Health Policy Outlook 2015 Health Tech Net January 23, 2015 Health Tech Net January 23, 2015

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