Harnessing Wireless Innovations

The House Energy and Commerce’s Subcommittee on Commerce and Technology, Health, Oversight and Investigations held three days of hearings titled “Health Information Technology: Harnessing Wireless Innovation”. Potential regulations and taxes on smartphones, tablets, mobile apps, and federal regulations were discussed. In the three days, a number of witnesses expressed their viewpoints.

Robert Jarrin, Senior Director Government Affairs for Qualcomm Incorporated explained that on July 2011, the FDA issued a Draft Guidance on Mobile Medical Applications (MMA). Officials from FDA said that the final MMA guidance document would be de-regulatory. It is now March 2013, and the FDA has yet to release a final MMA guidance document. This has led to confusion, apprehension, and in some cases, reluctance by mobile health app developers to enter the market for fear of regulation

Representing the Newborn Coalition, Jim Bialick the Executive Director, told the Committee that medical apps are not medical devices so it was a surprise when the FDA issued their draft guidance to regulate mHealth apps as medical devices.

Benjamin M. Chodor, CEO, Happtique Inc., explained that unlike other aspects of the healthcare marketplace there is little to no barrier to entry into the health app market which means that basically anyone with an idea and programming skills can build a mobile health app but many are unaware of the regulatory landscape. What is needed is a balanced, risk-based approach to regulations.

Representing the mHealth Regulatory Coalition, Bradley Merril Thompson, General Counsel agreed that over regulating apps will negatively impact manufacturers and developers who have to comply with requirements that are disproportionate to the very low risk level of these products.

According to, Joseph M. Smith, MD, PhD, Chief Medical and Science Officer at West Health Institute, suggested “What is needed are streamlined, predictable, transparent, risk-based regulations, development of proactive regulations and reimbursement based on true functional interoperability, and development of a reimbursement policy that would align stakeholder’s incentives to drive the adoption of appropriate technology.”

After the multi-day hearing highlighted a great deal of uncertainty related to medical device taxes and regulations, FDA’s Christy Foreman, Director of the Office of Device Evaluation in the Center for Devices and Radiological Health (CDRH), informed the Committee members that FDA’s policy on mobile medical apps will not include the regulation of consumer’s smartphones or tablets.

She continued to say, “FDA is consulting with ONC and FCC and plans to prepare a report by January 2014 with a proposed strategy and recommendations for an appropriate risk-based regulatory framework for health IT that will include mobile medical apps.

Go to http://energycommerce.house.gov/hearing/health-information-technologies-harnessing-wireless-innovation for more information.

Collaboration to Share Info

Today, life sciences organizations are managing in an environment with new responsibilities, questions, and critical choices. To deal with these issues, the Premier Healthcare Alliance has just launched the Healthcare Innovators Collaborative to enable the sharing of knowledge from health systems that are implementing ACOs. Premier’s research on care coordination, new payment models, resource utilization, and more will be available.

Several organizations have already joined the collaborative including ARUP Laboratories Inc., Baxter, Bayer HealthCare Pharmaceuticals, Inc., Eli Lilly, Integrated Healing Technologies LLC, Johnson & Johnson Health Care Systems Inc., and Ethicon Inc. Charter level enrollment is limited and is currently open for 14 more organizations to join by March 31, 2013.

The group will be provided the latest news on healthcare reform topics, issues, and legislation. Charter members will have access to insights gained through Premier’s PACT™, QUEST® and Bundled Payment Hospital and Health System Performance improvement collaboratives.

Detailed data will be provided on:

  • Care delivery and integration changes
  • New payment models
  • Utilization
  • Engagement and cost measurements
  • Patient-centered medical homes
  • Drug and device management
  • Data warehousing
  • High-value care networks

 

The Collaborative is led by a panel of experts including representatives from the Institute for Healthcare Improvement and the Mark Dixon Group LLC as well as Premier’s executive leadership.

This type of collaboration and innovation can help aid the sharing of best practices to identify better ways to support health systems and the communities they serve,” said Wes Champion, Senior VP of Premier Performance Partners.

To join the current charter members, email scott_pope@premierinc.com or call Alven Weil at (704) 816-5797.

Funding New Companies

 PatientStream, a new company that developed an innovative electronic patient tracking system for hospitals, has received $500,000 in funding from the W Fund and partners. The W Fund is a $20 million private venture fund focusing on earliest-stage investments in technology-based start-up companies doing research in the State of Washington.

The system is being used in more than 50 departments across UW’s Medical Center, Harborview Medical Center, Seattle Cancer Care Alliance, and Northwest Hospital. In an outpatient department at Harborview Medical Center, patient satisfaction improved by 25 percent after implementing PatientStream which actively monitors patient wait times, so that when a patient waits too long, an alert is sent to a team member who will expedite the patient’s visit.

CEO Ben Andersen developed the technology with Peter Ghavami at UWs Harborview Medical Center and co-founded PatientStream with COO Keith Strekenbach. “We have improved our efficiency of operations by 90 percent which means that surgeries now start on time 80 percent of the time,” said Don Millbauer, Director of Perioperative Services at Harborview Medical Center.

Clearside Biomedical Inc., an Atlanta based ophthalmic pharmaceutical start-up company launched from research at Emory University and Georgia Tech, recently received $7.9 million in funding to continue drug and technology development for the treatment of ocular diseases. The new funding is in addition to a $4 million venture capital investment received by Clearside Biomedical in early 2012 that served as the foundation for the start-up company. 

Santen Pharmaceuticals Co., Ltd in Osaka, Japan will fund Clearside’s technology development and has entered into a research collaboration agreement for posterior ocular diseases. Santen along with new investor Mountain Group Capital and affiliates joins current investors Hatteras Venture Partners in Durham, the Georgia Research Alliance Venture Fund, and the University of North Carolina’s Kenan Flagler Business School Private Equity Fund. 

Clearside is developing microinjection technology that uses hollow microneedles to precisely deliver drugs to a targeted area at the back of the eye. If the technique proves successful in clinical trials and wins regulatory approval, it could provide an improved method for treating diseases including age-related macular degeneration and glaucoma, as well as other ocular conditions related to diabetes.

Addressing Care Coordination

Bill (SB 1068) on care coordination for chronic diseases was introduced in the State of Connecticut by the Public Health Committee during the General Assembly’s January 2013 session. The bill calls for the Commissioner of Public Health to consult with the Comptroller and representatives of hospitals, healthcare facilities, along with local and regional health departments to develop a plan to meet the needs of the chronically ill.

The goal is to reduce the incidence of chronic diseases, improve chronic care coordination, and reduce the incidence and effects of chronic disease in healthcare facilities. The bill proposes that each year by January 15th, a report must be submitted to the General Assembly and then to the Joint Committee on Public Health. The annual report would be posted on the Department of Public Health’s web site within 30 days.

Each report would need to include information on but not be limited to:

  • A description of the chronic diseases that are most likely to cause a person’s death or disability
  • The approximate number of persons affected by chronic diseases and an assessment of the financial effects of each disease on the state, hospitals, and healthcare facilities
  • A description and assessment of programs and actions that have been implemented by the department, hospitals, and healthcare facilities to improve chronic care coordination
  • The source and amounts of funding received by the department to treat persons with multiple chronic conditions that are the most prevalent in the state
  • A description of the chronic care coordination that exists between the Department of Public Health, hospitals, and healthcare facilities
  • Detailed recommendations on actions that need to be taken by hospitals and healthcare facilities and recommendations to reduce hospital readmission rates, and how to achieve effective drug therapy monitoring
  • Identify future goals for coordinating care and reduce the incidence of persons having multiple chronic conditions

 

The legislation was referred to the Joint Committee on Public Health and a public hearing is expected to be held in March.  

 

 

 

 

 

 

Grants for Rare Disease Research

Representative Barbara Lee form California introduced the bill “Neuromyelitis Optica (NMO) Consortium Act” (H.R. 660) to provide grants to do research on the causes, risk factors, and biomarkers associated with NMO. So far, there has not been a comprehensive study that analyzes all the relevant clinical, biological, and epidemiological aspects of NMO that can be used to identify potential risk factors and biomarkers for NMO

NMO an uncommon disease syndrome can attack the central nervous system This devastating neurologic disease can lead to blindness and paralysis and it is estimated there are 11,000 patients with NMO in the U.S. Women are affected 7 to 9 times more than men and a large proportion of NMO patients are African-American.

NMO is a central nervous system disorder causing primarily swelling and inflammation of the eye nerves and the spinal cord. NMO occurs when the body’s immune system reacts against its own cells in the central nervous system that occurs mainly in the optic nerves and spinal cord, but sometimes in the brain

NMO was once thought of as a variant of MS and is still sometimes misdiagnosed as MS. Yet it differs from MS, since NMO does not often involve the brain, severe attacks are more robust as compared to MS, and the pathophysiology differs from MS.

According to NIH’s National Institute of Neurological Disorders and Stroke (NINDS), there is no cure for NMO, but there are therapies to treat an attack while it is happening to reduce symptoms and to prevent relapses. Doctors usually treat an initial attack of NMO with a combination of a corticosteroid drug to stop the attack and an immunosuppressive drug to prevent subsequent attacks.

Representative Lee’s bill would enable the Director of NIH in collaboration with the Director of the National Institute on Minority Health and Health Disparities to coordinate the efforts to establish a National Neuromyelitis Optica Consortium.

The legislation would enable the Consortium to provide grants for not fewer than five years so that the Consortium would be able to conduct research on a minimum of 25 individuals diagnosed with NMO.

The Consortium would be responsible to design a common study, develop standard protocols, methods, procedures, and assays to use with individuals enrolled as study participants, develop specific analytical methods for examining data, and provide provisions to review enrolled cases. Another objective would be to designate a central laboratory to collect, analyze, and aggregate data with respect to the research and then make this data and analysis available to researchers.

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Mass HIway to Fund $2 Million

The Massachusetts eHealth Institute (MeHI) at the Massachusetts Technology Collaborative has announced that $2 million is available to fund projects that catalyze connections to the statewide Health Information Exchange called the “Mass HIway”. Successful proposals will aim toward measurable improvements in care quality, population health, and cost containment through use of health information technology and the Mass HIway.

The Mass HIway program is funded through HHS in the Office of the National Coordinator (ONC) of Health IT. ONC has designated funds in support of states and their efforts to rapidly build capacity for exchanging health information across the healthcare system. The “Last Mile Program” is working collaboratively with the State Executive Office for Health and Human Services and is using program funding to fund the Mass HIway Implementation Grants.

Applicants may apply for grant awards for amounts up to $75,000 with proposals due April 16, 2013 with awards to be announced in May.  Applicants will need to perform some or all of the following steps:

  • Determine how you intend to leverage the Mass HIway
  • Partner with organizations to exchange information
  • Select connection options
  • Sign the Mass HIway participation agreement and agree to the Mass HIway enrollment fee structure
  • Load participants into the Participant Directory
  • Use the Mass HIway to refine workflows

 

The Mass HIway team is hosting online information sessions throughout March. For more information, on the “Mass HIway Implementation Grants Solicitation” (2013-MeHI-09), go to www.mehi.masstech.org/hiway-implementation-grants.

NSF’s Connected Health Program

The National Science Foundation (NSF) through their Directorate for Computer & Information Science & Engineering (CISE) have issued solicitation (13-543) for their “Smart and Connected Health” (SCH) program. SCH’s goal is to support the much needed transformation of healthcare from reactive and hospital-centered care to preventive, proactive, evidence-based, person-centered, and focused on well-being rather than disease.

The purpose of the program is to develop next generation healthcare solutions and encourage existing and new research communities to focus on breakthrough ideas in a variety of areas of value to health. These areas may include sensor technology, networking, information and machine learning technology, decision support systems, modeling of behavioral and cognitive processes, as well as system and process modeling. (more…)

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