Health Policy Outlook 2015Health Policy Outlook 2015

Health Tech NetJanuary 23, 2015Health Tech NetJanuary 23, 2015

2015: New Dynamics for Health Policy

• GOP House and Senate

• Lame Duck White House — But . . .

• Partisan and Bipartisan Opportunity

Health Policy’s Political Environment

• Reforming Health Reform

• Repeal? Replace? Refine?

• Hot Prospects: “Full-time,” medical device tax, individual mandate, IPAB, risk corridors

Select Health Issues

• HIT Regulatory Reform

• 21st Century Cures Initiative

• HIPAA Audits

• Patent “Reform”

HIT Regulatory Reform

• FDA regulation of HIT software

• FDASIA

• SOFTWARE Act/PROTECT Act

21st Century Cures Initiative

• Model of bipartisanship

• Input from stakeholders, Rs and Ds

• President’s Precision Medicine Initiative

HIPAA Audits

• Pilot project — 115 on-site audits

• HHS Office of Civil Rights goal: 350 covered-entity audits, 50 BA audits

• Focus on Privacy, Security, and Data Breach Rules

• OCR seeks “high-impact cases”

Patent Debate

• Patent “trolls” sending demand letters

• Labeled as “tort reform;” actually harsh restrictions on patent owners

• Judiciary, Commerce Committees

Stay Tuned!

• James Edwards, Ph.D.

• CEO, ELITE Strategic Services

• jedwards@ELITEStrategicServices.com