Contact Us
Subscribe to this blog via RSS
Join us on LinkedInCategories
- DEI
- Medical Cannabis
- SB 47
- Workplace Violence
- Assisted Living Facilities
- Department of Health and Human Services' Office of Civil Rights
- Medical Residents
- EMTALA
- FDA
- Reproductive Rights
- Roe v. Wade
- SCOTUS
- Medical Spas
- medical billing
- No Surprises Act
- Mandatory vaccination policies
- Workplace health
- Coronavirus Aid, Relief and Economic Security Act
- Code Enforcement
- Department of Labor ("DOL")
- Employment Law
- FFCRA
- CARES Act
- Nursing Home Reform Act
- COVID-19
- Families First Coronavirus Response Act
- Family and Medical Leave Act (“FMLA”)
- SB 150
- Acute Care Beds
- Clinical Support
- Coronavirus
- Emergency Medical Services
- Emergency Preparedness
- KBML
- medication assisted therapy
- Department of Health and Human Services
- Legislative Developments
- Corporate
- United States Department of Justice ("DOJ")
- Employee Contracts
- Non-Compete Agreement
- Opioid Epidemic
- Sexual Harassment
- Health Resource and Services Administration
- House Bill 333
- Litigation
- Medical Malpractice
- Senate Bill 79
- Locum Tenens
- Physician Prescribing Authority
- Senate Bill 4
- Chronic Pain Management
- HIPAA
- Prescription Drugs
- "Two Midnights Rule"
- 340B Program
- EHR Systems
- Electronic Health Records (“EHR")
- Hospice
- ICD-10
- Kentucky minimum wage
- Minimum wage
- Primary Care Physicians ("PCPs")
- Skilled Nursing Facilities (“SNFs”)
- Uncategorized
- Affordable Insurance Exchanges
- Compliance
- Department of Health and Human Services (HHS)
- Drug Screening
- Fraud
- Health Care Fraud
- HIPAA Risk Assessment
- HPSA
- KASPER
- Kentucky Board of Medical Licensure
- Kentucky’s Department for Medicaid Services
- Mental Health Care
- Office for Civil Rights ("OCR")
- Office of Inspector General of the United States Department of Health and Human Services (OIG)
- Pharmacists
- Physician Assistants
- Qui Tam
- Stark Laws
- Urinalysis
- Accountable Care Organizations (“ACO”)
- Affordable Care Act
- Alternative Payment Models
- Anti-Kickback Statute
- Centers for Medicare & Medicaid Services (“CMS”)
- Certificate of Need ("CON")
- Charitable Hospitals
- Data Breach
- Electronic Protected Health Information (ePHI)
- False Claims Act
- Federally Qualified Health Centers (“FQHCs”)
- Fee for Service
- Health Information Technology for Economic and Clinical Health Act (HITECH Act)
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Health Professional Shortage Area ("HPSA")
- Hospitals
- HRSA
- Kentucky Board of Nursing
- Limited Services Clinics
- Medicaid
- Medical Staff By-Laws
- Medically Underserved Area ("MUA")
- Medicare
- Mid-Level Practitioners
- Part D
- Patient Protection and Affordable Care Act (“ACA”)
- Rural Health Centers (“RHCs”)
- Rural Health Clinic
- Telehealth
- American Telemedicine Association (“ATA”)
- APRNs
- Criminal Division of the Department of Justice (“DOJ”)
- Health Care Fraud Prevention and Enforcement Action Team (“HEAT”)
- Hydrocodone
- Kentucky Pharmacists Association
- Qualified Health Care Centers (“FQHC”)
- Telemedicine
- United States ex. Rel. Kane v. Continuum Health Partners
- Webinar
- Agreed Order
- All-Payer Claims Database ("APCD")
- Chain and Organization System (“PECOS”)
- Chiropractic services
- Clinical Laboratory Improvement Amendments of 1988 (“CLIA”)
- Douglas v. Independent Living Center of Southern California
- Drug Enforcement Agency ("DEA")
- Emergency Rooms
- Enrollment
- Hinchy v. Walgreen Co.
- Jimmo v. Sebelius
- Kentucky Senate Bill 7
- Maintenance Standard
- Medicare Part D
- Minors
- Ophthalmological services
- Overpayments
- Physician Compare website
- Re-validation
- Texting
- Vitas Innovative Hospice Care
- 2014 Medicare Physician Fee Schedule (“PFS”)
- 501(c)(3)
- Affinity Health Plan
- Appeal
- Cadillac tax
- Centers for Disease Control and Prevention
- Chronic Care Management
- Community health needs assessment (“CHNA”)
- Compliance Officer
- Compounding
- Condition of Participation ("CoP")
- CPR
- Denied Claims
- Dispenser
- Drug Quality and Security Act (“DQSA”)
- Essential Health Benefits
- Federation of State Medical Boards (“FSMB”)
- Food and Drug Administratio
- Form 4720
- Grace Period
- HealthCare.gov
- Home Medical Equipment Providers
- House Bill 3204
- ICD-9
- Individual mandate
- Inpatient Care
- Kentucky Medical Practice Act
- Kindred v. Cherolis
- Kynect
- Licensure Requirements
- Long-term care communities
- Long-Term Care Providers ("LTC")
- Medicare Shared Saving Program (MSSP)
- Mobile medical applications ("apps")
- Model Policy for the Appropriate Use of Social Media and Social Networking in Medical Practice (“Model Policy”)
- National Drug Code ("NDC")
- National Institutes of Health
- New England Compounding Center ("NECC")
- Nonprofit hospitals
- Outsourcing facility
- Personal Service Entities
- Physician Payments
- Ping v. Beverly Enterprises
- Power of Attorney ("POA")
- Prescriber
- Qualified Health Plan ("QHP")
- Social Media
- Spousal coverage
- State Health Plan
- Sustainable Growth Rate (“SGR”)
- UPS
- “Superuser”
- "Plan of Correction"
- Advanced Practice Registered Nurses
- Arbitration
- Audit
- Autism/ASD
- Business Associate Agreements
- Business Associates
- Call Coverage
- Daycare centers
- Decertification
- Department of Medicaid Services’ (“DMS”)
- Division of Regulated Child Care
- Doe v. Guthrie Clinic
- EHR vendor
- Employer Group Health Plans
- Employer Mandate
- ERISA
- Fair Labor Standards Act (FLSA)
- False Billings
- Group Purchasing Organizations ("GPO")
- Health Professional Shortage Areas (“HPSA”)
- Health Reform
- Home Health Prospective Payment System
- Hospitalists
- House Bill 104
- Intermediate Sanctions Agreement
- Kentucky Health Benefit Exchange
- Kentucky House Bill 159
- Kentucky House Bill 217
- Licensed practical nurses (LPN)
- List of Excluded Individuals and Entities
- LLC v. Sutter
- Low-utilization payment adjustment ("LUPA")
- Meaningful use incentives
- Medicare Administrative Coordinators
- Medicare Benefit Policy Manual
- Network provider agreement
- Nonroutine medical supplies conversion factor (“NRS”)
- Nurse practitioners (NP)
- Office of the National Coordinator for Health Information Technology (“ONC”)
- Part A
- Part B
- Patient Autonomy
- Patient Privacy
- Payors
- Personal Health Information
- Physician Recruitment
- Physician shortages
- Provider Self Disclosure Protocol
- Quality reporting
- Registered nurses (RN)
- Residency Programs
- Self-Disclosure Protocol
- Senate Bill 39
- Senate Finance Committee Report
- State Medicaid Expansion
- Statement of Deficiency ("SOD")
- Trade Association Group Coverage
- Upcoding
- Abuse and Waste
- Center for Disease Control
- Compliance Programs
- Consumer Operated and Oriented Plan programs (“CO-OPS”)
- Critical Access Hospitals (“CAHs”)
- Essential Health Benefits (“EHBs”)
- Genetic Information Nondiscrimination Act ("GINA")
- Healthcare Information and Management Systems Society (HIMSS)
- Kentucky Cabinet for Health and Family Services
- Kentucky Health Care Co-Op
- Kentucky Health Cooperative (“KYHC”)
- Kentucky Primary Care Centers (“PCCs”)
- Managed Care Organizations (“MCOs”)
- Medicare Audit Improvement Act of 2012
- Occupational Safety and Health Administration (“OSHA”)
- Recovery Audit Contractors (“RAC”)
- Small Business Health Options Program (“SHOP”)
- Sunshine Act
- Employee Agreement
- Free Conference Committee Report
- Health Care Fraud and Abuse Control Program
- House Bill 1
- House Bill 4
- Kentucky “Pill Mill Bill”
- Pain Management Facilities
- Health Care Law
- Health Insurance
- Healthcare Regulation
McBrayer Blogs
Guidance on Mobile Medical Apps
Recently, the U.S. Food and Drug Administration (“FDA”) issued its much-anticipated final guidance for developers of mobile medical applications (“apps”). Apps run on mobile communication devices and can present unique problems not only to consumers, but also to providers who must walk a fine line between meaningful use requirements and HIPAA regulations regarding personal health information (“PHI”).
Mobile apps have the potential to transform the provider-patient relationship, as they can allow for diagnosis and interaction outside traditional health care settings. They also make it possible for patients to monitor and manage their own health care; the opportunity is literally within arm’s reach. There are now apps on the market that can diagnose abnormal heart rhythms, or transform a smart phone into a mobile ultrasound device.
Apps this powerful obviously carry significant risks if they do not operate properly. The FDA has decided how it will oversee this new technology; its focus will be on apps that:
1. are intended to be used as an accessory to a regulated medical device - for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture-archiving and communication system on a smartphone or tablet; or
2. transform a mobile platform into a regulated medical device, such as the ultrasound device mentioned previously.
The FDA will review mobile medical apps using the same regulatory standards and risk-based approach that is used for the review of all other medical devices.
The use of mobile technologies in healthcare has become a part of everyday business. That said, great caution should be exercised by providers when communicating with patients via any kind of mobile device. According to the Healthcare Information and Management Systems Society ("HIMSS"), over half of ePHI breaches are the result of theft, loss, or misuse of mobile devices. As more and more patients embrace apps for the management of their healthcare, providers should implement safeguards and strict policies to ensure that they are doing their part to protect ePHI.
Services may be performed by others.
This article does not constitute legal advice.
