WEBVTT 00:00:00.000 --> 00:00:01.980 MICHAEL ROSE: Just thanks a lot, Steve, 00:00:01.980 --> 00:00:03.510 for filling us in on this agenda. 00:00:03.510 --> 00:00:07.380 We thought it was important today to get on this agenda, 00:00:07.380 --> 00:00:10.140 because this group, the Healthcare Business Action 00:00:10.140 --> 00:00:13.840 Group, has been together for 18 months or so. 00:00:13.840 --> 00:00:16.484 And we're actually at a point now where 00:00:16.484 --> 00:00:18.450 we're developing some business requirements 00:00:18.450 --> 00:00:22.620 and moving it onto the Hardware and Software Action Group 00:00:22.620 --> 00:00:25.140 for some guidance. 00:00:25.140 --> 00:00:28.140 And some of our colleagues here that are going to talk today 00:00:28.140 --> 00:00:29.940 are going to get into some of the details 00:00:29.940 --> 00:00:33.540 around various areas we think we can use some research help. 00:00:33.540 --> 00:00:37.680 And clearly, as an industry, this 00:00:37.680 --> 00:00:40.980 is one area that we're starting to recognize where 00:00:40.980 --> 00:00:42.840 we do need to start reaching out and getting 00:00:42.840 --> 00:00:44.490 some direct help from you all. 00:00:44.490 --> 00:00:46.740 So we thank you for the opportunity today 00:00:46.740 --> 00:00:48.300 to talk to you. 00:00:48.300 --> 00:00:50.700 And hopefully, this will be an ongoing dialogue 00:00:50.700 --> 00:00:54.450 that we entertain with this group. 00:00:54.450 --> 00:00:57.360 Well, I though we'd just do a quick round of introductions. 00:00:57.360 --> 00:01:00.330 In addition to me, we have Bob Celeste from EPCglobal 00:01:00.330 --> 00:01:03.270 who's the director of the business action groups, 00:01:03.270 --> 00:01:04.860 and he's responsible for facilitation 00:01:04.860 --> 00:01:06.600 of the business action groups. 00:01:06.600 --> 00:01:09.570 Ted Ng, who's a director with McKesson, in spite 00:01:09.570 --> 00:01:11.063 of what it may say in the agenda. 00:01:11.063 --> 00:01:13.230 I don't think, Ted, you've gotten the promotion yet, 00:01:13.230 --> 00:01:16.050 but maybe next week to the vice president and board member. 00:01:16.050 --> 00:01:18.330 But hopefully, that'll happen next week, Ted. 00:01:18.330 --> 00:01:20.997 But it's nice to know, you go to Cambridge, you get a promotion. 00:01:20.997 --> 00:01:23.940 And Chuck Schramek, who is with EPCglobal now, 00:01:23.940 --> 00:01:26.190 but he's actually on loan from Johnson & Johnson. 00:01:26.190 --> 00:01:30.840 And about a year or so ago, J&J, we 00:01:30.840 --> 00:01:32.670 took we took a decision that we thought 00:01:32.670 --> 00:01:36.360 it was very important to help the development of industry 00:01:36.360 --> 00:01:36.910 standards. 00:01:36.910 --> 00:01:42.090 So we graciously let Chuck go to EPCglobal 00:01:42.090 --> 00:01:45.450 to help facilitate this development of standards 00:01:45.450 --> 00:01:46.870 in the health care industry. 00:01:46.870 --> 00:01:48.537 So as you see on the agenda here, 00:01:48.537 --> 00:01:50.370 Bob's going to give us an overview to what's 00:01:50.370 --> 00:01:53.220 been going on within the BAG the Healthcare & Life Science 00:01:53.220 --> 00:01:54.570 Business Action Group. 00:01:54.570 --> 00:01:57.477 Chuck is going to talk around item-level tagging. 00:01:57.477 --> 00:01:59.310 We had hoped to have Tom Pizzuto here today, 00:01:59.310 --> 00:02:02.730 who actually was our member from the Healthcare & Life Science 00:02:02.730 --> 00:02:05.880 group from Wyeth who was our chairman of that group. 00:02:05.880 --> 00:02:09.030 But Tom couldn't get up here because of business reasons. 00:02:09.030 --> 00:02:12.630 Ted's going to cover pedigree and the update 00:02:12.630 --> 00:02:14.190 around messaging around the pedigree. 00:02:14.190 --> 00:02:17.650 And then we'll certainly entertain any questions. 00:02:17.650 --> 00:02:20.767 So we'll all participate in the panel discussion. 00:02:20.767 --> 00:02:23.100 I just thought maybe I would touch on a couple of points 00:02:23.100 --> 00:02:24.300 here. 00:02:24.300 --> 00:02:26.280 Why are we doing this? 00:02:26.280 --> 00:02:29.100 It's not like fast-moving consumer goods, 00:02:29.100 --> 00:02:32.850 where you've got Walmart and Target saying you must 00:02:32.850 --> 00:02:36.807 and the Department of Defense coming out with mandates. 00:02:36.807 --> 00:02:38.640 The reason why we're very interested in this 00:02:38.640 --> 00:02:41.625 is because of some of the regulatory requirements that 00:02:41.625 --> 00:02:42.590 are starting to emerge. 00:02:42.590 --> 00:02:45.810 So we had the FDA back in 2004 that issued some guidelines 00:02:45.810 --> 00:02:49.320 around widespread adoption around RFID at the item level 00:02:49.320 --> 00:02:52.050 to begin tracking and tracing products. 00:02:52.050 --> 00:02:54.870 But the reality is, the issue that we're really dealing with 00:02:54.870 --> 00:02:56.280 is patient safety. 00:02:56.280 --> 00:03:00.780 This is an issue that this industry takes very to heart, 00:03:00.780 --> 00:03:02.580 because frankly, we're all affected by it. 00:03:02.580 --> 00:03:06.480 We want to ensure that the drugs and advices that you receive 00:03:06.480 --> 00:03:07.692 are genuine products. 00:03:07.692 --> 00:03:09.150 We don't want to go down the path-- 00:03:09.150 --> 00:03:12.690 and clearly you all understand the issues 00:03:12.690 --> 00:03:15.930 that we could encounter if counterfeit products are 00:03:15.930 --> 00:03:16.430 out there. 00:03:16.430 --> 00:03:19.360 So we're very, very concerned about this. 00:03:19.360 --> 00:03:22.020 So we're also responding to the movement 00:03:22.020 --> 00:03:24.780 within the states, where they're adopting what are 00:03:24.780 --> 00:03:26.820 called pedigree regulations. 00:03:26.820 --> 00:03:28.440 Right now, we've got a large number 00:03:28.440 --> 00:03:30.540 of states that are moving in this particular area, 00:03:30.540 --> 00:03:33.510 and this requires chain of custody tracking 00:03:33.510 --> 00:03:35.010 of the ownership of products. 00:03:35.010 --> 00:03:38.880 And as a result, both the FDA and-- 00:03:38.880 --> 00:03:40.830 well, the FDA particularly feels that this 00:03:40.830 --> 00:03:44.790 could be a key element to the track and trace of products. 00:03:44.790 --> 00:03:49.257 So the movement within the states and the FDA, we thought, 00:03:49.257 --> 00:03:51.840 was very important to be able to collaborate with them to show 00:03:51.840 --> 00:03:53.923 some movement in the industry with the development 00:03:53.923 --> 00:03:55.020 of our standards. 00:03:55.020 --> 00:03:57.503 But this is not just a US issue, and there 00:03:57.503 --> 00:03:59.920 are some other motivations that are going over in Europe-- 00:03:59.920 --> 00:04:01.602 particularly Belgium, Italy, and I 00:04:01.602 --> 00:04:03.810 know we've seen some movement in some other countries 00:04:03.810 --> 00:04:08.400 as well, where they're expecting serialization of items. 00:04:08.400 --> 00:04:11.760 Now, to be very clear, Belgium and Italy, 00:04:11.760 --> 00:04:14.130 they're not expecting RFID to be applied to a product. 00:04:14.130 --> 00:04:17.010 All they're asking for is serialization of that item-- 00:04:17.010 --> 00:04:19.079 mass serialization. 00:04:19.079 --> 00:04:22.170 And the movement within Europe is primarily 00:04:22.170 --> 00:04:24.630 driven because of pharmacy fraud. 00:04:24.630 --> 00:04:27.493 That's the reason why they're looking for serialization 00:04:27.493 --> 00:04:29.160 of items, because they want to know when 00:04:29.160 --> 00:04:31.740 a particular product is dispensed 00:04:31.740 --> 00:04:36.720 that gets reimbursed and only for one time, not 00:04:36.720 --> 00:04:37.740 multiple times. 00:04:37.740 --> 00:04:40.800 So these are some of the emerging regulatory drivers 00:04:40.800 --> 00:04:43.260 that we're starting to see within the pharmaceutical 00:04:43.260 --> 00:04:45.970 industry. 00:04:45.970 --> 00:04:49.050 This is a model that the FDA'S proposed, 00:04:49.050 --> 00:04:53.802 and we keep this in mind as we continue our discussions. 00:04:53.802 --> 00:04:55.260 And I think this is very important. 00:04:55.260 --> 00:04:57.760 It actually fits with a lot that was said earlier, 00:04:57.760 --> 00:05:00.360 by the other industries that presented today of, 00:05:00.360 --> 00:05:02.512 to really enable safe and secure supply chain, 00:05:02.512 --> 00:05:04.470 you need to be able to track and trace product. 00:05:04.470 --> 00:05:09.120 But you also need to be able to authenticate product as well. 00:05:09.120 --> 00:05:10.350 So in here-- 00:05:10.350 --> 00:05:11.740 I've got a bit of a build here. 00:05:11.740 --> 00:05:14.550 But to move us along, we think it's very important 00:05:14.550 --> 00:05:16.890 that authentication is needed, to be able to ensure 00:05:16.890 --> 00:05:18.900 that the product is genuine. 00:05:18.900 --> 00:05:21.090 That's when it becomes a foundational element 00:05:21.090 --> 00:05:23.070 for any track and trace system. 00:05:23.070 --> 00:05:26.940 Clearly, the pedigree allows us to be able to monitor and track 00:05:26.940 --> 00:05:29.560 that chain of custody, and changes as that product moves 00:05:29.560 --> 00:05:32.530 through the pipeline. 00:05:32.530 --> 00:05:34.440 So when you look at authentication, 00:05:34.440 --> 00:05:36.850 there's also a couple of different elements of that. 00:05:36.850 --> 00:05:39.450 We're looking at the product identity, 00:05:39.450 --> 00:05:41.700 but we're also looking at the physical characteristics 00:05:41.700 --> 00:05:43.330 of the product as well. 00:05:43.330 --> 00:05:45.900 So it's not simply does it have an ID number, because if you 00:05:45.900 --> 00:05:48.450 think of RFID at its basic element, 00:05:48.450 --> 00:05:50.307 and mass serialization at the basic element, 00:05:50.307 --> 00:05:52.890 we've been able to identify that package and the number that's 00:05:52.890 --> 00:05:54.720 been assigned to that package. 00:05:54.720 --> 00:05:57.150 What you don't know are about the contents of the package. 00:05:57.150 --> 00:05:59.410 Was it potentially tampered with, things like that. 00:05:59.410 --> 00:06:01.890 So that becomes gets us more into the areas 00:06:01.890 --> 00:06:03.875 of physical features. 00:06:03.875 --> 00:06:05.250 Certainly in the future, it would 00:06:05.250 --> 00:06:10.170 be nice to see if RFID could play a role as a method 00:06:10.170 --> 00:06:12.910 to ensure that the product has not been tampered with. 00:06:12.910 --> 00:06:17.730 But right now, in its current incarnation, it cannot do that. 00:06:17.730 --> 00:06:19.590 But we think over time, it would be 00:06:19.590 --> 00:06:21.600 nice to see what role RFID could play 00:06:21.600 --> 00:06:24.850 there to ensure that the product has not been tampered. 00:06:24.850 --> 00:06:27.660 On pedigree, we talk about track and trace. 00:06:27.660 --> 00:06:29.820 So where is the product and where is it headed, 00:06:29.820 --> 00:06:31.120 and where was the product. 00:06:31.120 --> 00:06:33.780 So it's the element of looking where it is, but then 00:06:33.780 --> 00:06:35.430 also being able to look backwards. 00:06:35.430 --> 00:06:39.300 And that's a very large issue for us. 00:06:39.300 --> 00:06:43.980 Our supply chain is not directly from manufacturer to retailer. 00:06:43.980 --> 00:06:45.900 There is a distributor in the middle there, 00:06:45.900 --> 00:06:48.820 and there can also be secondary distribution as well. 00:06:48.820 --> 00:06:50.790 So what you find is our supply chain 00:06:50.790 --> 00:06:53.670 can be a bit complicated when you start factoring in also 00:06:53.670 --> 00:06:54.660 returned goods. 00:06:54.660 --> 00:07:00.810 And the retail pharmacy may not ship those returned goods back 00:07:00.810 --> 00:07:03.250 to the distributor who originally distributed it 00:07:03.250 --> 00:07:03.750 to them. 00:07:03.750 --> 00:07:07.260 So you get into some very complicated situations 00:07:07.260 --> 00:07:10.290 to figure out where the product was and from whence it came. 00:07:10.290 --> 00:07:14.970 So as we conducted our work over the last 18 months, 00:07:14.970 --> 00:07:16.410 this is the base model that we've 00:07:16.410 --> 00:07:18.210 been working with and trying to develop 00:07:18.210 --> 00:07:22.980 some specifications for our industry based upon this model. 00:07:22.980 --> 00:07:25.520 So with this, I'm going to turn over to Bob, 00:07:25.520 --> 00:07:27.860 after an intro of what's driving industry. 00:07:27.860 --> 00:07:31.725 And Bob's going to talk about the actions within the HLS BAG 00:07:31.725 --> 00:07:33.977 and how we've organized our efforts and some 00:07:33.977 --> 00:07:35.060 of our current activities. 00:07:35.060 --> 00:07:35.600 So Bob? 00:07:39.058 --> 00:07:42.516 [APPLAUSE] 00:07:47.456 --> 00:07:50.040 BOB CELESTE: Thanks, Mike. 00:07:50.040 --> 00:07:53.700 So I just wanted to give an overview of why 00:07:53.700 --> 00:07:55.650 health care is looking at RFID. 00:07:55.650 --> 00:07:59.050 Basically, it's to form the safe and secure supply chain. 00:07:59.050 --> 00:08:01.680 So you're seeing things up here about item-level tagging, 00:08:01.680 --> 00:08:04.980 electronic pedigree, track and trace, product authentication. 00:08:04.980 --> 00:08:07.500 And the group actually has a very regimented way 00:08:07.500 --> 00:08:08.670 of going through this-- 00:08:08.670 --> 00:08:11.250 of developing the capabilities that they'd 00:08:11.250 --> 00:08:14.340 like-- the scenarios, the use cases, and then any 00:08:14.340 --> 00:08:16.420 variants on those use cases. 00:08:16.420 --> 00:08:19.710 Our first capability that we started with 00:08:19.710 --> 00:08:21.480 was pedigree management. 00:08:21.480 --> 00:08:23.880 And as Mike talked about, that was primarily 00:08:23.880 --> 00:08:26.190 driven through the regulations that the industry had. 00:08:29.018 --> 00:08:31.560 So I'm actually going to spend most of my time on this slide, 00:08:31.560 --> 00:08:34.020 and I'll give you a second to soak it in. 00:08:34.020 --> 00:08:36.780 We're hoping that the Auto-ID members in the audience 00:08:36.780 --> 00:08:38.789 will take a look at some of these checkmarks. 00:08:38.789 --> 00:08:42.780 These are areas that we feel that Auto-ID can help us out 00:08:42.780 --> 00:08:44.340 with. 00:08:44.340 --> 00:08:47.100 Basically, this slide is broken into a few areas. 00:08:47.100 --> 00:08:50.342 The blue areas is our structure. 00:08:50.342 --> 00:08:52.800 So for each one of these blue areas, there's the co-chairs, 00:08:52.800 --> 00:08:56.200 and they all report up into the tri-chair area. 00:08:56.200 --> 00:08:59.950 So you see the strategy work group, information, technology, 00:08:59.950 --> 00:09:02.940 R&D, and process work groups. 00:09:02.940 --> 00:09:05.190 Last year, when we looked at things 00:09:05.190 --> 00:09:08.760 like pedigree management, one of the things we realized was-- 00:09:08.760 --> 00:09:12.120 and we've talked about a lot today with security, 00:09:12.120 --> 00:09:15.210 and the requirements are pretty clear. 00:09:15.210 --> 00:09:18.900 The people in the supply chain, and sometimes customers, 00:09:18.900 --> 00:09:21.780 would need to read and write the tags. 00:09:21.780 --> 00:09:23.850 The bad guys don't need to do that, 00:09:23.850 --> 00:09:26.910 and that's our requirement. 00:09:26.910 --> 00:09:28.950 To that point, because we don't have 00:09:28.950 --> 00:09:33.690 a very simple, cost-effective, easy mechanism for securing 00:09:33.690 --> 00:09:35.910 the tags and the information in the supply chain, 00:09:35.910 --> 00:09:38.440 there's a number of areas you see here where 00:09:38.440 --> 00:09:40.230 we're looking at security. 00:09:40.230 --> 00:09:43.620 In the areas of item-level tagging, how to physically 00:09:43.620 --> 00:09:44.610 secure a tag? 00:09:44.610 --> 00:09:47.340 In the areas of serialization, how do we 00:09:47.340 --> 00:09:49.680 secure the number on a tag? 00:09:49.680 --> 00:09:53.160 In the areas of decommissioning, how do we ensure that a tag 00:09:53.160 --> 00:09:56.190 does not get removed from a discarded bottle and re-enter 00:09:56.190 --> 00:09:57.180 the supply chain-- 00:09:57.180 --> 00:09:58.180 things like that. 00:09:58.180 --> 00:10:00.510 So security actually has broad ramifications 00:10:00.510 --> 00:10:04.110 as far as the areas that we're working on. 00:10:04.110 --> 00:10:05.760 Some of the areas that we'll be working 00:10:05.760 --> 00:10:09.690 on in 2006 that are interesting are track and trace. 00:10:09.690 --> 00:10:14.430 And I want to make a difference in your mind between what track 00:10:14.430 --> 00:10:16.830 and trace and what pedigree is. 00:10:16.830 --> 00:10:19.500 So pedigree-- and I think Chuck actually coined this phrase 00:10:19.500 --> 00:10:20.058 today. 00:10:20.058 --> 00:10:21.600 With pedigree, if you think about it, 00:10:21.600 --> 00:10:25.350 it's a business to regulate our message. 00:10:25.350 --> 00:10:27.720 Pedigree can be started by paper. 00:10:27.720 --> 00:10:30.360 They can be started through a EDI transaction 00:10:30.360 --> 00:10:32.610 or through an XML transaction. 00:10:32.610 --> 00:10:36.180 Not easily courierable for an industry. 00:10:36.180 --> 00:10:38.700 So we're also looking this year at the track and trace, 00:10:38.700 --> 00:10:41.370 the vocabulary that this industry will use, 00:10:41.370 --> 00:10:43.410 and the understanding they'll have at a business 00:10:43.410 --> 00:10:47.520 level of what all of the events mean when you move product 00:10:47.520 --> 00:10:50.680 with RFID tags on them. 00:10:50.680 --> 00:10:53.460 The other areas I'll point out that will be new is-- 00:10:53.460 --> 00:10:55.440 and we originally saw these as variants, 00:10:55.440 --> 00:10:57.960 so we'll be doing a little bit of a GAAP 00:10:57.960 --> 00:11:00.700 analysis between the requirements we have today 00:11:00.700 --> 00:11:04.570 and when we bring companies that focus in these areas. 00:11:04.570 --> 00:11:07.290 And those areas like cold chain, medical devices, 00:11:07.290 --> 00:11:11.040 which will start up soon, and biologics, and how they affect 00:11:11.040 --> 00:11:14.220 and how they add requirements to our pack. 00:11:14.220 --> 00:11:16.830 So I think I'm maybe done with that. 00:11:16.830 --> 00:11:18.640 That was my one slide. 00:11:18.640 --> 00:11:20.182 So we'll give Chuck the floor. 00:11:26.565 --> 00:11:30.002 [APPLAUSE] 00:11:37.367 --> 00:11:39.540 CHUCK SCHRAMEK: OK, I'm here again 00:11:39.540 --> 00:11:41.550 subbing for Tom Pizutto with regard 00:11:41.550 --> 00:11:43.050 to item level tagging in the work 00:11:43.050 --> 00:11:47.010 that that work group has done for the Healthcare & Life 00:11:47.010 --> 00:11:49.350 Sciences BAG. 00:11:49.350 --> 00:11:53.820 This group consisted of a series of about, 00:11:53.820 --> 00:11:56.400 I guess, 32 individuals that were part of the Item-Level 00:11:56.400 --> 00:11:58.320 Tagging work group. 00:11:58.320 --> 00:12:03.330 10 were from Fast Moving Consumer Goods, 00:12:03.330 --> 00:12:05.970 10 were from Healthcare and Life Sciences, 00:12:05.970 --> 00:12:11.160 and 10 were from the Hardware Action Group within EPCglobal. 00:12:11.160 --> 00:12:16.500 In addition to that, we had Dan Engels from Auto-ID center 00:12:16.500 --> 00:12:17.800 here working with us. 00:12:17.800 --> 00:12:21.540 And we also had an individual from the Architectural Review 00:12:21.540 --> 00:12:23.880 Council within EPCglobal. 00:12:23.880 --> 00:12:28.080 So that group was pulled together from the three BAGs 00:12:28.080 --> 00:12:30.870 to represent those BAGs and their interests with respect 00:12:30.870 --> 00:12:35.850 to turning requirements into solutions, or at least 00:12:35.850 --> 00:12:40.230 into understandable requirements for the Hardware Action Group 00:12:40.230 --> 00:12:42.660 to act upon. 00:12:42.660 --> 00:12:45.150 The objectives that we had before us-- 00:12:45.150 --> 00:12:48.270 again, because we were basically business action groups, 00:12:48.270 --> 00:12:51.840 was to really define the business scenarios 00:12:51.840 --> 00:12:54.390 and requirements that would drive 00:12:54.390 --> 00:13:01.980 the way we intended to deploy and adopt RFID technology. 00:13:01.980 --> 00:13:03.780 We started out with business scenarios, 00:13:03.780 --> 00:13:06.152 again focusing on item level. 00:13:06.152 --> 00:13:09.240 Case and pallet had been pretty well covered 00:13:09.240 --> 00:13:12.540 in a fine fashion from FMCG. 00:13:12.540 --> 00:13:14.580 Item level had not. 00:13:14.580 --> 00:13:18.480 It was paramount importance to Healthcare & Life Sciences. 00:13:18.480 --> 00:13:20.550 And yet, it was also a significant importance 00:13:20.550 --> 00:13:24.870 to both FMCG and DoD. 00:13:24.870 --> 00:13:28.380 Went into tremendous detail addressing the operating 00:13:28.380 --> 00:13:33.660 environments in which item-level tagging would have to perform. 00:13:33.660 --> 00:13:39.060 Min/max read and write ranges were critical to us, 00:13:39.060 --> 00:13:41.910 because it was a very different set of scenarios 00:13:41.910 --> 00:13:44.010 from pallet and case. 00:13:44.010 --> 00:13:47.820 Security requirements, which you've heard all day long, 00:13:47.820 --> 00:13:51.550 were as important for us as they have been for all of you, 00:13:51.550 --> 00:13:54.090 both in the other industry presentations, as well 00:13:54.090 --> 00:13:57.720 as the Auto-ID Lab's work that you've been doing to date. 00:14:00.600 --> 00:14:04.950 Privacy features, critical to Healthcare & Life Sciences. 00:14:04.950 --> 00:14:07.590 Again, we have significant concerns there that, 00:14:07.590 --> 00:14:09.750 unless we educate the public well enough 00:14:09.750 --> 00:14:15.030 to understand the value of this technology and its use 00:14:15.030 --> 00:14:16.950 in their best interests, it will be 00:14:16.950 --> 00:14:19.590 a challenge getting adoption. 00:14:19.590 --> 00:14:21.900 We have a number of products, controlled substances 00:14:21.900 --> 00:14:27.700 that, in pharma industries, we have to move out to customers. 00:14:27.700 --> 00:14:31.440 These need to be shielded and secured so that others do not 00:14:31.440 --> 00:14:34.450 know what is being sent. 00:14:34.450 --> 00:14:36.600 We don't want these tags going out live 00:14:36.600 --> 00:14:41.460 to customers and consumers, because they in turn are 00:14:41.460 --> 00:14:48.390 paranoid about knowledge of medication consumption being 00:14:48.390 --> 00:14:51.940 made available to those around them. 00:14:51.940 --> 00:14:53.970 And lastly, memory features-- 00:14:53.970 --> 00:14:57.270 this area is how do we want to use the memory that 00:14:57.270 --> 00:15:02.700 will be on the chip in the most efficient and effective way? 00:15:02.700 --> 00:15:05.130 The progress we've made to date-- 00:15:05.130 --> 00:15:07.860 and again, this group has been working, 00:15:07.860 --> 00:15:11.670 I guess, since about late July of 2005. 00:15:11.670 --> 00:15:16.470 We delivered a series of item-level requirements 00:15:16.470 --> 00:15:17.880 to that group. 00:15:17.880 --> 00:15:20.460 It was about 32 pages worth of requirements, 00:15:20.460 --> 00:15:22.680 spanning both all three-- 00:15:22.680 --> 00:15:28.530 HLS, FMCG, and DoD, as well as 60 business scenarios 00:15:28.530 --> 00:15:32.070 that we felt well demonstrated the way 00:15:32.070 --> 00:15:36.680 this technology needed to work for those three groups. 00:15:36.680 --> 00:15:40.440 On January 16 and 17, we narrowed that down. 00:15:40.440 --> 00:15:43.560 We winnowed all the way down to about seven critical scenarios, 00:15:43.560 --> 00:15:47.370 that it was the intention of the Hardware Action Group 00:15:47.370 --> 00:15:49.980 and the vendor community supporting Hardware Action 00:15:49.980 --> 00:15:54.630 Group to do demonstrations of those seven scenarios. 00:15:54.630 --> 00:15:58.380 And those seven scenarios are the ones listed here. 00:15:58.380 --> 00:16:00.690 They span, again, the three Business Action 00:16:00.690 --> 00:16:02.970 Groups I'm here to represent. 00:16:02.970 --> 00:16:08.280 Hanging garments on mobile metal hanger racks 00:16:08.280 --> 00:16:13.560 creates a real dilemma for the apparel industry 00:16:13.560 --> 00:16:16.660 from a reader perspective, a tenant perspective. 00:16:16.660 --> 00:16:18.420 A dock door portal, same thing. 00:16:18.420 --> 00:16:23.640 If you look across all three of those groups, 00:16:23.640 --> 00:16:26.310 we need to be able to read accurately. 00:16:26.310 --> 00:16:29.940 And particularly when you get to the health care side, 00:16:29.940 --> 00:16:33.150 we are not comfortable with 99% reads. 00:16:33.150 --> 00:16:36.690 We really do need 100% reads. 00:16:36.690 --> 00:16:39.510 Apparel point of sale, again, was a scenario 00:16:39.510 --> 00:16:41.670 we picked, because it represented 00:16:41.670 --> 00:16:45.630 one of the more challenging point of sale scenarios 00:16:45.630 --> 00:16:51.750 that needed to be shown to be effective. 00:16:51.750 --> 00:16:56.430 DVDs in adjacent shelf slots, in that particular scenario, 00:16:56.430 --> 00:17:01.830 again, represent close packing of a product on metal shelves-- 00:17:01.830 --> 00:17:06.510 a dense reader scenario, more or less. 00:17:06.510 --> 00:17:09.240 Vials and ampoules in a case-- 00:17:09.240 --> 00:17:11.790 here again, this was a read scenario. 00:17:11.790 --> 00:17:15.660 And for us, this represents probably one of the smallest 00:17:15.660 --> 00:17:18.630 products that we'll be tagging, and it 00:17:18.630 --> 00:17:21.210 represented a challenge for us both on a read and write 00:17:21.210 --> 00:17:23.940 perspective. 00:17:23.940 --> 00:17:29.580 The speed at which these move across the packaging lines 00:17:29.580 --> 00:17:33.504 is of concern, so we need real accuracy there. 00:17:33.504 --> 00:17:35.724 AUDIENCE: [INAUDIBLE]. 00:17:35.724 --> 00:17:39.680 CHUCK SCHRAMEK: Exactly, and probably the most challenging 00:17:39.680 --> 00:17:43.850 scenario that the Hague faces, in the work ahead of them, 00:17:43.850 --> 00:17:47.660 is that of the retail form a mixed tote scenario. 00:17:47.660 --> 00:17:51.803 This is where the wholesalers will put together-- 00:17:51.803 --> 00:17:53.720 particularly the wholesalers will put together 00:17:53.720 --> 00:17:56.720 a code of product that could represent 00:17:56.720 --> 00:18:01.160 a dozen or better manufacturers' products, 00:18:01.160 --> 00:18:04.610 all tagged differently, all kinds of different products 00:18:04.610 --> 00:18:09.290 of all sorts of form factors, of materials, 00:18:09.290 --> 00:18:15.710 and of contents, all together the orientation of antennas, 00:18:15.710 --> 00:18:17.600 its random orientation. 00:18:17.600 --> 00:18:20.180 So it's going to be truly a challenge for them 00:18:20.180 --> 00:18:22.350 to demonstrate that one. 00:18:22.350 --> 00:18:24.920 And then the last one, the vial and ampoule 00:18:24.920 --> 00:18:27.320 write scenario was the only write scenario 00:18:27.320 --> 00:18:30.735 that we did including this, because we felt that this was 00:18:30.735 --> 00:18:34.910 the one that represented things very close together, 00:18:34.910 --> 00:18:38.730 very small form factor, going at a particular pace. 00:18:42.020 --> 00:18:44.840 The areas of central focus and concern for us 00:18:44.840 --> 00:18:47.120 in these demonstrations that are coming up 00:18:47.120 --> 00:18:50.780 are really to look at performance considerations. 00:18:50.780 --> 00:18:53.060 And again, this is the operation of the tags, 00:18:53.060 --> 00:18:55.970 operations between tags and readers, 00:18:55.970 --> 00:18:59.630 operations of fixed readers, and the presence of mobile readers. 00:18:59.630 --> 00:19:01.910 Again, this is in the retail end of the supply chain 00:19:01.910 --> 00:19:03.740 that we're addressing. 00:19:03.740 --> 00:19:09.020 And lastly, operation in dense reader environments. 00:19:09.020 --> 00:19:12.230 There again, inventory tags that are 00:19:12.230 --> 00:19:16.310 occurring in the retail setting, either in the store 00:19:16.310 --> 00:19:20.420 or in the back rooms, with lots of readers, lots of antennas, 00:19:20.420 --> 00:19:22.460 tons of products. 00:19:22.460 --> 00:19:27.290 Security considerations-- here, as you've heard all day long, 00:19:27.290 --> 00:19:30.530 the interest here is in manageable, affordable, 00:19:30.530 --> 00:19:35.270 and non-intrusive security solutions. 00:19:35.270 --> 00:19:41.600 We just can't afford the cost of the detail or the latency 00:19:41.600 --> 00:19:46.820 that might be introduced with certain types of encryption 00:19:46.820 --> 00:19:48.150 and decryption requirements. 00:19:48.150 --> 00:19:49.850 So this is an area that we really 00:19:49.850 --> 00:19:53.570 would like to work very closely with the labs on. 00:19:58.010 --> 00:20:02.780 Memory read/write locking-- this is hopefully a solution for us 00:20:02.780 --> 00:20:05.420 as we move forward with respect to shielding 00:20:05.420 --> 00:20:08.210 certain pieces of information that we 00:20:08.210 --> 00:20:13.190 need to shield as the products move through the supply chain, 00:20:13.190 --> 00:20:15.800 yet make them visible at different points in the supply 00:20:15.800 --> 00:20:18.110 chain for efficiency and effectiveness 00:20:18.110 --> 00:20:20.810 of those operations. 00:20:20.810 --> 00:20:23.150 And lastly, decommissioning of tags-- 00:20:23.150 --> 00:20:25.980 Bob mentioned that earlier in the discussion. 00:20:25.980 --> 00:20:28.820 This is an area that, again, for the Healthcare and Life 00:20:28.820 --> 00:20:30.740 Sciences group is of particular concern, 00:20:30.740 --> 00:20:33.980 because we want to make sure that we have 00:20:33.980 --> 00:20:37.520 a way of either killing or partially killing tags 00:20:37.520 --> 00:20:41.840 as it goes out to the consuming population, 00:20:41.840 --> 00:20:44.750 and possibly bringing it back if we want at a later date, 00:20:44.750 --> 00:20:47.540 when we want to use it in a much more progressive fashion. 00:20:51.887 --> 00:20:54.900 The dense reader environment considerations-- here, 00:20:54.900 --> 00:20:59.150 we're having trouble, because every one of those scenarios 00:20:59.150 --> 00:21:02.960 is unique to the business or the operation that's 00:21:02.960 --> 00:21:06.620 performing them, and how we're going to replicate something 00:21:06.620 --> 00:21:07.190 like that. 00:21:07.190 --> 00:21:11.540 And our task coming up is going to be a real challenge. 00:21:11.540 --> 00:21:13.820 But we do have dense reader scenarios 00:21:13.820 --> 00:21:16.790 in these various locations throughout the supply chain, 00:21:16.790 --> 00:21:19.730 either at the dock doors, at the racking and the distribution 00:21:19.730 --> 00:21:22.700 centers, at the shelves in the retail store, 00:21:22.700 --> 00:21:25.220 and even at customer checkout. 00:21:25.220 --> 00:21:30.320 So it's a concern for us in terms of interference. 00:21:30.320 --> 00:21:34.070 And lastly are the mobile readers, 00:21:34.070 --> 00:21:36.720 entering the field of stationary readers. 00:21:36.720 --> 00:21:39.830 Again, the Nokia phone example of being 00:21:39.830 --> 00:21:46.550 able to go in and to read a tag, our concerns were, well, 00:21:46.550 --> 00:21:50.720 is this really going to impact the intelligent shelf readers 00:21:50.720 --> 00:21:52.950 that may be in place or not. 00:21:52.950 --> 00:21:54.800 And it seems like from the research 00:21:54.800 --> 00:21:58.310 that's been done today by Auto-ID Labs 00:21:58.310 --> 00:22:00.500 here, that's one that we're not going to have 00:22:00.500 --> 00:22:03.630 to worry too much about. 00:22:03.630 --> 00:22:10.380 Now, I'm not going to go into detail on these. 00:22:10.380 --> 00:22:14.030 But these are just to give you an example 00:22:14.030 --> 00:22:18.260 of the depth of detail and the comprehensiveness in which we 00:22:18.260 --> 00:22:22.550 defined our business scenarios to capture the operating 00:22:22.550 --> 00:22:25.520 environments in which these tanks would have to work. 00:22:25.520 --> 00:22:29.390 We measured everything from where in the scenario 00:22:29.390 --> 00:22:32.930 it would occur to the number of tags 00:22:32.930 --> 00:22:35.390 that would have to be read at that particular point, 00:22:35.390 --> 00:22:40.790 the interrogation region that the readers would be impacted 00:22:40.790 --> 00:22:44.420 by, the tag antenna sizes and the variety of those tag 00:22:44.420 --> 00:22:50.330 antenna sizes, maximum read ranges, maximum tag velocity-- 00:22:50.330 --> 00:22:53.360 or in cases when they're stationary, how long are 00:22:53.360 --> 00:22:58.550 they stationary to allow a read. 00:22:58.550 --> 00:23:01.160 The reader reliability-- again, this 00:23:01.160 --> 00:23:06.200 is something that we feel very strongly about being 00:23:06.200 --> 00:23:08.790 as close to 100% as possible. 00:23:08.790 --> 00:23:13.640 And then the last one were notes on the materials and make-ups 00:23:13.640 --> 00:23:15.770 of what these scenarios were all about. 00:23:19.400 --> 00:23:24.890 A good example, again, going back to the retail pharma tote, 00:23:24.890 --> 00:23:27.290 here again, you're looking at liquids, blister packs, 00:23:27.290 --> 00:23:35.660 tablets, syringes, full metal packages, all in a tote 00:23:35.660 --> 00:23:40.800 to be read with random oriented placement in that tote. 00:23:40.800 --> 00:23:45.750 So these are very, very challenging demonstrations. 00:23:45.750 --> 00:23:51.380 We know, hopefully, that most of it will be successful, 00:23:51.380 --> 00:23:54.590 and we'll move forward with getting solutions. 00:23:54.590 --> 00:23:57.337 And where we are now is we're proceeding 00:23:57.337 --> 00:23:59.420 in this second phase, which is turning all of this 00:23:59.420 --> 00:24:02.210 over to the Hague for them to take on. 00:24:02.210 --> 00:24:04.490 There is a little wrap-up work that's 00:24:04.490 --> 00:24:06.170 still expected of our group, and that's 00:24:06.170 --> 00:24:10.260 to get a better sense of what the hospital demands are. 00:24:10.260 --> 00:24:14.330 Unfortunately, today, we haven't had hospital representation 00:24:14.330 --> 00:24:17.600 as directly and strongly as what we've 00:24:17.600 --> 00:24:20.645 needed in the HLS community. 00:24:20.645 --> 00:24:22.520 But we do need to get more information there, 00:24:22.520 --> 00:24:25.520 because that represents a possible frequency 00:24:25.520 --> 00:24:30.360 issue for us, and likewise more complexity. 00:24:30.360 --> 00:24:33.380 So the Hague is going to confirm that the technology 00:24:33.380 --> 00:24:35.070 vendors that are going to work with them 00:24:35.070 --> 00:24:37.220 in these demonstrations, which they think 00:24:37.220 --> 00:24:40.220 will be somewhere between six and 12 companies 00:24:40.220 --> 00:24:41.482 working with us. 00:24:41.482 --> 00:24:43.190 We want to make sure they cover the seven 00:24:43.190 --> 00:24:45.860 scenarios in an equal fashion, so they don't all 00:24:45.860 --> 00:24:48.830 go after scenario one and five, and the others 00:24:48.830 --> 00:24:50.243 don't get addressed. 00:24:50.243 --> 00:24:52.160 That's going to be the challenge for the Hague 00:24:52.160 --> 00:24:54.170 to make sure they work that out. 00:24:54.170 --> 00:24:59.750 They're going to do the work between February and March 22, 00:24:59.750 --> 00:25:01.610 at which time, these demonstrations 00:25:01.610 --> 00:25:05.560 are going to be provided back to the three business action 00:25:05.560 --> 00:25:06.060 groups-- 00:25:06.060 --> 00:25:08.750 HLS, FMCG, and DoD. 00:25:08.750 --> 00:25:13.340 And then we will see where we go from there in terms of what 00:25:13.340 --> 00:25:15.120 they can do and what they can't. 00:25:15.120 --> 00:25:18.950 So out of that, we expect a lot of opportunities 00:25:18.950 --> 00:25:24.080 to come back to you, and ask for assistance in drilling 00:25:24.080 --> 00:25:26.420 down on how we can turn something 00:25:26.420 --> 00:25:29.000 that doesn't look like it can work today into something 00:25:29.000 --> 00:25:33.680 that can six or nine months, a year, year and a half out. 00:25:33.680 --> 00:25:35.409 OK. 00:25:35.409 --> 00:25:38.860 [APPLAUSE] 00:25:48.227 --> 00:25:49.890 TED NG: Hi, I'm Ted. 00:25:49.890 --> 00:25:52.400 I'm going to try to go through, with you guys, what 00:25:52.400 --> 00:25:56.600 we've done in the BAG for the pedigree side of the business. 00:25:56.600 --> 00:26:02.270 Again, Mike opened up with very leading drivers of what's 00:26:02.270 --> 00:26:03.200 causing us to do this. 00:26:03.200 --> 00:26:06.680 And really, the driver is not pedigree, 00:26:06.680 --> 00:26:09.960 but the driver is really patient safety in health care. 00:26:09.960 --> 00:26:12.710 OK, again, our lightening rod for us 00:26:12.710 --> 00:26:14.390 to move forward in the pedigree space 00:26:14.390 --> 00:26:16.550 was caused by the FDA report that 00:26:16.550 --> 00:26:20.750 was issued in February of 2004. 00:26:20.750 --> 00:26:23.682 So it appears that we do have a counterfeit problem, 00:26:23.682 --> 00:26:25.640 and how are we going to deal with that problem? 00:26:25.640 --> 00:26:27.650 And the report indicated that the best way 00:26:27.650 --> 00:26:31.420 to do that was to use RFID-based systems. 00:26:31.420 --> 00:26:33.800 So I think you guys have seen these products. 00:26:33.800 --> 00:26:36.098 One side is the good product. 00:26:36.098 --> 00:26:36.890 On the right side-- 00:26:36.890 --> 00:26:39.260 I mean, left or right side, depending on the product, 00:26:39.260 --> 00:26:41.090 is showing you the good [INAUDIBLE] 00:26:41.090 --> 00:26:42.230 and the bad products. 00:26:42.230 --> 00:26:44.063 So how are you going to tell the difference? 00:26:44.063 --> 00:26:46.190 So they're saying RFID is the way to go. 00:26:48.740 --> 00:26:55.040 The problem is we have too many cooks in the kitchen for us. 00:26:55.040 --> 00:26:56.080 We would love to comply. 00:26:56.080 --> 00:26:57.470 I think the industry wants to comply. 00:26:57.470 --> 00:26:59.390 I think it's the right thing to do for us, the right thing 00:26:59.390 --> 00:27:00.680 to do for the nation. 00:27:00.680 --> 00:27:06.440 But if you look at this, 30-plus states 00:27:06.440 --> 00:27:08.060 have written pedigree laws now. 00:27:08.060 --> 00:27:10.890 And I represent McKesson, and McKesson's 00:27:10.890 --> 00:27:12.890 a wholesale distributor of pharmaceutical drugs. 00:27:12.890 --> 00:27:15.710 We cannot afford to write systems for 30 different 00:27:15.710 --> 00:27:16.940 states, basically. 00:27:16.940 --> 00:27:19.970 So we really need to have a consistent model. 00:27:19.970 --> 00:27:22.590 The model that Mike showed would be great to have. 00:27:22.590 --> 00:27:24.930 But unfortunately, Florida, the first one 00:27:24.930 --> 00:27:26.810 that's coming up for us, which we 00:27:26.810 --> 00:27:29.210 put a lot of effort behind July 1st of 2006 00:27:29.210 --> 00:27:32.390 indicated that we have to be in compliance to their model 00:27:32.390 --> 00:27:36.230 first, and then followed by January 1st of 2007 00:27:36.230 --> 00:27:37.160 is California. 00:27:37.160 --> 00:27:39.530 And then there's various laws already in place, 00:27:39.530 --> 00:27:42.320 like in regulatory process like Nevada, 00:27:42.320 --> 00:27:45.680 like Texas, already in progress and writing regulations that 00:27:45.680 --> 00:27:48.140 may interfere with what has already 00:27:48.140 --> 00:27:50.150 been proposed by Florida. 00:27:50.150 --> 00:27:52.320 So the real benefit for us, so to speak, 00:27:52.320 --> 00:27:56.130 is that the models have been proposed by the other 29, 00:27:56.130 --> 00:28:00.170 30-plus states here differs significantly from Florida. 00:28:00.170 --> 00:28:03.900 So there might be some consolidation, 00:28:03.900 --> 00:28:06.020 so to speak, hopefully by the models. 00:28:06.020 --> 00:28:09.500 And what we're looking for is some federal interaction here 00:28:09.500 --> 00:28:11.870 that will allow us to do that. 00:28:11.870 --> 00:28:15.080 So really, I'll talk a little bit about the solution 00:28:15.080 --> 00:28:18.350 is identification and tracking. 00:28:18.350 --> 00:28:19.550 But how do you do that? 00:28:19.550 --> 00:28:21.260 I have not heard anything today that 00:28:21.260 --> 00:28:24.470 tells me that says that we need to do the entire supply 00:28:24.470 --> 00:28:26.440 chain in all products in the supply chain. 00:28:26.440 --> 00:28:28.190 That's not what we need to have done here. 00:28:28.190 --> 00:28:29.540 We've got to do some type of-- 00:28:29.540 --> 00:28:34.190 I don't think there's sufficient RFID capacity in the industry 00:28:34.190 --> 00:28:37.580 to solve and meet all of the demand necessary to enable 00:28:37.580 --> 00:28:40.480 the entire supply chain of pharmaceutical products. 00:28:40.480 --> 00:28:42.920 So there's got to be some approach, some thinking, that 00:28:42.920 --> 00:28:46.820 says that what's a rational adoption approach here? 00:28:46.820 --> 00:28:48.560 Is it high demand guys only? 00:28:48.560 --> 00:28:50.150 Is it the top 100? 00:28:50.150 --> 00:28:53.000 Is it the guys that are most counterfeited? 00:28:53.000 --> 00:28:56.480 So we need help and need some guidance here. 00:28:56.480 --> 00:28:59.150 But again, we're forced by the Florida pedigree law 00:28:59.150 --> 00:29:01.520 to enable the whole supply chain. 00:29:01.520 --> 00:29:02.570 But if you look at-- 00:29:02.570 --> 00:29:05.270 well, going into what Florida is all about, 00:29:05.270 --> 00:29:07.640 that model is fundamentally flawed, 00:29:07.640 --> 00:29:11.420 in the way we would think about a pure chain of custody 00:29:11.420 --> 00:29:14.100 and a pedigree model. 00:29:14.100 --> 00:29:17.520 So the Florida pedigree model says it's not the data element, 00:29:17.520 --> 00:29:18.020 so to speak. 00:29:18.020 --> 00:29:19.890 It's what you're trying to accomplish here. 00:29:19.890 --> 00:29:23.765 And we need this basic stuff. 00:29:23.765 --> 00:29:25.640 And they don't even talk about serialization. 00:29:25.640 --> 00:29:27.980 Obviously, when you counterfeit product 00:29:27.980 --> 00:29:30.560 at an item level, or a bottle level, 00:29:30.560 --> 00:29:34.040 and they're looking at tracking only a lot and expiration date, 00:29:34.040 --> 00:29:36.810 so to speak. 00:29:36.810 --> 00:29:38.227 So there was other industry groups 00:29:38.227 --> 00:29:39.977 that have come together-- not just states. 00:29:39.977 --> 00:29:41.690 I didn't show you the whole picture here. 00:29:41.690 --> 00:29:43.400 There has been NABP, then there's 00:29:43.400 --> 00:29:46.460 other groups in uniform. 00:29:46.460 --> 00:29:47.960 There's our uniform pedigree council 00:29:47.960 --> 00:29:50.210 that we put together by different industry groups 00:29:50.210 --> 00:29:52.700 representing various factions here. 00:29:52.700 --> 00:29:54.827 But they came up with a different set 00:29:54.827 --> 00:29:57.410 of data elements associated with what should be in a pedigree. 00:30:00.140 --> 00:30:04.180 So really, what they did was in those groups 00:30:04.180 --> 00:30:06.160 was define quote, "the data elements." 00:30:06.160 --> 00:30:09.310 Obviously, data elements are of value. 00:30:09.310 --> 00:30:11.570 Because I'm an IT guy, I work with data elements. 00:30:11.570 --> 00:30:13.540 But what's more important? 00:30:13.540 --> 00:30:16.150 What's the process associated with that definition 00:30:16.150 --> 00:30:18.790 of what a pedigree is? 00:30:18.790 --> 00:30:20.140 Who updates the data? 00:30:20.140 --> 00:30:23.530 Who says what data should be there once you update it? 00:30:23.530 --> 00:30:25.360 How do I share the information. 00:30:25.360 --> 00:30:27.610 And then from the process side, where does it 00:30:27.610 --> 00:30:30.940 start, who is responsible, who will enforce? 00:30:30.940 --> 00:30:34.760 Again, we talked about what is authentication here. 00:30:34.760 --> 00:30:35.750 It's not just a number. 00:30:35.750 --> 00:30:37.720 It's also the over and covert measures associated 00:30:37.720 --> 00:30:39.178 with it, and the linking of the two 00:30:39.178 --> 00:30:41.700 sides of the pedigree model, with a right side 00:30:41.700 --> 00:30:44.560 and a left side, in a logical data model. 00:30:44.560 --> 00:30:45.940 So who pays for the system, which 00:30:45.940 --> 00:30:47.500 is even a better question. 00:30:47.500 --> 00:30:49.080 If regulatory mandates this stuff, 00:30:49.080 --> 00:30:51.580 obviously, there's going to be a huge increase in cost here. 00:30:54.250 --> 00:30:57.160 And McKesson deals with literally thousands 00:30:57.160 --> 00:30:58.780 of local pharmacies. 00:30:58.780 --> 00:31:01.120 And in different parts of the country, 00:31:01.120 --> 00:31:02.980 we call them mom and pops. 00:31:02.980 --> 00:31:05.010 If we put in an RFID system they're 00:31:05.010 --> 00:31:07.180 associated with a more sophisticated system, 00:31:07.180 --> 00:31:10.660 can these pharmacies be able to authenticate the product 00:31:10.660 --> 00:31:12.370 when we receive it? 00:31:12.370 --> 00:31:15.790 Do they have the cost infrastructure to do so? 00:31:15.790 --> 00:31:19.600 I know we need standards. 00:31:19.600 --> 00:31:21.970 I'm also part of the Information Work 00:31:21.970 --> 00:31:24.650 Group working within the BAG. 00:31:24.650 --> 00:31:28.780 What we really need to have is the information model, 00:31:28.780 --> 00:31:32.458 the logical models, the flow associated with it. 00:31:32.458 --> 00:31:34.000 You guys, I know some of the speakers 00:31:34.000 --> 00:31:36.798 here today attempted to bridge into that 00:31:36.798 --> 00:31:37.840 without talking about it. 00:31:37.840 --> 00:31:41.980 But if we really need the rules as an IT organization 00:31:41.980 --> 00:31:44.680 to do synchronization, validation, ownership, 00:31:44.680 --> 00:31:47.620 retention, security, Florida says 00:31:47.620 --> 00:31:50.980 we have to keep the records for a pedigree for three years. 00:31:50.980 --> 00:31:54.093 We generate-- oh no. 00:31:54.093 --> 00:31:56.260 I'm not going to go through the numbers of McKesson, 00:31:56.260 --> 00:31:58.360 but there's a lot of orders. 00:31:58.360 --> 00:32:00.580 We generate an order for each customer every day 00:32:00.580 --> 00:32:02.110 of the year in Florida. 00:32:02.110 --> 00:32:04.020 We do an overnight delivery model. 00:32:04.020 --> 00:32:06.520 So how many pedigrees do we need to create for every product 00:32:06.520 --> 00:32:07.300 there? 00:32:07.300 --> 00:32:10.390 We cannot afford to create a paper pedigree-based system, 00:32:10.390 --> 00:32:12.610 and Florida allows a paper pedigree system. 00:32:12.610 --> 00:32:15.110 And there's no integrity in a paper pedigree system, really. 00:32:19.270 --> 00:32:23.567 This is a little bit about evolution of hardware, 00:32:23.567 --> 00:32:24.650 software, and integration. 00:32:24.650 --> 00:32:27.670 But if you look at all the different architectural stacks 00:32:27.670 --> 00:32:31.030 and stuff, really, that middleware 00:32:31.030 --> 00:32:34.180 is expanding to the edge, and middleware is spanning upward 00:32:34.180 --> 00:32:35.510 into the enterprise. 00:32:35.510 --> 00:32:40.840 So there's no static model, so to speak, of technology. 00:32:40.840 --> 00:32:43.000 Here we are, moving from gen 1 to gen 2. 00:32:43.000 --> 00:32:46.210 So we're talking about agile readers. 00:32:46.210 --> 00:32:48.070 We're talking about-- we haven't really 00:32:48.070 --> 00:32:49.820 come up with a sense of understanding what 00:32:49.820 --> 00:32:51.310 are the firm frequencies associated 00:32:51.310 --> 00:32:52.310 with what we're going to do? 00:32:52.310 --> 00:32:53.950 How are we going to write these tags, and what 00:32:53.950 --> 00:32:55.048 should be on the tags? 00:32:55.048 --> 00:32:57.340 And then we have the performance issues with item-level 00:32:57.340 --> 00:32:58.430 tagging still to decide. 00:32:58.430 --> 00:33:03.100 So I think Chuck and Mike here really 00:33:03.100 --> 00:33:04.210 said the same things here. 00:33:04.210 --> 00:33:05.740 We really need your help here. 00:33:05.740 --> 00:33:07.420 Help us resolve these issues here, 00:33:07.420 --> 00:33:11.811 so that we can get this patient safety issue addressed. 00:33:15.500 --> 00:33:17.590 So a summary of issues here. 00:33:17.590 --> 00:33:20.920 Again, top of the list is really for us in health care. 00:33:20.920 --> 00:33:22.150 We're guided by HIPAA rules. 00:33:22.150 --> 00:33:25.330 We're guided by many different privacy and security practices 00:33:25.330 --> 00:33:26.260 already. 00:33:26.260 --> 00:33:31.720 We need one that allow us to do what we need to do, and not 00:33:31.720 --> 00:33:35.920 lose the confidence of what we have in our health care 00:33:35.920 --> 00:33:37.420 consumer base today. 00:33:37.420 --> 00:33:41.020 We cannot allow that to erode. 00:33:41.020 --> 00:33:42.430 So again, where's the data? 00:33:42.430 --> 00:33:44.500 How are we going to hold that data? 00:33:44.500 --> 00:33:46.600 The health care industry model today, 00:33:46.600 --> 00:33:49.785 it's held very closely to the vest, the data. 00:33:49.785 --> 00:33:51.160 So we need to come up with models 00:33:51.160 --> 00:33:55.720 that allow us to expand beyond our current supply chain model, 00:33:55.720 --> 00:33:58.510 and to say what is the economics associated with it. 00:34:01.120 --> 00:34:03.610 Product identification schema-- again, 00:34:03.610 --> 00:34:07.480 we talked about it in many different forums here today, 00:34:07.480 --> 00:34:10.929 a local schema versus the global schema. 00:34:10.929 --> 00:34:14.380 Obviously, the manufacturers have a global business. 00:34:14.380 --> 00:34:18.020 And yet the NDC number, which is the primary product 00:34:18.020 --> 00:34:21.850 identifier here in America, is used for claims processing. 00:34:21.850 --> 00:34:25.150 And a pharmacy, for them not to have that number on the product 00:34:25.150 --> 00:34:25.929 is a big deal. 00:34:30.070 --> 00:34:33.460 And also, I don't know if tagging 00:34:33.460 --> 00:34:35.650 was talked about by Chuck, obviously, in detail. 00:34:35.650 --> 00:34:37.989 Forward and reverse logistics participation-- 00:34:37.989 --> 00:34:40.594 obviously, if you look at the Florida model, 00:34:40.594 --> 00:34:42.219 it doesn't start with the manufacturer. 00:34:42.219 --> 00:34:44.830 It starts with the wholesaler. 00:34:44.830 --> 00:34:47.237 There's a few supply chain participants missing there 00:34:47.237 --> 00:34:48.070 in the middle here-- 00:34:48.070 --> 00:34:50.110 [CHUCKLES] 00:34:50.110 --> 00:34:52.000 --Including logistics guys. 00:34:52.000 --> 00:34:55.840 So we believe that, really, the best pedigree model 00:34:55.840 --> 00:34:58.510 contains all participants in the supply chain. 00:34:58.510 --> 00:34:59.980 There can't be going from one step 00:34:59.980 --> 00:35:03.820 to step three, and step two maybe if you have the time. 00:35:03.820 --> 00:35:06.155 [CHUCKLES] 00:35:06.155 --> 00:35:09.920 So what we're looking for is really state and FDA ePedigree 00:35:09.920 --> 00:35:10.420 model. 00:35:10.420 --> 00:35:12.040 We're looking for an electronic model. 00:35:12.040 --> 00:35:14.860 Electronic models, I believe the pedigree model 00:35:14.860 --> 00:35:17.410 itself is a pretty uniform model, in the sense 00:35:17.410 --> 00:35:20.590 that the problem that you can address, in terms 00:35:20.590 --> 00:35:24.310 of a pedigree model for health care 00:35:24.310 --> 00:35:27.100 can apply to consumer packaged goods. 00:35:27.100 --> 00:35:32.200 It can apply to the clothing industry, for example. 00:35:32.200 --> 00:35:33.790 So the model is pretty clear, but we 00:35:33.790 --> 00:35:35.810 need to define one across industries. 00:35:35.810 --> 00:35:37.510 And I think that would add significantly 00:35:37.510 --> 00:35:39.520 to the adoption associated with it. 00:35:42.940 --> 00:35:45.970 Tag frequency, technological maturity-- 00:35:45.970 --> 00:35:50.800 I caution, as a business, we have x number of dollars 00:35:50.800 --> 00:35:53.710 each year to invest into technology. 00:35:53.710 --> 00:35:56.530 What we need to have is an evolutionary step. 00:35:56.530 --> 00:35:58.297 We can't slowly evolve. 00:35:58.297 --> 00:36:00.130 We've got to have checkpoints along the way. 00:36:00.130 --> 00:36:02.320 I was talking to John earlier over lunch 00:36:02.320 --> 00:36:05.380 about the concept of we have to set the future vision of where 00:36:05.380 --> 00:36:06.940 we're going to go. 00:36:06.940 --> 00:36:08.872 Where are we going to be two years from now, 00:36:08.872 --> 00:36:11.080 three years from now, wherever the slice and dice is? 00:36:11.080 --> 00:36:14.660 But the end of year 1, we have to say to ourselves, 00:36:14.660 --> 00:36:16.870 we're all going to be x 12 by this date, 00:36:16.870 --> 00:36:19.342 and be able to accomplish these type of things. 00:36:19.342 --> 00:36:21.550 So that's what we're looking for here as an industry, 00:36:21.550 --> 00:36:24.190 because we can't do this incremental adoption approach, 00:36:24.190 --> 00:36:25.990 because it's a huge infrastructure we 00:36:25.990 --> 00:36:28.150 have to change overnight. 00:36:28.150 --> 00:36:30.880 Took us 30 years to get the barcode maturity. 00:36:30.880 --> 00:36:34.810 We cannot wait 30 years for RFID to become mature. 00:36:34.810 --> 00:36:37.780 We all understand the product of identification strength 00:36:37.780 --> 00:36:39.670 and the need for product identification, 00:36:39.670 --> 00:36:42.700 and the glory associated with understanding what else we can 00:36:42.700 --> 00:36:45.220 do with additional bits of information 00:36:45.220 --> 00:36:47.260 that we never had with the linear barcode. 00:36:47.260 --> 00:36:55.450 So again, what's a rational adoptions approach? 00:36:55.450 --> 00:36:58.810 For McKesson, a wholesale distributor, 00:36:58.810 --> 00:37:02.120 what percentage of product has to be enabled for us 00:37:02.120 --> 00:37:08.620 to make that a non-parallel set of technologies, so to speak? 00:37:08.620 --> 00:37:11.320 I can't be scanning product with barcodes in one hand, 00:37:11.320 --> 00:37:13.063 and then using RFID on the other. 00:37:13.063 --> 00:37:14.230 It doesn't save me any time. 00:37:14.230 --> 00:37:16.272 If I close the tote and I have to open it back up 00:37:16.272 --> 00:37:19.060 to scan those products that are not RFID-enabled versus guys 00:37:19.060 --> 00:37:20.770 that are barcode-enabled. 00:37:20.770 --> 00:37:24.220 So we have to reach a level of maturity in adoption 00:37:24.220 --> 00:37:26.020 as quickly as possible. 00:37:26.020 --> 00:37:29.280 And that would be everybody in the supply chain again. 00:37:29.280 --> 00:37:31.090 And that goes back to the cost dollars. 00:37:31.090 --> 00:37:33.350 It goes back to the evolutionary aspects of it. 00:37:33.350 --> 00:37:38.370 So it's really not a focus on technology. 00:37:38.370 --> 00:37:39.560 I don't want to make-- 00:37:39.560 --> 00:37:41.350 I know we're a technology group here. 00:37:41.350 --> 00:37:44.183 We really need to focus on the long-term vision in terms 00:37:44.183 --> 00:37:45.600 of a business set of requirements, 00:37:45.600 --> 00:37:47.558 and saying we're going to sell safe and secure, 00:37:47.558 --> 00:37:49.470 we're going to sell reverse logistics 00:37:49.470 --> 00:37:51.000 or operational efficiencies. 00:37:51.000 --> 00:37:54.970 One make may follow the other on a logical basis. 00:37:54.970 --> 00:37:58.660 But when you develop a sense of solutions-- 00:37:58.660 --> 00:38:01.410 and when I say ePedigree, to me, that's a business scenario, 00:38:01.410 --> 00:38:03.540 and what are supporting technologies that 00:38:03.540 --> 00:38:06.480 allow us to get to step one, and then further out, 00:38:06.480 --> 00:38:09.810 a second step associated with it? 00:38:09.810 --> 00:38:11.490 And that's all I really had to say. 00:38:11.490 --> 00:38:13.470 I want to keep to our time here. 00:38:13.470 --> 00:38:17.670 So I'm sure we're up here for a few questions here. 00:38:17.670 --> 00:38:23.032 [APPLAUSE] 00:38:23.032 --> 00:38:24.490 STEPHEN MILES: Thank you very much. 00:38:24.490 --> 00:38:25.907 If we could come down to the front 00:38:25.907 --> 00:38:27.433 of the room for any questions? 00:38:33.360 --> 00:38:35.125 You just handed us a big menu. 00:38:35.125 --> 00:38:39.070 [LAUGHTER] 00:38:39.070 --> 00:38:42.180 Picking up on themes from throughout the day. 00:38:47.394 --> 00:38:50.300 AUDIENCE: Hi, I'm Alfonso Gutierrez from the University 00:38:50.300 --> 00:38:51.500 of Wisconsin, Madison. 00:38:54.110 --> 00:38:56.150 In the beginning of the presentation, 00:38:56.150 --> 00:38:59.180 you had a big slide saying that it's for the patient's safety. 00:39:01.700 --> 00:39:08.090 We're working in some of the blood products 00:39:08.090 --> 00:39:11.330 on a supply chain, and a big issue that we're dealing with 00:39:11.330 --> 00:39:15.245 is the patient identification. 00:39:15.245 --> 00:39:16.370 This is called the patient. 00:39:16.370 --> 00:39:18.140 And at the end of all of this, it's 00:39:18.140 --> 00:39:20.630 a patient who is receiving this. 00:39:20.630 --> 00:39:23.030 Different than the consumer products, 00:39:23.030 --> 00:39:25.100 we have to tie in with the patient. 00:39:25.100 --> 00:39:28.190 It's not only the consumer that we can just 00:39:28.190 --> 00:39:32.420 send the product out and we don't care who bought it. 00:39:32.420 --> 00:39:35.060 Who's dealing with this? 00:39:35.060 --> 00:39:39.830 Who's skinning this cat of patient identification? 00:39:39.830 --> 00:39:43.770 Should it be in parallel with all of this? 00:39:43.770 --> 00:39:46.000 [INTERPOSING VOICES] 00:39:46.000 --> 00:39:48.230 MICHAEL ROSE: I think it's an excellent point. 00:39:48.230 --> 00:39:52.540 I think this whole area of linking prescriptions 00:39:52.540 --> 00:39:54.350 to devices-- 00:39:54.350 --> 00:39:58.190 because the common connection is the patient. 00:39:58.190 --> 00:40:03.080 So you really don't see anyone solving that problem right now. 00:40:03.080 --> 00:40:05.510 One hope on the horizon, though, is 00:40:05.510 --> 00:40:07.730 there's quite a bit of movement in the government. 00:40:07.730 --> 00:40:11.150 Dr. Brailer's organization is looking 00:40:11.150 --> 00:40:14.600 at helping improve the health care 00:40:14.600 --> 00:40:18.590 system, the application of IT. 00:40:18.590 --> 00:40:21.960 That's an area that is taking a look at this. 00:40:21.960 --> 00:40:23.990 So we would expect some of the work that's 00:40:23.990 --> 00:40:26.360 going on there may eventually move 00:40:26.360 --> 00:40:29.600 in that particular direction. 00:40:29.600 --> 00:40:31.670 The other area, there's an association 00:40:31.670 --> 00:40:34.010 called NAHIT, National Association of Health 00:40:34.010 --> 00:40:37.483 Information Technology. 00:40:37.483 --> 00:40:38.900 It's certainly within their brief, 00:40:38.900 --> 00:40:43.460 and they commissioned a study last year 00:40:43.460 --> 00:40:48.890 around the adoption of RFID and other auto-ID technologies, 00:40:48.890 --> 00:40:51.440 not just for products, but also for patients, too. 00:40:51.440 --> 00:40:52.730 So I agree with you. 00:40:52.730 --> 00:40:55.697 It's an issue, but it's still very fragmented 00:40:55.697 --> 00:40:58.280 and needs to be brought together in a more coordinated manner. 00:41:02.200 --> 00:41:06.230 TED NG: Also, from my perspective, 00:41:06.230 --> 00:41:10.400 RFID and patient identification probably don't go together 00:41:10.400 --> 00:41:11.870 on the same chip, so to speak. 00:41:11.870 --> 00:41:13.470 [LAUGHS] 00:41:13.470 --> 00:41:17.210 I think that there's a privacy-- 00:41:17.210 --> 00:41:18.270 the HIPAA laws. 00:41:18.270 --> 00:41:18.860 I don't know if you guys are familiar 00:41:18.860 --> 00:41:20.150 with the federal HIPAA-- 00:41:20.150 --> 00:41:23.570 Health Care Insurance Portability Accountability Act. 00:41:23.570 --> 00:41:27.920 That requires that data be secured, and have 00:41:27.920 --> 00:41:31.430 privacy concerns associated with the linking of personally 00:41:31.430 --> 00:41:32.700 identififable information. 00:41:32.700 --> 00:41:36.710 So I don't think it'll be on the product 00:41:36.710 --> 00:41:39.350 that you get from the pharmacy. 00:41:39.350 --> 00:41:42.860 There might be a pharmacy number or a script number. 00:41:42.860 --> 00:41:45.890 But again, your patient information 00:41:45.890 --> 00:41:48.170 will be stored by the pharmacist. 00:41:48.170 --> 00:41:50.270 Additionally, again, there's another agency 00:41:50.270 --> 00:41:56.090 called HIMS, Healthcare Information Management and-- 00:41:56.090 --> 00:41:56.750 the two S's. 00:41:56.750 --> 00:41:58.375 [INAUDIBLE] 00:41:58.375 --> 00:42:00.660 Systems, Service-- yeah, systems along that line. 00:42:00.660 --> 00:42:02.660 Again, electronic medical records 00:42:02.660 --> 00:42:05.420 is the solution here somewhere along the way. 00:42:05.420 --> 00:42:08.030 Also in the federal bodies here, they're 00:42:08.030 --> 00:42:13.745 looking at trying to develop electronic medical records. 00:42:13.745 --> 00:42:15.200 BOB CELESTE: One of the areas that 00:42:15.200 --> 00:42:23.870 may be able to help you out with is that in Ireland does quite 00:42:23.870 --> 00:42:26.000 a bit of work [INAUDIBLE]. 00:42:26.000 --> 00:42:30.380 And they've got serialization in the spring of [INAUDIBLE].. 00:42:39.990 --> 00:42:42.990 AUDIENCE: We're all from the same school [INAUDIBLE] in MIT. 00:42:42.990 --> 00:42:46.560 Actually, we are doing some marketing research of the RFID 00:42:46.560 --> 00:42:48.900 in the drug tracking business. 00:42:48.900 --> 00:42:52.500 We found, actually, the business is growing very fast-- 00:42:52.500 --> 00:42:54.165 the market size. 00:42:54.165 --> 00:42:57.730 Like, in 2006, it's going to be 25%, 00:42:57.730 --> 00:43:00.870 and in 2007, it's going to be 30%. 00:43:00.870 --> 00:43:04.770 In 2011, it's going to be 40%, and it's going 00:43:04.770 --> 00:43:07.860 to exceed, like, $1 billion US. 00:43:07.860 --> 00:43:11.080 And I noticed that you have a summary of issues. 00:43:11.080 --> 00:43:14.150 One thing I'm specifically interested in, we obviously 00:43:14.150 --> 00:43:18.930 didn't get a chance to explore more, is the data network-- 00:43:18.930 --> 00:43:24.750 I mean, central distributor, and also the secure access, 00:43:24.750 --> 00:43:30.870 when you have all this networked software located everywhere, 00:43:30.870 --> 00:43:32.250 probably globally. 00:43:32.250 --> 00:43:35.040 Is there any initiation or any research 00:43:35.040 --> 00:43:37.050 in that area, like how you guarantee 00:43:37.050 --> 00:43:41.675 that data is right before you get it into the network? 00:43:41.675 --> 00:43:43.050 BOB CELESTE: So one of the things 00:43:43.050 --> 00:43:46.200 that we'll be doing this year is the track and trace effort. 00:43:46.200 --> 00:43:49.050 And that will, first off, define a vocabulary 00:43:49.050 --> 00:43:50.490 that the health care industry will 00:43:50.490 --> 00:43:52.710 use to identify [INAUDIBLE] events 00:43:52.710 --> 00:43:55.480 and understand them from a business perspective. 00:43:55.480 --> 00:43:57.786 Part of that again, overlaying everything, 00:43:57.786 --> 00:44:00.600 is the security aspect. 00:44:00.600 --> 00:44:03.540 And so [INAUDIBLE],, in this case a software, 00:44:03.540 --> 00:44:06.090 actually, we're running security around the network 00:44:06.090 --> 00:44:08.430 to ensure that data is safe. 00:44:08.430 --> 00:44:13.620 But that's part of our 2006 effort. 00:44:13.620 --> 00:44:19.400 TED NG: Again, it's part of the development of the entire-- 00:44:19.400 --> 00:44:22.730 if you're looking at just any pedigree alone, 00:44:22.730 --> 00:44:26.150 you're going to have to define business process rules as to-- 00:44:26.150 --> 00:44:28.265 at what point is it-- 00:44:28.265 --> 00:44:30.140 what part of record, so to speak, [INAUDIBLE] 00:44:30.140 --> 00:44:32.000 pedigree record is created. 00:44:32.000 --> 00:44:34.910 Who creates a track, who creates a trace, who 00:44:34.910 --> 00:44:37.920 creates the authentication side, the product identification 00:44:37.920 --> 00:44:38.420 side? 00:44:38.420 --> 00:44:40.040 And what part of the supply chain, 00:44:40.040 --> 00:44:41.930 in terms of the supply chain participants, 00:44:41.930 --> 00:44:44.930 are required to update this? 00:44:44.930 --> 00:44:46.640 Because if you want a good pedigree, 00:44:46.640 --> 00:44:48.620 all the players have to play, and each of them 00:44:48.620 --> 00:44:51.800 have a role to play. 00:44:51.800 --> 00:44:54.530 STEPHEN MILES: I've got a question regarding 00:44:54.530 --> 00:44:57.050 chemical and thermal stability of drug compounds. 00:44:57.050 --> 00:44:58.550 Can you say anything on tests you've 00:44:58.550 --> 00:45:00.300 done with respect to different frequencies 00:45:00.300 --> 00:45:04.820 of different RFID systems and their outcomes? 00:45:04.820 --> 00:45:06.480 MICHAEL ROSE: It's an area-- and I 00:45:06.480 --> 00:45:11.370 know the Auto-ID Labs here at MIT have proposed to study. 00:45:11.370 --> 00:45:15.090 It's an area that's still out for investigation. 00:45:18.800 --> 00:45:20.550 Without divulging anything, some companies 00:45:20.550 --> 00:45:22.800 have done some work that we're aware of. 00:45:22.800 --> 00:45:24.420 But it's not been made public yet. 00:45:27.420 --> 00:45:29.310 And I think what's going to be required-- 00:45:29.310 --> 00:45:30.977 and I think you're going to see, the FDA 00:45:30.977 --> 00:45:32.550 has a meeting on February 8 and 9. 00:45:32.550 --> 00:45:35.490 It's going to be another call for companies to come forward 00:45:35.490 --> 00:45:36.210 with public data. 00:45:36.210 --> 00:45:39.720 They made that call at the [INAUDIBLE] HDMA meeting back 00:45:39.720 --> 00:45:42.120 last fall. 00:45:42.120 --> 00:45:43.620 I think the challenge that companies 00:45:43.620 --> 00:45:46.650 have around this investigation is, what's 00:45:46.650 --> 00:45:48.930 the design of experiment? 00:45:48.930 --> 00:45:50.560 What's the endpoint of that experiment? 00:45:50.560 --> 00:45:54.055 And that's what everyone's struggling with right now. 00:45:54.055 --> 00:45:54.930 AUDIENCE: OK, thanks. 00:45:58.297 --> 00:46:00.730 STEPHEN MILES: So thank you very much to the panel. 00:46:00.730 --> 00:46:02.580 [APPLAUSE]