DOES TECHNOLOGY KEEP PATIENTS OUT OF HOSPITALS? Jeff Shuren, MD, JD Center for Devices and Radiological Health Food and Drug Administration November 6, 2014 1
Overview Challenges Medical Devices Used in the Home Connected/Digital Health Technologies Bottom Line Answer: Yes, it can 2
Is the juice worth the squeeze? Hospitalization is expensive Quality of life in the home setting is better than in health care facilities According to the CDC: Older Americans will increasingly constitute a larger percentage of the population 20% by 2030 By 2050, ~27 million people will need long-term care According to a 2009 Avalere Health study, home health care services saved Medicare $1.71 billion in 2005-2006 for diabetes, chronic obstructive pulmonary disease (COPD), and congestive heart failure (CHF) 3
Challenges faced when devices designed for the hospital setting are used in the home No access to, unclear or incomplete labeling for lay user Health literacy of the user Inadequate training available for lay user Devices not designed for the lay user or the home environment Not portable so you are tethered to one place instead of being able to move around No lockout mechanism, the lack of which can promote overdosing of medication 4
Challenges faced when devices designed for the hospital setting are used in the home - continued Possible ingress of pet fur and other contaminants Warning alarms not designed for a non-monitored, noisy environment Cleaning and maintenance of the device Contacting the manufacturer 5
Steps we are taking to facilitate the development and use of devices in the home The following information can be found on FDA s website: Checklist for devices going into the home Infusion therapy brochure Glucose meters brochure What to do in the event of a power outage booklet Sharps disposal information Patient lift information Final guidance Design Considerations for Devices intended for Home Use Proposed rule on the electronic submission of labeling for devices labeled for home use 6
Steps we are taking to facilitate the development and use of devices in the home - continued We are working with accrediting bodies to address devices and applicable standards We are working on medical device standards committees and have developed: An interventional standard for electrical equipment on the design of home use devices A technical information report addressing the training and proper instructions for use for the lay person 7
Steps we are taking to facilitate the development and use of devices in the home - continued We have conducted studies with health care professionals and lay persons regarding: How they use labeling What they want in labeling How they want access to labeling How they want labeling structured We are currently developing a study to test existing labeling of a device against a draft standard content of labeling 8
Devices designed for use in the home that have kept patients out of the hospital Home hemodialysis Peritoneal dialysis Apnea monitors Total parenteral nutrition (TPN) therapy for the ambulatory patient Phototherapy units Pacemakers and automatic implantable cardiac defibrillators with telemonitoring Telehealth: telediagnosis, telescreening, telemedicine, telemonitoring Oxygen therapy CHF monitoring equipment (BP, weight) well known for reduced hospital admissions Infusion pumps, implantable pumps, or infusors designed for the lay user Insulin pumps Left ventricular assist devices (LVADs) Shunts Peripherally inserted central catheter (PICC) lines Continuous positive air pressure (CPAP) machines 9
Connected/Digital Health Efforts 10
Examples of Software as a Medical Device EEG analysis software Radiation oncology software Lab information systems Diabetes management Radiology software Clinical lab software 11
Functionality Focused (EKG machine) 12
Smart Regulation Platform independent Promote innovation Promote patient engagement Protect patient safety Functionality focused Narrowly tailored Risk based 13
Health-Related Mobile Apps - Landscape Apple App Store 43,000 apps (health related categories) Healthcare & Fitness (23,728) + Medical (19,484) (according to http://148apps.biz/ as reported on September 09, 2013) The healthcare apps market is dominated by exercise apps. Sleep and meditation, and weight loss apps are expected to grow at the highest CAGR during the forecast period. September 2013 Researchandmarket report http://www.researchandmarkets.com/research/6hlqd6/mhealth_apps_and Breakdown of available health related apps M. Shaw., Health Digest News 96 % Calorie counting, Cardiovascular fitness, Strength training, Sleep improvement consumer focused Remaining 4 % more specialized apps, for e.g. remote patient monitoring
Mobile Medical Apps (MMA) Patient self-management apps Tools to organize and track their health information (not for treating or adjusting medications) Tools to access to health information document and communicate with health care providers Tools that automate simple health care provider tasks Enforcement Discretion MMA Focus of Oversig ht Lower risk mobile apps that meet device definition but not considered MMA No regulatory requirement s Mobile apps not considered medical devices Mobile apps that meet statutory device definition that are either intended To be used as an accessory to already regulated medical device, or To transform a mobile platform into a regulated medical device and Have been approved, cleared, or classified. 15
FDASIA Health lh IT Report FDASIA Section 618 - Charge g Charged FDA in consultation with ONC and FCC to develop and post on their respective web sites: a report that contains a proposed strategy and recommendations on an appropriate, risk based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication. Permitted the convening of external stakeholders and experts to provide input. 16
FDASIA Health IT Report Categories of Health IT Functionality Administrative Functionality* Admissions; Billing and claims processing; Practice and inventory management; Scheduling; General purpose communications; Analysis of historical claims data; Determination of health benefit eligibility; Reporting communicable diseases; Reporting on quality. No Additional Regulatory Oversight Health Management Functionality* Health information and data management; Data capture and encounter documentation; Electronic access to clinical results; Most clinical decision support; Medication management; Electronic communication (e.g. provider patient, providerprovider, etc.); Provider order entry; Knowledge management; Patient ID and matching. Primary Focus of Proposed Health IT Framework Medical Device Functionality* Computer aided detection software; Remote display or notification of real time alarms from bedside monitors; Radiation treatment therapy planning software; Arrhythmia detection. * Examples provided. Not intended to be an exhaustive list of functionalities. Primarily FDA Oversight 17
FDASIA Health IT Report Strategy and Recommendations for Health Management Health IT Framework Health IT Safety Center 18
Other areas of focus Medical Device Data Systems Wireless technologies: interference New international framework for Software as a Medical Device (SaMD) Interoperability Cybersecurity 19