obstacles to Developing Connected Health Technologies for the Poor (2015 Edition)

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Dec 17, 2014, 09:51 ET

WASHINGTON, Dec. 17, 2014 /PRNewswire/ -- Aventor works to expand healthcare access in the United States for the economically disadvantaged using connected health technology – both mHealth and telemedicine. Since these new connected health technologies often disrupt existing paradigms for care delivery, for example calling upon nurses or pharmacists to manage patients in a way that hasn't been considered before, they frequently run into governmental obstacles. That's where Aventor comes in. Using the "low bono" model in which the professionals offer their services at greatly reduced rates, Aventor guides the social entrepreneurs through the labyrinth of federal and state regulation of health care.

Through a diligent process of consulting experts and experienced entrepreneurs in the field, Aventor identified the following Top 10 Government Obstacles in the United States, presented in reverse order of importance:

10. Medical product liability scares entrepreneurs away
9. ONC is developing standards that could become obstacles
8. Complex FCC rules must be navigated
7. Federal rules can inhibit needed collaboration
6. FDA's clearance and approval process has become outdated
5. Medicare coding processes and payment levels fail to encourage new connected health technologies
4. Privacy and security laws impose tremendous cost through complexity
3. FDA jurisdiction over connected health technologies is muddled, creating great uncertainty
2. Medicare and Medicaid fail to cover important connected health technologies
1. State regulation of health professionals Balkanizes healthcare, destroying much of the efficiencies that connected health technologies offer

Aventor's white paper explains in more detail how these obstacles conspire to prevent connected health technology from helping the economically disadvantaged get greater access to healthcare.

Aventor is taking applications until February 1, 2015, to select the first batch of social entrepreneurs it will support. For application and additional information, interested entrepreneurs can visit www.aventor.org.

Below we share some of the specific insights our experts offered:

"Medicare and Medicaid benefit structures and coverage/coding regimes form a static snapshot of how health care looks at a particular point in time," notes Ted Mannen, a Washington, D.C.-based life sciences attorney and advisor who served as General Counsel of what is now known as the Advanced Medical Technology Association. "Connected health technologies don't stand still, and so the Medicare/Medicaid snapshot needs frequent updating – an important pro-patient challenge that Aventor is well-positioned to address."
"There is a high hurdle to de-identify data to HIPAA or other specifications. Encryption and other technical controls will often be part of the price of innovation, and 'perfect security' is too high a standard. We need to offer entrepreneurs predictability and practical solutions that lesson the burden around low risk applications," explains Mark Lutes, Chairman of the Board of Directors of EpsteinBeckerGreen and a privacy law expert.
"Small companies, particularly those coming from the consumer space, need help coping with the regulatory and reimbursement issues that are required to succeed in this new market segment," observes Charles Parker, a Principal in Escentium Consulting and former Executive Director of the Continua Health Alliance. "Every aspect of healthcare is regulated. When these companies come in with new ideas unfettered by traditional thinking, they inevitably confront status quo-inspired rules that say they can't do what seems to make sense. They need a helping hand to guide them around known landmines, and to advocate for a new way of thinking."
"Government regulation in healthcare certainly presents challenges to innovation, primarily because it is the nature of entrepreneurs to 'color outside the lines', move quickly, and change often to achieve their objectives. However, via open collaboration with the regulators and with guidance from a knowledgeable organization like Aventor, this dichotomy often can be managed," explains Malinda Peeples, RN, MS, CDE. Peeples is Vice President of Clinical Advocacy at WellDoc, a digital health care behavioral science and technology company that launched BlueStar®, the world's first Mobile Prescription Therapy.
"FDA's regulatory process was designed before wireless technology was invented, and lacks an adequate and definitive structure for integrating wireless capabilities with legacy device technologies. Clear and consistent regulatory pathways based on patient risk would benefit everyone: Patients, Providers, Entrepreneurs and Government," suggests Colleen Hittle, Managing Director, Healthcare and Life Sciences Disputes, Regulatory, Compliance & Investigations, Navigant.
According to Rene Quashie, a partner at EpsteinBeckerGreen and a recognized leader in the field of telemedicine law, "There is a complete misalignment of state law, technology, and telemedicine practice which has led to an inconsistent patchwork of state laws and regulations governing telemedicine. Without better harmonization and consistency in state law and regulations, those laws will continue to be significant barriers to the wider adoption of telehealth."

About Aventor: Aventor, a newly launched nonprofit NGO, is a business accelerator that assists social entrepreneurs in overcoming obstacles to improving health care for low-income Americans. More specifically, Aventor is comprised of professionals in law, regulatory, reimbursement, privacy and security, government affairs and related disciplines who help the social entrepreneurs either navigate the existing regulatory requirements, or change the regulatory landscape.

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